Text · Amendment list
Laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
Full title
Laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
Document ENVI-AM-756136 · COM(2023)0193 – C9-0144/2023 – 2023/0131(COD)
- Kind
- Amendment list ENVI-AM-756136
- Date
- 21 November 2023
- Committee
- Committee on the Environment, Public Health and Food Safety
- Dossier
- 2023-0131
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- Formats
- Official page PDF Word
- Reference
- COM(2023)0193 – C9-0144/2023 – 2023/0131(COD)
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| Text proposed by the Commission | Amendment |
|---|---|
| 4 a. An orphan medicinal product which benefits from the prolongation of market exclusivity as referred to in paragraph 3, shall not benefit from the rewards referred to in Article 86 [of revised Directive 2001/83/EC]. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4 b. The holder of an orphan marketing authorisation shall be entitled to a total maximum period of 14 years of orphan marketing exclusivity from the time the orphan medicinal product in question first obtains an authorization as defined in Article 69. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article72a | |
| Improving accessibility of Orphan Medicinal Products placed on the Union markets | |
| 1. An applicant for marketing authorisation for an orphan medicinal product benefitting from a period of market exclusivity shall demonstrate as part of its application process, that it has fulfilled the following measures to ensure improved access to the orphan medicinal product within the Union: | |
| (a) it has developed a detailed roadmap for entering into a partnership with relevant European Reference Networks, working on the orphan medical conditions for which the orphan medicinal product holds an indication; | |
| (b) it has established, without prejudice to proprietary data and trade secrets, an in-depth communication strategy regarding the orphan medicinal product, its indications, its method of action, expected effects on the relevant patient population; this information shall be communicated to clinicians in the Union working with the relevant patient populations, with the cooperation of the Member States, as well as patient and professional organisations; | |
| 2. Member States shall adopt appropriate and adequate measures within their national legislation to improve patient access to orphan medicinal products authorised for placement on the Union markets by adopting national Action Plans for Rare Diseases that include at least the following elements: | |
| (a) fully transposing Directive 2011/24/EU and guaranteeing the fulfillment of patients' rights to cross-border healthcare in every Member State; where necessary, set up the appropriate pathways for patients suffering from rare diseases to benefit from Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems, in order to access orphan medicinal products available in other Member States; | |
| (b) establishing, individually or through voluntary cooperation with other Member States, Centres of Excellence for the management and care of patients with rare diseases; | |
| (c) putting in place, in cooperation with the Agency, the necessary infrastructure to ensure a high level of uptake by clinicians and other medical professionals of information regarding the latest orphan medicinal products, authorised to be placed on the Union market; | |
| (d) ensuring a sufficient level of financial support for existing and future Europan Reference Networks, guaranteeing their capability to generate, collect and analyse real-world data; setting up robust frameworks for partnerships between ERNs, national regulators and marketing authorisation holders for orphan medicinal products, for the purpose of data collection and analysis; |
| Text proposed by the Commission | Amendment |
|---|---|
| Article73a | |
| Reporting of research and development costs from the marketing authorisation holder | |
| 1. Where the marketing authorisation holder benefits from the incentives outlined in Article 71 paragraph 2, it shall: | |
| (a) upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an report with detailed information on their actual costs and expenditure in research and development activities related to the medicinal product. | |
| (b) make the report available within 30 days from the receipt of the request; | |
| (c) publish a summary of the report on the same webpage where the information described in Article 57 of revised Directive 2001/83/EC will be published. The link should be communicated to the Agency. | |
| (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. | |
| 2. The Commission shall adopt implementing acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article73a | |
| Reporting of research and development costs from the marketing authorisation holder | |
| 1. Where the marketing authorisation holder benefits from the incentives outlined in Article 71 paragraph 2, it shall: | |
| (a)upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an electronic report with detailed information on their expenditure in research and development activities related to the medicinal product; | |
| (b) make the report available within 30 days from the receipt of the request; | |
| (c) publish a summary of the report on the same webpage where the information described in Article 57 of revised Directive 2001/83/EC will be published. The link should be communicated to the Agency; | |
| (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. | |
| 2. The Commission shall adopt implementing acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1. |
Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen, Dacian Cioloş
| Text proposed by the Commission | Amendment |
|---|---|
| Article 73a | |
| European Framework for Rare Diseases | |
| By (OP: 24 months after the date of entry into force of this Regulation), the Commission shall, following appropriate consultation with the Member States, patient organisations and, where relevant, other interested parties, propose a needs driven and goals based European Framework for Rare Diseases with a view to bridge relevant Union legislation, policies and programmes, and support national strategies to better meet the unmet needs of people living with rare diseases, and their carers. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article73b | |
| Joint procurement of orphans, drugs against cancer and advanced therapy medicinal products | |
| 1. Upon request from the Member States, the Commission shall facilitate joint procurement of orphans, drugs against cancer and advanced therapy medicinal products at the EU level on Member States' behalf going beyond the emergency situations under the Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. | |
| 2. The Commission is empowered to establish the EU Pharmaceutical Fund. Each Member State may contribute to the EU Pharmaceutical Fund by paying, for each unit used within the Member State, a given amount, which is defined considering the Member State's ability to pay based on GDP per-capita.To ensure financial sustainability of the EU Pharmaceutical Fund, country-specific contributions shall be such as to ensure balance between the total expected amount to be paid to the manufacturer and the expected total amount of contributions made by Member States. | |
| 3. The Commission is empowered to adopt delegated act in accordance with this Article to supplement this Regulation by further defining the scheme, conditions of participation of Member States in joint procurements of orphans, drugs against cancer and advanced therapy medicinal products at the EU level and funding of EU Pharmaceutical Fund. |
Joint procurement of medicines can be a successful form of increased cooperation to improve affordability as well as access to medicines and security of supply. This has been demonstrated by the joint procurement of COVID-19 therapeutics and monkeypox vaccines. However, the potential of the EU joint procurements reaches beyond vaccines and treatments for communicable cross-border health threats. New STOA paper on Improving access to medicines and promoting pharmaceutical innovation choose joint procurements as the Policy Option 1 (p. 61-62) for Improving access to medicine of EU patients.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) when the active substance concerned is not yet authorised in any medicinal product in the EU and is intended to treat a novel paediatric condition; | (a) when the active substance concerned is not yet authorised in any medicinal product in the EU and is intended to treat, diagnose or prevent a paediatric condition; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) when the active substance concerned is not yet authorised in any medicinal product in the EU and is intended to treat a novel paediatric condition; | (a) when the active substance concerned is the first of its kind intended to treat, diagnose or prevent a paediatric condition; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless when the product is directed at a molecular target that on the basis of existing scientific data, is responsible for a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population; | (b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless on the basis of existing scientific data, there is medical plausibility that the product, due to its mechanism of action, could address an unmet medical need in a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population. Where that is the case, the applicant shall be required to conduct one paediatric investigation plan based on the product’s mechanism of action in a single disease or condition for which there is such an unmet medical need, and no more than one such paediatric investigation plan for any given active substance; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless when the product is directed at a molecular target that on the basis of existing scientific data, is responsible for a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population; | (b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless on the basis of existing scientific data, there is medical plausibility that the product, due to its mechanism of action, could address an unmet medical need in a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population. Where that is the case, the applicant shall be required to conduct one paediatric investigation plan based on the product’s mechanism of action in a single disease or condition for which there is such an unmet medical need; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless when the product is directed at a molecular target that on the basis of existing scientific data, is responsible for a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population; | (b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless there is medical plausibility that the product, due to its mechanism of action and on the basis of existing scientific data, could address an unmet medical need in a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless when the product is directed at a molecular target that on the basis of existing scientific data, is responsible for a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population; | (b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless on the basis of existing scientific data, there is medical plausibility that the product, due to its mechanism of action, could address an unmet medical need in a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing treatments for paediatric patients. | (c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing methods of diagnosis, prevention or treatments for paediatric patients, including when clinical studies are not feasible. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing treatments for paediatric patients. | (c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing methods of diagnosis, prevention or treatments for paediatric patients, including when clinical studies are not feasible. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing treatments for paediatric patients. | (c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing methods of diagnosis, prevention or treatments for paediatric patients. |
Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen, Dacian Cioloş
| Text proposed by the Commission | Amendment |
|---|---|
| (c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing treatments for paediatric patients. | (c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing methods of diagnosis, prevention or treatment for paediatric patients. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1 a. The Agency shall, after consultation with the Commission and relevant interested parties, draw up guidelines for the application of this Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. On the basis of the experience acquired as a result of the operation of this Article or of scientific knowledge the Commission is empowered to adopt delegated acts in accordance with Article 175 to amend the grounds for granting a waiver detailed in paragraph 1. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 3 a. In consultation with the Commission and with interested parties, the Agency shall draw up guidelines for the application of this Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3 a. The Agency shall, in consultation with the Commission and with all interested parties, draw up guidelines for the application of this Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3 a. In consultation with the Commission and with interested parties, the Agency shall draw up guidelines for the application of this Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of safety and efficacy clinical studies so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned. | 1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of confirmatory safety and efficacy clinical studies in adults or children so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of safety and efficacy clinical studies so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned. | 1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation confirmatory of safety and efficacy clinical studies in adults or children so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of safety and efficacy clinical studies so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned. | 1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of confirmatory safety and efficacy clinical studies in adults or children so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of safety and efficacy clinical studies so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned. | 1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of confirmatory safety and efficacy clinical studies so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. In consultation with the Commission and with interested parties, the Agency shall draw up and publish guidelines for the practical application of this Article. | 4. In consultation with the Commission and with interested parties, and with the CPOMP, the Agency shall draw up and publish guidelines for the practical application of this Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt within 90 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate. | 1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1), which is valid in accordance with the provisions of Article 76(2), the Agency shall, after receiving the opinion of its paediatric working party, adopt within 90 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate. |
The paediatric working party's opinion should be taken into consideration on account of its scientific competence in supporting the development of the Agency's regulatory experience
| Text proposed by the Commission | Amendment |
|---|---|
| 1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt within 90 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate. | 1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt within 80 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt within 90 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate. | 1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt within 70 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. After the validation of the proposed initial paediatric investigation plan prepared in accordance with the adapted procedure referred to in Article 74(2) first subparagraph, which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt a decision within 70 days as to whether or not the paediatric investigation plan is expected to ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies envisaged. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. After receiving an updated version of the paediatric investigation plan referred to in Article 74(2), third subparagraph, the Agency shall review it within 30 days. | deleted |
| After the timeframe laid down in the first subparagraph, without any request from the Agency in accordance with paragraph 5, the updated version of the paediatric investigation plan shall be considered as agreed. |
| Text proposed by the Commission | Amendment |
|---|---|
| After receiving an updated version of the paediatric investigation plan referred to in Article 74(2), third subparagraph, the Agency shall review it within 30 days. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| After receiving an updated version of the paediatric investigation plan referred to in Article 74(2), third subparagraph, the Agency shall review it within 30 days. | After receiving an updated version of the paediatric investigation plan referred to in Article 74(2), third subparagraph, the Agency shall, after receiving the input of the paediatric working party, review it within 30 days. |
The paediatric working party's opinion should be taken into consideration on account of its scientific competence in supporting the development of the Agency's regulatory experience
| Text proposed by the Commission | Amendment |
|---|---|
| After the timeframe laid down in the first subparagraph, without any request from the Agency in accordance with paragraph 5, the updated version of the paediatric investigation plan shall be considered as agreed. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. When the final paediatric investigation plan referred to in Article 74(2), third subparagraph, is received, the Agency shall adopt within 60 days a decision on the paediatric investigation plan considering all the updated reviews eventually conducted and of the initial decision in accordance with paragraphs 2 and 3. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Within time periods referred to in paragraphs 1, 2, 3 or 4 the Agency may request the applicant to propose modifications to the plan or ask for additional information, in which case the time-limits referred to in paragraphs 1, 2, 3 and 4 shall be extended for a maximum of the same number of days. These time-limits shall be suspended until the supplementary information requested has been provided. | 5. Within the time period referred to in paragraph 1, the Agency may request the applicant to propose modifications to the plan or ask for additional information, in which case the time-limit shall be extended for a maximum of the same number of days. This time-limit shall be suspended until the supplementary information requested has been provided. |
| Text proposed by the Commission | Amendment |
|---|---|
| Following the receipt of a valid application in accordance with the provisions of Article 76(2), the Agency shall within 90 days adopt a decision as to whether or not a product-specific waiver shall be granted. | Following the receipt of a valid application in accordance with the provisions of Article 76(2), the Agency shall, after receiving the input of its paediatric working party, within 90 days adopt a decision as to whether or not a product-specific waiver shall be granted. |
The paediatric working party should also be involved in the granting of product-specific derogations.
| Text proposed by the Commission | Amendment |
|---|---|
| 3. When appropriate, the Agency may of its own motion adopt decisions, on the basis of the grounds set out in Article 75(1), to the effect that a class or a product-specific waiver, as referred to in Article 75(2), should be granted. | 3. When appropriate, the Agency may, either of its own motion or acting upon the recommendations of the paediatric working party, adopt decisions on the basis of the grounds set out in Article 75(1), to the effect that a class or a product-specific waiver, as referred to in Article 75(2), should be granted. |
The paediatric working party should also be involved in the granting of product-specific derogations.
| Text proposed by the Commission | Amendment |
|---|---|
| 7. In consultation with the Commission and with interested parties, the Agency shall draw up and publish guidelines for the practical application of this Article. | 7. In consultation with the Commission and with interested parties, the Agency and its paediatric working party shall draw up and publish guidelines for the practical application of this Article. |
The paediatric working party should also be involved in the granting of product-specific derogations.
| Text proposed by the Commission | Amendment |
|---|---|
| 7. In consultation with the Commission and with interested parties, the Agency shall draw up and publish guidelines for the practical application of this Article. | 7. In consultation with the Commission and with interested parties, and with the CPOMP, the Agency shall draw up and publish guidelines for the practical application of this Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| If, having considered a paediatric investigation plan, the Agency concludes that Article 75(1), points (a), (b) or (c), applies to the medicinal product concerned, it shall adopt negative a decision under Article 77, paragraphs 1, 2 or 4. | If, having considered a paediatric investigation plan, the Agency concludes that Article 75(1), points (a), (b) or (c), applies to the medicinal product concerned, it shall adopt negative a decision under Article 77, paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Agency shall adopt a decision on the request referred to in paragraph 1 and inform the applicant thereof. The Agency shall adopt such decision at the same time as the adoption of the positive decision under Article 77, paragraphs 1 or 2. | The Agency shall adopt a decision on the request referred to in paragraph 1 and inform the applicant thereof. The Agency shall adopt such decision at the same time as the adoption of the positive decision under Article 77, paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years. | 3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years and should ensure that the PIP is completed no more than two years after the marketing authorisation for other populations is granted. |
Reducing the length of the deferral may not be sufficient to reduce the significant backlog in approving paediatric medicinal products; the duration of the PIP shall not exceed two years after the granting of the marketing authorisation for medicinal products for other populations.
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years. | 3. The length of the deferral shall be specified in a decision of the Agency and shall be substantiated by scientific and technical reasoning or by considerations pertaining to public health. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years. | 3. The length of the deferral shall be specified in a decision of the Agency and shall be justified on scientific and technical grounds or on grounds relating to public health. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The length of the deferral shall be specified in a decision of the Agency and shall not exceed five years. | 3. The length of the deferral shall be specified in a decision of the Agency. |
| Text proposed by the Commission | Amendment |
|---|---|
| In duly justified cases, a request for a prolongation of the deferral, may be submitted, at least 6 months before the expiry of the deferral period. A prolongation of the derogation shall not exceed the duration of the deferral period given under Article 81(3). | In duly justified cases, a request for a prolongation of the deferral may be submitted. |
| Text proposed by the Commission | Amendment |
|---|---|
| In duly justified cases, a request for a prolongation of the deferral, may be submitted, at least 6 months before the expiry of the deferral period. A prolongation of the derogation shall not exceed the duration of the deferral period given under Article 81(3). | In duly justified cases, a request for a prolongation of the deferral, may be submitted, at least 12 months before the expiry of the deferral period. A prolongation of the derogation shall not exceed the duration of the deferral period given under Article 81(3). |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 a. In case of the product that has already been authorized for use in adults in accordance with the provision of this Regulation, and if the cause for deferral of the PIP was a failure to timely complete clinical studies in children, before granting another deferral, the Agency may consider the evidence obtained from extrapolation and from the appropriately designed post-marketing long-term studies for monitoring safety and efficacy as specified in Article 138, paragraph 1, subparagraph 2, point za a(new) |
| Text proposed by the Commission | Amendment |
|---|---|
| 1 a. The procedure foreseen in paragraph 1 shall also apply when the applicant updates the elements of an initial paediatric investigation plan submitted in accordance with Article 74(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| 1 a. The procedure foreseen in paragraph 1 shall also apply when the applicant updates the elements of an initial paediatric investigation plan submitted in accordance with Article 74(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| If, following the decision agreeing the paediatric investigation plan referred to in Article 77, paragraphs 1, 2 and 4, or on the basis of the updated paediatric investigation plan received in accordance with Article 77(3), the Agency, on the base of new scientific information available, considers that the agreed plan or any of its elements are no longer appropriate, it shall request the applicant to propose changes to the paediatric investigation plan. | If, following the decision agreeing the paediatric investigation plan referred to in Article 77, paragraph 1, the Agency, on the base of new scientific information available, considers that the agreed plan or any of its elements are no longer appropriate, it shall request based on detailed scientific grounds, that the to applicant proposes changes to the paediatric investigation plan. The applicant shall submit a response to the request for changes within 60 days. Within 30 days, the Agency shall review the applicant’s response and adopt a decision on its refusal or acceptance. |
| Text proposed by the Commission | Amendment |
|---|---|
| If, following the decision agreeing the paediatric investigation plan referred to in Article 77, paragraphs 1, 2 and 4, or on the basis of the updated paediatric investigation plan received in accordance with Article 77(3), the Agency, on the base of new scientific information available, considers that the agreed plan or any of its elements are no longer appropriate, it shall request the applicant to propose changes to the paediatric investigation plan. | If, following the decision agreeing the paediatric investigation plan referred to in Article 77, paragraph 1, the Agency, on the base of new scientific information available, considers that the agreed plan or any of its elements are no longer appropriate, it shall request, based on detailed scientific grounds, that the applicant propose changes to the paediatric investigation plan. |
| Text proposed by the Commission | Amendment |
|---|---|
| The applicant shall submit the changes requested within 60 days. | The applicant shall submit a response to the request for changes within 60 days. |
| Text proposed by the Commission | Amendment |
|---|---|
| The applicant shall submit the changes requested within 60 days. | The applicant shall submit a response to the request for changes within 90 days. |
| Text proposed by the Commission | Amendment |
|---|---|
| The applicant shall submit the changes requested within 60 days. | The applicant shall submit the changes requested within 90 days. |
| Text proposed by the Commission | Amendment |
|---|---|
| Within 30 days, the Agency shall review these changes and adopt a decision on their refusal or acceptance. | Within 30 days, and after receiving the opinion of its paediatric working party, the Agency shall review these changes and adopt a decision on their refusal or acceptance. |
The paediatric working party should also be involved in the granting of product-specific derogations.
| Text proposed by the Commission | Amendment |
|---|---|
| Within 30 days, the Agency shall review these changes and adopt a decision on their refusal or acceptance. | Within 30 days, the Agency shall review the applicant’s response and adopt a decision on its refusal or acceptance. |
| Text proposed by the Commission | Amendment |
|---|---|
| Within 30 days, the Agency shall review these changes and adopt a decision on their refusal or acceptance. | Within 30 days, the Agency shall review the applicant’s response and adopt a decision on its refusal or acceptance. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. In consultation with the Member States, the Commission and interested parties, the Agency shall draw up the detailed arrangements concerning the format and content which applications for agreement or modification of a paediatric investigation plan, and requests for waivers or deferrals are to follow in order to be considered valid and concerning the operation of the compliance check referred to in Articles 48, 49(2), 86 and 90(2) of [revised Directive 2001/83/EC]. | 1. In consultation with the Member States, the Commission, and interested parties, the Agency and its relevant Committee (CPOMP) shall draw up the detailed arrangements concerning the format and content which applications for agreement or modification of a paediatric investigation plan, and requests for waivers or deferrals are to follow in order to be considered valid and concerning the operation of the compliance check referred to in Articles 48, 49(2), 86 and 90(2) of [revised Directive 2001/83/EC]. |
| Text proposed by the Commission | Amendment |
|---|---|
| The paediatric experts who are taking part in the CHMP's working parties shall contribute to the conformity assessment. |
For this action it is necessary to those involve paediatric experts who have been working with the CHMP.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Decisions referred to in Articles 77, 78, 80, 81, 82 and 84 adopted by the Agency shall be supported by scientific conclusions which shall be annexed to the decision. | 1. Decisions referred to in Articles 77, 78, 80, 81, 82 and 84 adopted by the Agency shall be supported by scientific conclusions, which should incorporate the opinion expressed by the paediatric working party and which shall be annexed to the decision. |
All the activities linked in these articles have been assigned to the disbanded PDCO. It must be made clear that the scientific conclusions must be delivered by scientists who are expert in paediatric matters and who are part of one of the Agencies' paediatric working parties.
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when preparing the above mentioned scientific conclusions. The outcome of such consultations shall be annexed to the decision. | 2. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use and other appropriate working parties when preparing the above mentioned scientific conclusions. The outcome of such consultations shall be annexed to the decision. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 a. Within the timelines for adoption of a decision foreseen in Articles 77, 78, 80, 81, 82 and 84, the Agency shall transmit its scientific conclusions to the applicant. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 a. Within the timelines for adoption of a decision foreseen in Articles 77, 78, 80, 81, 82 and 84, the Agency shall transmit its scientific conclusions to the applicant. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 a. Within the timelines for adoption of a decision foreseen in Articles 77, 78, 80, 81, 82 and 84, the Agency shall transmit its scientific conclusions to the applicant. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 b. Within 20 days following receipt of the scientific conclusions, the applicant may submit to the Agency a written request, citing detailed grounds, for a re-examination. | |
| Within 30 days following receipt of a request for re-examination pursuant to paragraph 2b, the Agency shall confirm or revise its previous scientific conclusions.The Agency shall be able to question the applicant directly.The applicant may also offer to be questioned.Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re-examining the above mentioned scientific conclusions. | |
| If, within the 15-day period referred to in paragraph 4, the applicant does not request re-examination, the scientific conclusions shall become definitive. | |
| The Agency shall adopt a decision within a period not exceeding 15 days following the date on which the scientific conclusions have become definitive. This decision shall be communicated to the applicant in writing and shall annex the final scientific conclusions. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 b. Within 30 days following receipt of the scientific conclusions, the applicant may submit to the Agency a written request, citing detailed grounds, for a re-examination. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 b. Within 30 days following receipt of the scientific conclusions, the applicant may submit to the Agency a written request, citing detailed grounds, for a re-examination. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 c. Within 30 days following receipt of a request for re-examination pursuant to paragraph 2b, the Agency shall confirm or revise its previous scientific conclusions. The Agency shall be able to question the applicant directly. The applicant may also offer to be questioned. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re-examining the above mentioned scientific conclusions. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 c. Within 30 days following receipt of a request for re-examination pursuant to paragraph 4, the Agency shall confirm or revise its previous scientific conclusions. The Agency shall be able to question the applicant directly. The applicant may also offer to be questioned. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re-examining the above mentioned scientific conclusions. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 d. If, within the 30-day period referred to in paragraph 2b, the applicant does not request re-examination, the scientific conclusions shall become definitive. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 d. If, within the 30-day period referred to in paragraph 4, the applicant does not request re-examination, the scientific conclusions shall become definitive. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 e. The Agency shall adopt a decision within a period not exceeding 10 days following the date on which the scientific conclusions have become definitive. This decision shall be communicated to the applicant in writing and shall annex the final scientific conclusions. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 e. The Agency shall adopt a decision within a period not exceeding 10 days following the date on which the scientific conclusions have become definitive. This decision shall be communicated to the applicant in writing and shall annex the final scientific conclusions. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4, is discontinued, the applicant shall notify the Agency of its intention to discontinue the conduct of the paediatric investigation plan and provide the reasons for such discontinuation no less than six months before the discontinuation. | Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4, is discontinued, the applicant shall notify the Agency of its intention to discontinue the conduct of the paediatric investigation plan and provide the reasons for such discontinuation as soon as possible and no less than six months before the discontinuation. In cases where such a time-frame is not possible, the applicant shall notify the Agency no later than 6 months of its decision to discontinue the investigation plan. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4, is discontinued, the applicant shall notify the Agency of its intention to discontinue the conduct of the paediatric investigation plan and provide the reasons for such discontinuation no less than six months before the discontinuation. | Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4, is discontinued, the applicant shall notify the Agency of its intention to discontinue the conduct of the paediatric investigation plan and provide the reasons for such discontinuation no less than six months before the discontinuation or as soon as possible. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4 could not be completed due to failure of timely completion of pediatric studies, for the product that has already been authorized for use in adults in accordance with the provision of this Regulation, the Agency should consider evidence from the pediatric studies as specified in Article 138, paragraph 1, subparagraph 2, point za a(new) |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Any clinical study which involves the use in the paediatric population of a medicinal product covered by a marketing authorisation and is sponsored by the marketing authorisation holder, whether or not it is conducted in compliance with an agreed paediatric investigation plan, shall be submitted to the Agency or to the Member States which have previously authorised the medicinal product concerned within six months of completion of the studies concerned. | 1. Any clinical study which involves the use in the paediatric population of a medicinal product covered by a marketing authorisation and is sponsored by the marketing authorisation holder, whether or not it is conducted in compliance with an agreed paediatric investigation plan, shall be submitted to the Agency or to the Member States which have previously authorised the medicinal product concerned within 12 months of completion of the studies concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly. | 3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly, including regarding information on dosage accuracy. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly. | 3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, including the accurate dosage, and may vary the marketing authorisation accordingly. |
Paediatric medicinal products should be placed on the market in packaging that is fit for paediatric use, safe and suitable to use and that includes adapted leaflets and, to reduce medication errors, particular care should be taken to ensure that its dosages are accurate.
| Text proposed by the Commission | Amendment |
|---|---|
| 3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly. | 3. When products are authorised in accordance with the provisions of this Regulation, the Commission may update the summary of product characteristics and package leaflet, including dosage accuracy, and may vary the marketing authorisation accordingly. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3 a. By way of derogation of Article 91, paragraph 1, marketing authorisation holders of vaccines, any clinical study which involves the use in the paediatric population of a vaccine covered by a marketing authorisation and is sponsored by the marketing authorisation holder, whether or not it is conducted in compliance with an agreed paediatric investigation plan, shall be submitted to the Agency or to the Member States which have previously authorised the medicinal product concerned within twelve months of completion of the studies concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3 a. Where a medicinal product is covered by a marketing authorization for adults, and the paediatric authorisation could not be completed due to the inability to timely complete the pediatric clinical studies, instead of granting deferrals, the Agency should consider evidence from the pediatric studies defined in Article 138, paragraph 1, subparagraph 2, point za a(new) |
| Text proposed by the Commission | Amendment |
|---|---|
| Irrespective of the outcome of a clinical trial within 6 months from the end of the trial the clinical trial sponsor, the addressee of the Agency's decision on a paediatric investigation plan or the marketing authorisation holder as appropriate, shall submit to the EU database a summary of the results of the trial shall be uploaded in the database. | Irrespective of the outcome of a clinical trial within 12 months from the end of the trial the clinical trial sponsor, the addressee of the Agency's decision on a paediatric investigation plan or the marketing authorisation holder as appropriate, shall submit to the EU database a summary of the results of the trial shall be uploaded in the database. |
| Text proposed by the Commission | Amendment |
|---|---|
| If for justified scientific reasons it is not possible to submit the summary of the result of the trial within 6 months it shall be submitted to the EU database at the latest within twelve months after the trial has ended. The justification for the delay needs also to be submitted in the EU database. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 2 a. Within the European network, the Agency shall, together with the proposed members of the network, develop a platform study concept for paediatric patients. The objectives of the platform study concept are to create active paediatric patients’ master files open for future authorizations of the same molecules or molecules with the same mechanism of action, and/or to share the same pool of patients for joined clinical trials of industry and academia within the same administrative process. |
| Text proposed by the Commission | Amendment |
|---|---|
| Paediatric medicinal products shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, paediatric medicinal products. | Paediatric medicinal products shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, paediatric medicinal products. |
| These incentives will be granted by means of specific calls for research proposals encompassing the product's entire development phase, from discovery to post-marketing, as outlined in the annual paediatric research plans, which are part of the EU's research programmes concerning health and health products. |
A great deal of EU funding has been allocated to R&D programmes concerning health products in the field of paediatrics.
| Text proposed by the Commission | Amendment |
|---|---|
| (g) the renewals of the deferrals beyond five years and the detailed reasons provided as mentioned in Article 82; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure. | The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including errors of medication, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure. | The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including medication errors, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure. | The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including medication errors, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure |
| Text proposed by the Commission | Amendment |
|---|---|
| The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure. | The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including medication errors and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure. | The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation and medication errors, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure. | The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, including medication errors, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure |
This will allow more data on the number of medication errors that occur in Europe to be collected. The availability of consistent, reliable, data will support research and analysis on the root causes of medication errors which will contribute to evidence-based policy making on how to prevent medication harm in healthcare settings.
| Text proposed by the Commission | Amendment |
|---|---|
| The Agency shall ensure that healthcare professionals and the public have appropriate levels of access to the Eudravigilance database, and that personal data is protected. The Agency shall work together with all stakeholders, including research institutions, healthcare professionals, and patient and consumer organisations, in order to define the ‘appropriate level of access’ for healthcare professionals and the public to the Eudravigilance database. | The Agency shall ensure that healthcare professionals and the public have appropriate levels of access to the Eudravigilance database, and that personal data is protected in line with the EU data protection and privacy legislation. The Agency shall work together with all stakeholders, including research institutions, healthcare professionals, and patient and consumer organisations, in order to define the ‘appropriate level of access’ for healthcare professionals and the public to the Eudravigilance database. |
| Text proposed by the Commission | Amendment |
|---|---|
| The data held on the Eudravigilance database shall be made publicly available in an aggregated format together with an explanation of how to interpret the data. | The data held on the Eudravigilance database shall be made publicly available in an aggregated and anonymised format together with an explanation of how to interpret the data. Where anonymization is not possible, the data shall be pseudonymised. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission is empowered to adopt an implementing act to further specify the categories of personal data processed in the Eudravigilance database after consulting with and duly integrating the opinion of the European Data Protection Supervisor. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 17. |
| Text proposed by the Commission | Amendment |
|---|---|
| The periodic safety update reports shall, in addition, be made publicly available in the web-portal referred to in Article 135(1)(n). |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) a summary of the risk management plans for medicinal products authorised in accordance with this Regulation; | (c) risk management plans for medicinal products authorised in accordance with this Regulation; |
| Text proposed by the Commission | Amendment |
|---|---|
| (h) the initiation of the procedure provided for in Article 41(2), and Articles 114, 115 and 116 of [revised Directive 2001/83/EC], the active substances or medicinal products concerned and the issue being addressed, any public hearings pursuant to that procedure and information on how to submit information and to participate in public hearings; | (h) the initiation of the procedure provided for in Articles 114, 115 and 116 of [revised Directive 2001/83/EC], the active substances or medicinal products concerned and the issue being addressed, any public hearings pursuant to that procedure and information on how to submit information and to participate in public hearings; |
| Text proposed by the Commission | Amendment |
|---|---|
| (i) conclusions of assessments, recommendations, opinions, approvals and decisions taken by the Agency and its Committees under this Regulation and [revised Directive 2001/83/EC], unless it is required that this information is made public by the Agency by other means; | (i) conclusions of assessments, obligations for post-marketing studies, recommendations, opinions, approvals and decisions taken by the Agency and its Committees under this Regulation and [revised Directive 2001/83/EC]. |
| Text proposed by the Commission | Amendment |
|---|---|
| (j) conclusions of assessments, recommendations, opinions, approvals and decisions taken by the coordination group, the competent authorities of the Member States and the Commission in the framework of the procedures set out in Articles 16, 106, 107 and 108 of this Regulation and of Chapter IX, Sections 3 and 7 of [revised Directive 2001/83/EC]. | (j) conclusions of assessments, recommendations, opinions, approvals, obligations deriving from the conditional marketing authorisation and decisions taken by the coordination group, the competent authorities of the Member States and the Commission in the framework of the procedures set out in Articles 16, 106, 107 and 108 of this Regulation and of Chapter IX, Sections 3 and 7 of [revised Directive 2001/83/EC]. |
In order to ensure complete transparency and scrutiny, information relating to the obligations deriving from the conditional marketing authorisation shall be made public not only in the summary of product characteristics and in the package leaflet (Article 19), but also on the web portal managed by the Agency. All information concerning terms and conditions shall also be made public.
| Text proposed by the Commission | Amendment |
|---|---|
| The summaries referred to in point (c) shall include a description of any additional risk minimisation measures. | The risk management plans referred to in point (c) shall include a description of any additional risk minimisation measures and distribution/implementation plans. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. In the development and review of the web portal, the Agency shall consult relevant stakeholders, including patient and consumer groups, healthcare professionals and industry representatives. | 2. In the development and review of the web portal, the Agency shall consult relevant stakeholders, including patient and consumer groups, healthcare professionals, non-profit research entities and industry representatives. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a register of environmental risk assessment studies conducted for the purpose of supporting an environmental risk assessment for medicinal products authorised in the Union, unless such information is made public in the Union by different means. | The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a register of environmental risk assessment studies conducted for the purpose of supporting an environmental risk assessment for medicinal products authorised in the Union. |
It is very important that there is a one stop shop for those studies to avoid duplication of research
| Text proposed by the Commission | Amendment |
|---|---|
| Information in such register shall be publicly available, unless restrictions are necessary to protect commercially confidential information. For the purpose of setting up such register, the Agency may request marketing authorisation holders and competent authorities to submit results of any such study already completed for products authorised in the Union within [OP please add the date = 24 months after the date of application of this Regulation]. | Information in such register shall be publicly available and includes as a minimum the information reported in Annex II - Section 1.6 of [revised Directive 2001/83/EC], unless restrictions are necessary to protect commercially confidential information. For the purpose of setting up such register, the Agency may request marketing authorisation holders and competent authorities to submit results of any such study already completed for products authorised in the Union within [OP please add the date = 24 months after the date of application of this Regulation]. |
| Text proposed by the Commission | Amendment |
|---|---|
| Information in such register shall be publicly available, unless restrictions are necessary to protect commercially confidential information. For the purpose of setting up such register, the Agency may request marketing authorisation holders and competent authorities to submit results of any such study already completed for products authorised in the Union within [OP please add the date = 24 months after the date of application of this Regulation]. | Information in the register shall be publicly available . For the purpose of setting up such register, the Agency shall request marketing authorisation holders and competent authorities to submit results of any such study already completed for products authorised in the Union within [OP please add the date = 24 months after the date of application of this Regulation]. |
Aarhus convention should be an overriding force here and all environment-related data must be made publicly available
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Agency and the European Monitoring Centre for Drugs and Drug Addiction shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs. | 2. The Agency and the European Drugs Agency shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union. | The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems, including those that record adverse events including medication errors, processes and standards for medication safety, and implement digital technologies in healthcare settings, capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union. | The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems, including those that record adverse events including medication errors, processes and standards for medication safety, and implement digital technologies in healthcare settings, capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union. | The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems, including those that record adverse events including medication errors, processes and standards for medication safety, and implement digital technologies in healthcare settings, capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union. |
To close gaps in the current EU pharmacovigilance policy and legislation tackling the downstream determinants of harm to better protect the health of European citizens from medication hazards in healthcare settings is required
| Text proposed by the Commission | Amendment |
|---|---|
| The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union. | The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems, including those that record adverse reactions including medication errors, processes and standards for medication safety, and implement digital technologies, with a view to achieve high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union. | The Agency and the Member States shall cooperate to continuously develop pharmacovigilance systems, and implement digital technologies in healthcare proceedings, capable of achieving high standards of public health protection for all medicinal products, regardless of the routes of marketing authorisation, including the use of collaborative approaches, to maximise use of resources available within the Union. |
| Text proposed by the Commission | Amendment |
|---|---|
| Medicinal products subject to additional monitoring. | |
| 1.The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring.That list shall include the names and active substances of: | |
| (a) medicinal products authorised in the Union that contain a new active substance which was not contained in any medicinal product authorised in the Union; | |
| (b) any biological medicinal product not covered by point (a) that was authorised after [date of implementation]; | |
| (c) medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (f) of Article 12(4), point (a) of Article 20(1) or Articles 18, 19, 30 or 113; | |
| (d) medicinal products authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (b) and (c) of Article 44(1), Article 45 or point (a) of the first subparagraph of Article 87(1) thereof. | |
| At the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in points (d), (e) or (g) of Article 12(4), point (b) of Article 20(1) or Article 46(2), may also be included in the list referred to in paragraph 1 of this Article.At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (a), (d), (e) or (f) of Article 44(1), point (b) of Article 87(1) or Article 100(2) thereof may also be included in the list referred to in paragraph 1 of this Article. | |
| 2.The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan. | |
| 3.In the cases referred to in points (a) and (b) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in Article 108(5) of [revised Directive 2001/83/EC].In the cases referred to in points (c) and (d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been fulfilled. | |
| 4.For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement ‘This medicinal product is subject to additional monitoring’.That statement shall be preceded by an inverted black triangle and followed by a standardised explanatory sentence. | |
| 5. The Agency, in cooperation with the competent authorities, shall develop and carry out awareness-raising campaigns on the promotion of information on medicinal products subject to additional monitoring. These campaigns shall aim to raise awareness among healthcare professionals, patients, consumers and the general public about the pharmacovigilance system and the additional monitoring of medicinal products. |
La modificación propuesta mantiene los requisitos relativos a los medicamentos sometidos a vigilancia adicional reflejados en el artículo 23 del Reglamento n.º 726/2004. También incluye la necesidad de mantener el triángulo negro invertido en consonancia con el Reglamento de Ejecución (UE) nº 198/2013 de la Comisión, de 7 de marzo de 2013, relativo a la selección de un símbolo a efectos de identificación de los medicamentos de uso humano sujetos a seguimiento adicional.La legislación revisada debe mantener el concepto de "seguimiento adicional", ya que puede ayudar a identificar mejor los posibles efectos secundarios de los medicamentos aprobados recientemente y a aplicar medidas de mitigación de riesgos. Asimismo, los prospectos deben incluir el símbolo del triángulo negro invertido, fácil de identificar y acompañado de una nota que explique el concepto de seguimiento adicional de forma sencilla pero al mismo tiempo suficientemente exhaustiva.En la enmienda se propone mantener el ámbito actual de los "medicamentos sometidos a un seguimiento adicional", ya que incluye las sustancias activas nuevas, los productos biológicos, los medicamentos aprobados mediante sistemas de acceso temprano y los medicamentos para los que existen obligaciones específicas de seguridad post comercialización.
| Text proposed by the Commission | Amendment |
|---|---|
| Medicinal products subject to additional surveillance | |
| 1.The Agency, in cooperation with the Member States, shall establish, maintain and make public a list of medicinal products subject to additional monitoring. | |
| That list shall include the names and active substances of: | |
| (a) medicinal products authorised in the Union containing a new active substance not contained in any medicinal product authorised in the Union; | |
| (b) any biological medicinal product not referred to in point (a) authorised after [date of application]; | |
| (c) medicinal products authorised under this Regulation, under the conditions laid down in Article 12, paragraph 4, point f), Article 20, paragraph 1, point a), or Articles 18, 19, 30 or 113. | |
| (d) medicinal products authorized under [Directive 2001/83/EC as revised] under the conditions referred to in Article 44, first paragraph b) and c) or in Article 45 or a) of the first paragraph of Article 87 thereof. | |
| At the request of the Commission, after consulting the Pharmacovigilance Risk Assessment Committee, medicinal products authorized under this Regulation under the conditions referred to in Article 12, paragraph d), e) or g), Article 20.1 b) or 46.2 may also be included in the list referred to in paragraph 1 of this Article.At the request of a competent national authority, after consulting the Pharmacovigilance Risk Assessment Committee, medicinal products authorised under [Directive 2001/83/EC revised] under the conditions referred to in the first paragraph of Article 44 a), d) or f), in the first subparagraph of Article 87 b), or in paragraph 2 of Article 100, may also be included in the list referred to in paragraph 1 of this Article. | |
| 2.The list referred to in paragraph 1 shall include an electronic link to the product information and the summary of the risk management plan. | |
| 3.In the cases referred to in paragraphs a) and b) of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in paragraph 5 of Article 108 of [Revised Directive 2001/83/EC] In the cases referred to in points c) and d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been met. | |
| 4.For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement "This medicinal product is subject to additional monitoring".The declaration shall be preceded by an inverted black triangle and followed by a standard explanatory phrase. | |
| 5. The Agency, in cooperation with the competent authorities, shall develop and carry out awareness-raising campaigns on the promotion of information on medicinal products subject to additional monitoring. These campaigns shall aim to raise awareness among healthcare professionals, patients, consumers and the general public about the pharmacovigilance system and the additional monitoring of medicinal products |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 112a | |
| Medicines under additional monitoring | |
| 1. The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. | |
| That list shall include the names and active substances of: | |
| (a) medicinal products authorised in the Union that contain a new active substance which was not contained in any medicinal product authorised in the Union; | |
| (b) any biological medicinal product not covered by point | |
| (a) that was authorised after [date of implementation]; | |
| (c) medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (f) of Article 12(4), point (a) of Article 20(1) or Articles 18, 19, 30 or 113. | |
| (d) medicinal products that are authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (b) and (c) of the first paragraph of Article 44, Article 45, or point (a) of the first subparagraph of Article 87(1) thereof. | |
| (e) medicinal products undergoing the safety-related referrals described in this Regulation and in [revised Directive 2001/83/EC]. | |
| At the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation subject to the conditions referred to in points (d), (e) or (g) of Article 12(4), point (b) of Article 20 (1) or Article 46(2), may also be included in the list referred to in paragraph 1 of this Article. | |
| At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to [revised Directive 2001/83/EC] subject to the conditions referred to in points (a), (d) or (f) of the first paragraph of Article 44, point (b) of the first subparagraph of Article 87 or Article 100(2) thereof, may also be included in the list referred to in paragraph 1 of this Article. | |
| 2. The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan. | |
| 3. In the cases referred to in points (a) and (b) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in Article 108(5) of [revised Directive 2001/83/EC]. | |
| In the cases referred to in points (c) and (d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been fulfilled. | |
| In the cases referred to in point (e) of paragraph 1 of this Article, the medicinal product shall remain in the list for the duration of the procedure, and thereafter depending on the outcome of the referral. | |
| 4. For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement ‘This medicinal product is subject to additional monitoring’. The statement shall be preceded by a symbol which shall be selected by the Commission, following a recommendation of the Pharmacovigilance Risk Assessment Committee, and shall be followed by a standardised explanatory sentence that is appropriate and easy to understand by users. The Commission and the Agency shall ensure that consumers and patients are consulted in this process. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 112a | |
| Medicinal products subject to additional monitoring | |
| 1. The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. That list shall include the names and active substances of: | |
| medicinal products authorised in the Union that contain a new active substance which, was not contained in any medicinal product authorised in the Union. | |
| (b) any biological medicinal product not covered by point (a) that was authorised after [date of implementation]; | |
| (c) medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (f) of Article 12(4), point (a) of Article 20(1) or Articles 18, 19, 30 or 113; | |
| (d) medicinal products authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (b) and (c) of Article 44(1), Article 45 or point (a) of the first subparagraph of Article 87(1) thereof. | |
| At the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in points (d), (e) or (g) of Article 12(4), point (b) of Article 20(1) or Article 46(2), may also be included in the list referred to in paragraph 1 of this Article. | |
| At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (a), (d) or (f) of Article 44(1), point (b) of Article 87(1) or Article 100(2) thereof, may also be included in the list referred to in paragraph 1 of this Article. 2. | |
| The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan. | |
| 3. In the cases referred to in points (a) and (b) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in Article 108(5) of [revised Directive 2001/83/EC]. In the cases referred to in points (c) and (d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been fulfilled. 4. For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement ‘This medicinal product is subject to additional monitoring’. | |
| That statement shall be preceded by an inverted black triangle and followed by a standardised explanatory sentence. | |
| 5. The Agency, in cooperation with the competent authorities, shall develop and carry out awareness-raising campaigns on the promotion of information on medicinal products subject to additional monitoring. These campaigns shall aim to raise awareness among healthcare professionals, patients, consumers and the general public about the pharmacovigilance system and the additional monitoring of medicinal products. |
This article is equivalent to Article 23 of existing Regulation No 726/2004. Only paragraph (5) is new.
| Text proposed by the Commission | Amendment |
|---|---|
| IX REGULATORY SANDBOX | IX deleted |
As drafted it seems like a "carte blanche"; questionable if this is needed as we previously had ATMPs and other products marketed without this tool; in addition, Article 28 of the Directive could be used as an avenue to put non-traditional products on the market, hence sandboxes here are not needed
| Text proposed by the Commission | Amendment |
|---|---|
| [...] | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) it is not possible to develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product; | (a) it is not possible to develop the medicinal product, even if medical devices or in-vitro diagnostic are used as combined products, or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product; |
The regulatory sandboxes' scope of application must be as wide as possible so as to favour technological developments, including improvements to drug-device combination products.
Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen
| Text proposed by the Commission | Amendment |
|---|---|
| (a) it is not possible to develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product; | (a) it is not possible to adequately develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) it is not possible to develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product; | (a) it is not possible to adequately develop the medicinal product or category of products in compliance with the requirements applicable to such medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) it is not possible to develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product; | (a) it is not possible to adequately develop the medicinal product or category of products in compliance with the requirements applicable to such medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) it is not possible to develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product; | (a) it is not possible to satisfactorily develop the medicinal product or category of products in compliance with the requirements applicable to such products due to scientific or regulatory challenges arising from characteristics or methods related to the product; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) it is not possible to develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product; | (a) it is not possible to effectively develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1 a. The creation of a regulatory sandbox is intended to fulfill the following objectives: | |
| a) enabling competent authorities to offer advice to potential marketing authorization applicants to ensure adherence to this Regulation, or other pertinent EU legislation as applicable: | |
| b) assisting prospective marketing authorization applicants in the experimentation and advancement of innovative medicinal products or product categories; | |
| c) facilitating regulatory learning within a managed setting. |
| Text proposed by the Commission | Amendment |
|---|---|
| The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114. | The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 or other relevant Union legislation under the conditions set out in Article 114. By [OP please insert the date = 12 months after the date of entering into force of this Regulation], the Commission shall make an assessment of other relevant Union legislation, and where appropriate draw up a list for which this Article shall apply. |
| Text proposed by the Commission | Amendment |
|---|---|
| The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114. | The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 or other applicable Union legislation under the conditions set out in Article 114. By [OP please insert the date =18 months after the date of entering into force of this Regulation], the Commission shall draw up a list of applicable Union legislation for the application of this Article. |
| Text proposed by the Commission | Amendment |
|---|---|
| The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114. | The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114, while balancing innovation in regulatory procedures with patient safety. |
| Text proposed by the Commission | Amendment |
|---|---|
| The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114. | The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114, while balancing patient safety and innovation in regulatory process. |
| Text proposed by the Commission | Amendment |
|---|---|
| The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114. | The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 and other applicable Union legislation under the conditions set out in Article 114. |
| Text proposed by the Commission | Amendment |
|---|---|
| The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114. | The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and other applicable Union legislation under the conditions set out in Article 114. |
| Text proposed by the Commission | Amendment |
|---|---|
| The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114. | The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and other applicable Union legislation under the conditions set out in Article 114. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions. | 3. The Agency shall monitor the field of emerging medicinal products and shall request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and shall engage with them in preliminary discussions, where relevant by invoking the mechanism of consultation of Article 162. The Agency may set up consultation mechanism with other Union and non-Union regulatory agencies to facilitate its monitoring. The Agency shall draw up and regularly update a list of emerging medicinal or health products for which a regulatory sandbox may be established. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions. | 3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions. The Agency may establish a dialogue framework with regulatory bodies both within and outside the Union to aid in its oversight role. Additionally, the Agency is tasked with creating and routinely revising a roster of nascent medicinal or health products that could be considered for a regulatory sandbox environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions. | 3. The Agency shall monitor the field of emerging medicinal products and shall request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and shall engage with them in preliminary discussions. The Agency may set up consultation mechanism with other Union and non-Union regulatory agencies to facilitate its monitoring. The Agency shall draw up and regularly update a list of emerging medicinal or health products for which a regulatory sandbox may be established. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions. | 3. The Agency shall monitor the field of emerging medicinal products and shall request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and shall engage with them in preliminary discussions, where appropriate referring to the consultation mechanism provided in Article 162. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions. | 3. The Agency shall monitor the field of emerging medicinal products and shall request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and shall engage with them in preliminary discussions, where relevant by invoking the mechanism of consultation of Article 162. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions. | 3. Taking into account HTA expertise, the Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and may engage with them in preliminary discussions. | 3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and shall engage with them in preliminary discussions. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3 a. The regulatory sandbox may also cover the exploration and application of medical devices, in-vitro diagnostics, in silico methods, AI and machine learning technologies in the developement, manifacturing, quality control, and administration of medicinal products, as their use can significanlty add to the efficiency, safety, and effectiveness of the life cycle of medicinal products. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. | Where the Agency considers it appropriate to set up a regulatory sandbox for products which might be regulated as medicinal products (including advanced therapy medicinal products), medical devices, in-vitro diagnostics, substances of human origin, , it shall provide a recommendation to the Commission, where relevant after invoking the mechanism of consultation of Article 162. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. | Where the Agency considers it appropriate to set up a regulatory sandbox for products which might be regulated as medicinal products (including advanced therapy medicinal products), medical devices, in-vitro diagnostics, substances of human origin, it shall provide a recommendation to the Commission, where relevant after invoking the mechanism of consultation of Article 162. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. | Where the Agency considers it appropriate to set up a regulatory sandbox for products, which might be regulated as medicinal products (including advanced therapy medicines), medical equipment, in-vitro diagnostics, substances of human origin, it shall provide a recommendation to the Commission, where appropriate after invoking the consultation mechanism of Article 162. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. | Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which may be classified as a medicinal product or other categories of products falling under the scope of legislation referred to in paragraph 1, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. | Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products (inlcuding ATMPs), or medical devices and other technologies, which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. | Where the Committee on Human Medicinal Products considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. | Where the Agency considers it appropriate to set up a regulatory sandbox for products which are likely to fall under the scope of this Regulation or other relevant Union legislation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products which are likely to fall under the scope of this Regulation, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. | Where the Agency considers it appropriate to set up a regulatory sandbox for medicinal products, medical devices and in-vitro diagnostics, it shall provide a recommendation to the Commission. The Agency shall list eligible products or category of products in that recommendation and shall include the sandbox plan referred to in paragraph 1. |
The regulatory sandboxes are restricted to pharmaceuticals, yet today's innovative products often merge with medical devices, diagnostics, and digital tools, each under distinct regulations. An expanded scope will keep the sandbox relevant and effective in addressing the regulatory needs of these integrated solutions.
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. | 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations including, where relevant, with academia, HTA bodies, patients and their caregivers, healthcare professionals, sponsors, or developers. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and other relevant Union legislation that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. | 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations, by where relevant, HTA bodies, healthcare professionals, patients and their caregivers, and other relevant stakeholders. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. |
Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. | 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations, including, where relevant, of HTA bodies, patients and their caregivers, clinicians, sponsors, developers and academia. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. | 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations including, where relevant, HTA bodies, patients and their caregivers, clinicians, sponsors, developers and academia . The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. | 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] , Regulation (EC) 1394/2007 and other applicable Union legislation that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. | 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and other applicable Union legislation that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. | 5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and other applicable Union legislation that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Commission shall, by means of implementing acts, take a decision on the set up of a regulatory sandbox taking into account the recommendation of the Agency and the sandbox plan pursuant to paragraph 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). | 6. The Commission shall, by means of delegated acts, take a decision on the set up of a regulatory sandbox taking into account the recommendation of the Agency and the sandbox plan pursuant to paragraph 4. Those delegated acts shall be adopted in accordance with the examination procedure referred to in Article 175. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) include as part of the sandbox plan the requirements of this Regulation and of [revised Directive 2001/83/EC] that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment. | (c) include as part of the sandbox plan the requirements of this Regulation of [revised Directive 2001/83/EC], of Regulation (EC) 1394/2007 and of other applicable Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) include as part of the sandbox plan the requirements of this Regulation and of [revised Directive 2001/83/EC] that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment. | (c) include as part of the sandbox plan the requirements of this Regulation, [revised Directive 2001/83/EC], of Regulation (EC) 1394/2007 and of other applicable Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) include as part of the sandbox plan the requirements of this Regulation and of [revised Directive 2001/83/EC] that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment. | (c) include as part of the sandbox plan the requirements of this Regulation, and of [revised Directive 2001/83/EC], and other applicable Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) include as part of the sandbox plan the requirements of this Regulation and of [revised Directive 2001/83/EC] that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment. | (c) include as part of the sandbox plan the requirements of this Regulation, of [revised Directive 2001/83/EC] and other applicable Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) include as part of the sandbox plan the requirements of this Regulation and of [revised Directive 2001/83/EC] that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment. | (c) include as part of the sandbox plan the requirements of this Regulation, of [revised Directive 2001/83/EC] or of other relevant Union legislation that cannot be complied with and shall include appropriate measures to mitigate potential risks to health and to the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may, by means of implementing acts, suspend or revoke a regulatory sandbox at any time. in any of the following cases: | The Commission may, by means of delegated acts, suspend or revoke a regulatory sandbox at any time. in any of the following cases: |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) it is appropriate to protect public health. | (b) it is appropriate to protect public health or the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). | Those delegated acts shall be adopted in accordance with the examination procedure referred to in Article 175. |
| Text proposed by the Commission | Amendment |
|---|---|
| 9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoption of supplementary conditions, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). | 9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by adapting the applicable requirements and conditions laid down in paragraphs 6 and 7, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| 9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoption of supplementary conditions, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). | 9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by adapting the applicable requirements and conditions laid down in paragraphs 6 and 7, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| 9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoption of supplementary conditions, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). | 9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated adapting the relevant requirements and conditions set out in paragraphs 6 and 7, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| 9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoption of supplementary conditions, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. The Commission may also prolong the duration of a regulatory sandbox by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). | 9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoption of supplementary conditions, the Commission may, after consultation of the Agency, amend its decision by means of delegated acts. The Commission may also prolong the duration of a regulatory sandbox by means of delegated acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 175. |
| Text proposed by the Commission | Amendment |
|---|---|
| 10. This Article shall not exclude the setting up of time limited pilot projects to test different ways of implementing the applicable legislation. | 10. This Article shall not exclude the setting up of time limited pilot projects to test different ways of implementing the applicable legislation through delegated acts. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 114 | deleted |
| Products developed under a sandbox | |
| 1. When authorising a clinical trial application for products covered by a regulatory sandbox, Member States shall take the sandbox plan referred to in Article 113(1) into consideration. | |
| 2. A medicinal product developed as part of a regulatory sandbox may be placed on the market only when authorised in accordance with this Regulation. The initial validity of such authorisation shall not exceed the duration of the regulatory sandbox. The authorisation may be prolonged at the request of the marketing authorisation holder. | |
| 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. | |
| 4. For medicinal products developed as part of a regulatory sandbox for which a marketing authorisation has been granted in accordance with paragraph 2 and where appropriate paragraph 3, the summary of product characteristics and the package leaflet shall indicate that the medicinal product has been developed as part of a regulatory sandbox. | |
| 5. Without prejudice to Article 195 of [revised Directive 2001/83/EC], the Commission shall suspend a marketing authorisation granted in accordance with paragraph 2, where the regulatory sandbox has been suspended or revoked in accordance with Article 113(7). | |
| 6. The Commission shall immediately vary the marketing authorisation to take account of the mitigation measures taken in accordance with Article 115. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. | 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. Derogations that could compromise patient safety or run contrary to ethical principles in medicine shall not be granted. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. | 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and of other applicable Union legislation. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. | 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation,[revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and of other applicable Union legislation. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. | 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC], Regulation (EC) 1394/2007 and other relevant Union legislation . These derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. | 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation, [revised Directive 2001/83/EC] and other applicable Union legislation . Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. | 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC], and Regulation (EC) 1394/2007. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 115 | deleted |
| General sandbox provisions | |
| 1. | |
| The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2). | |
| Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without delay until an effective mitigation takes place. | |
| 2. Participants in the regulatory sandbox, in particular the marketing authorisation holder of the medicinal product concerned, shall remain liable under applicable Union and Member States liability legislation for any harm inflicted on third parties as a result from the testing taking place in the sandbox. They shall inform the Agency without undue delay of any information which might entail the amendment of the regulatory sandbox or concerns the quality, safety or efficacy of products developed as part of a regulatory sandbox. | |
| 3. The modalities and the conditions of the operation of the regulatory sandboxes, including the eligibility criteria and the procedure for the application, selection, participation and exiting from the sandbox, and the rights and obligations of the participants shall be set out in implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). | |
| 4. The Agency with input from Member States shall submit annual reports to the Commission on the results from the implementation of a regulatory sandbox, including good practices, lessons learnt and recommendations on their setup and, where relevant, on the application of this Regulation and other Union legal acts supervised within the sandbox. These reports shall be made publicly available by the Commission. | |
| 5. The Commission shall review the reports and put forward, as appropriate, legislative proposals with a view to update the regulatory framework referred to in Article 113(2) or delegated acts in accordance with Article 28 of [revised Directive 2001/83/EC]. |
| Text proposed by the Commission | Amendment |
|---|---|
| The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2). | The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or environment or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2). | The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to stop or restrict their use and inform the Commission in accordance with Article 113(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2). | The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to stop or restrict their use and inform the Commission in accordance with Article 113(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2). | The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to end or restrict their use and inform the Commission in accordance with Article 113(2). |
| Text proposed by the Commission | Amendment |
|---|---|
| Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without delay until an effective mitigation takes place. | Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without any delay until an effective mitigation takes place. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without delay until an effective mitigation takes place. | Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without any delay until an effective mitigation takes place. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The marketing authorisation holder of a medicinal product in possession of a centralised marketing authorisation or a national marketing authorisation (‘the marketing authorisation holder’) shall notify the competent authority of the Member State where the medicinal product has been placed on the market and, in addition, the Agency for a medicinal product covered by a centralised marketing authorisation (these are referred to in this Chapter as ‘the competent authority concerned’) of the following: | 1. The marketing authorisation holder of a medicinal product in possession of a centralised marketing authorisation or a national marketing authorisation (‘the marketing authorisation holder’) shall notify and explain the reasons for the competent authority of the Member State where the medicinal product has been placed on the market and, in addition, the Agency for a medicinal product covered by a centralised marketing authorisation (these are referred to in this Chapter as ‘the competent authority concerned’) of the following: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than twelve months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; | (a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than four months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than twelve months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; | (a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than six months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than twelve months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; | (a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than six months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than twelve months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; | (b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than four months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than twelve months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; | (b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than six months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; |
| Text proposed by the Commission | Amendment |
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| (b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than twelve months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; | (b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than six months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than six months before the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; | (c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than three months before, and in all cases at the earliest possible time, the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder, unless such suspension is triggered by a relevant competent authority; |
| Text proposed by the Commission | Amendment |
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| (c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than six months before the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; | (c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than two months before the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than six months before the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; | (c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than two months before the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder; |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder immediately as soon as they become aware of such temporary disruption which may include substantial concerns about the possibility of a temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
Most shortages would be preventable six months ahead. Marketing authorisation holders should report the a shortage as soon as they become aware of it which may include alerts in the case of substantial concerns regarding the possible disruption in supply.
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than two months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption. The temporary disruption in supply of a medicinal product for which another pack size of that same product is available shall not need to be notified. The Agency shall make available the information to the concerned Member State, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than two months before the start of such temporary disruption of supply, four months if the medicinal product is on the Union list of critical medicinal products established by Article 131 or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than two months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than two months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than two months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than two months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than three months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than three months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder and of the public authorities no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
Pharmaceutical companies' demand forecasts should not be the only warning sign of an expected shortage. Often, pharmaceutical companies use internal forecasts to show that they are ready to change demand. It is a fact that nobody can check such internal documents and determine their quality.
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected and forecasted duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State based on the demand forecast of the marketing authorisation holder and, where available, of national competent authorities in the Union, no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). | (d) a temporary disruption in supply of a medicinal product in a given Member State, based on the demand forecast of the marketing authorisation holder and public authorities, where available, no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| 1 a. The marketing authorisation holder of a medicinal product in possession of a centralised marketing or a national marketing authorisation shall notify the Agency of a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than three months before the start of such temporary disruption of supply or, if this is not possible, as soon as they become aware of such temporary disruption.The temporary disruption in supply of a medicinal product for which another pack size of that same product is available shall not need to be notified. | |
| The Agency shall make available the information to the concerned Member States to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Commission is empowered to adopt delegated acts, in accordance with Article 175 in order to amend Annex IV as regards the information to be provided in case of a temporary disruption of supply, information to be provided in case of a suspension or cessation of marketing of a medicinal product or withdrawal of the marketing authorisation of a medicinal product, or the content of the shortage prevention plan referred to in Article 117. | 3. The Commission is empowered to adopt delegated acts, after consultation with marketing authorisation holders and other relevant stakeholders, and in accordance with Article 175 in order to amend Annex IV as regards the information to be provided in case of a temporary disruption of supply, information to be provided in case of a suspension or cessation of marketing of a medicinal product or withdrawal of the marketing authorisation of a medicinal product, or the content of the shortage prevention plan referred to in Article 117. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2. | 1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2. |
| The marketing authorisation holder shall submit the prevention plan of a critical medicinal product with the concerned competent authority, following paragraph 9 of Article 127. In addition, and following the provisions of paragraph 1 of Article 132, the prevention plans of those medicinal products included in the Union list of critical medicinal products shall be shared with the Agency. The marketing authorisation holder shall comply with any binding recommendations issued by the competent authority of the Member State and by the MSSG, and take in due consideration any other recommendation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2. | 1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2. The shortage prevention plan shall be made available to the Agency and the competent authority of the Member State where the medicinal product is placed on the market. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2. | 1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the Union list of critical medicinal products referred to in Article 131. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by determining medicinal products for which a shortage prevention plan shall be maintained and kept up to date, including due to the lack of availability of alternatives. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2. |
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Cite as
European Parliament (2023). “AMENDMENTS 1277 - 1491 - Draft report Laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006”. Text, 21 November 2023. docId ENVI-AM-756136. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/ENVI-AM-756136 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/ENVI-AM-756136 (CC BY 4.0).
BibTeX
@misc{epw-text-envi-am-756136,
author = {{European Parliament}},
title = {{AMENDMENTS 1277 - 1491 - Draft report Laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006}},
year = {2023},
date = {2023-11-21},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/ENVI-AM-756136}},
url = {https://news.eu-parl.st-solutions.dev/texts/ENVI-AM-756136},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId ENVI-AM-756136. Data: EP Open Data API: document record (CC BY 4.0)}
}