Changes from plenary report to adopted text

Added2. In each of the situations described in paragraph 1, the Commission shall request the opinion of the Agency within a time-limit which it shall determine having regard to the urgency of the matter, in order to examine the reasons advanced. Whenever practicable, the marketing authorisation holder for placing the medicinal product for human use on the market shall be invited to provide oral or written explanations.

Added3. At any stage of the procedure laid down in this Article, following appropriate consultation of the Agency, the Commission may take temporary measures, by means of implementing acts. Those temporary measures shall be applied immediately.

AddedWithout undue delay, the Commission shall, by means of implementing acts, adopt a final decision concerning the measures to be taken in respect of the medicinal product concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

AddedThe Commission may also, pursuant to Article 57, adopt a decision addressed to the Member States.

Added4. Where urgent action is essential to protect public health or the environment, a Member State may, on its own initiative or at the Commission's request, suspend the use in its territory of a medicinal product for human use which has been authorised in accordance with this Regulation.

AddedWhen it does so on its own initiative, it shall inform the Commission and the Agency of the reasons for its action at the latest on the next working day following the suspension. The Agency shall inform the other Member States without delay. The Commission shall immediately initiate the procedure provided for in paragraphs 2 and 3.

Added5. In cases referred to in paragraph 4, the Member State shall ensure that healthcare professionals are rapidly informed of its action and the reasons for the action. Networks set up by professional associations may be used to this effect. The Member States shall inform the Commission and the Agency of actions taken for this purpose.

Added6. The suspensive measures referred to in paragraph 4 may be maintained in force until such time as a final decision has been adopted by the Commission in accordance with paragraph 3.

Added7. The Agency shall, upon request, inform any person concerned of the final decision and make the decision publicly available immediately after it has been taken.

Added8. Where the procedure is initiated as a result of the evaluation of data relating to pharmacovigilance, the opinion of the Agency, in accordance with paragraph 2, shall be adopted by the Committee for Medicinal Products for Human Use on the basis of a recommendation from the Pharmacovigilance Risk Assessment Committee and Article 115(2) of [revised Directive 2001/83/EC] shall apply.

Added9. By way of derogation from paragraphs 1 to 7, where a procedure under Article 95 or Articles 114, 115 and 116 of [revised Directive 2001/83/EC] concerns a range of medicinal products or a therapeutic class, medicinal products that are authorised in accordance with this Regulation and that belong to that range or class shall only be included in the procedure under Article 95, or Articles 114, 115 and 116 of that Directive.

AddedArticle 56 Action on conditional marketing authorisation

AddedWhere the Agency concludes that a holder of a marketing authorisation granted in accordance with Article 19, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, the Agency shall inform the Commission accordingly.

AddedThe Commission shall adopt a decision to vary, suspend or revoke that marketing authorisation in accordance with the procedure set out in Article 13.

AddedWhere the marketing authorisation holder fails to comply with the obligations in the post-authorisation studies laid down in accordance with Article 20, the Commission may adopt a decision to vary, suspend, or revoke that marketing authorisation in accordance with the procedure laid down in Article 13. [Am. 174]

AddedArticle 57 Member State implementation of conditions or restrictions on a Union marketing authorisation

AddedWhen the Committee for Medicinal Products for Human Use in its opinion refers to recommended conditions or restrictions as provided for in Article 12(4), points (d) to (g), the Commission may adopt a decision addressed to the Member States, in accordance with Article 13 for the implementation of those conditions or restrictions.

AddedCHAPTER V PRE-AUTHORISATION REGULATORY SUPPORT

AddedArticle 58 Scientific advice

Added1. Undertakings or, as relevant, not-for-profit entities may request scientific advice as referred to in Article 138(1), second subparagraph, point (p) , from the Agency.

AddedSuch advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC].

Added2. In the preparation of the scientific advice referred to in paragraph 1 and upon request by undertakings or, as relevant, not-for-profit entities that requested the scientific advice, the Agency may consult experts of the Member States with clinical trial or medical device expertise or the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745.

Added3. In the preparation of the scientific advice referred to in paragraph 1 and in duly justified cases,of this Article the Agency may consult authorities established in other Union legal acts as relevant for the provision of the scientific advice in question or, other public bodies established in the Union, in particular those listed in Article 162 or other bodies, as applicable, or in duly justified cases public bodies established in third countries. [Am. 175]

Added4. The Agency shall include in the European public assessment report the key areas of the scientific advice as well as a detailed log of the pre-submission activities of the medicinal product, including the names of the experts involved, once the corresponding marketing authorisation decision has been taken in relation to the medicinal product, after deletion of any information of a commercially confidential nature. That report shall be made publicly available. [Am. 176]

Added4a. The Agency shall, to the greatest extent possible, ensure that there is a separation between those responsible for providing scientific advice to a given medicinal product developer and those subsequently responsible for the evaluation of the marketing authorisation application for the same medicinal product.

AddedThe Agency shall ensure that at least one of the two rapporteurs for a marketing authorisation application has not taken part in any pre-submission activities concerning the medicinal product. The reasons for any exceptions shall be documented and published with the European public assessment report and recorded in the summary minutes of the meetings in accordance with Article 147(2). [Am. 177]

AddedArticle 59 Parallel scientific advice

Added1. Undertakings or, as relevant, not-for-profit entities established in the Union may request that the scientific advice referred to in Article 58(1) takes place in parallel to the joint scientific consultation carried out by the Member State Coordination Group on Health Technology Assessment, in line with Article 16(5) of Regulation (EU) 2021/2282.

Added2. In case of medicinal products involving a medical device, undertakings or, as relevant, not-for-profit entities may request scientific advice as referred to in Article 58(1) in parallel with the consultation of the expert panels referred to in Article 61(2) of Regulation (EU) 2017/745.

Added3. In the case of paragraph 2, the scientific advice, as referred to in Article 58(1), shall involve exchanges of information between the respective authorities or bodies and, where applicable, have synchronised timing, while preserving the separation of their respective remits.

AddedArticle 60 Enhanced scientific and regulatory support for priority medicinal products (‘PRIME’)

Added1. The Agency may offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products that, based on preliminary evidence submitted by the developer fulfil at least one of the following conditions: [Am. 178]

Added(a) are likely to address an unmet medical need as referred to in Article 83(1) of [revised Directive 2001/83/EC];

Added(b) are orphan medicinal products and are likely to address a high unmet medical need as referred to in Article 70(1);

Added(c) are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation, taking into account the early stage of development, or antimicrobials with any of the characteristics mentioned in Article 40(3) or provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level. [Am. 179]

Added2. The Agency, at the request of the Commission and after consulting the EMA Emergency Task Force, may offer enhanced scientific and regulatory support to developers of a medicinal product preventing, diagnosing or treating a disease resulting from serious cross border threats to health if access to such products is considered necessary to ensure high level of Union preparedness and response to health threats.

Added3. The Agency may stop the enhanced support if it is established that the medicinal product will not address the identified unmet medical need to the anticipated extent.

Added4. The compliance of a medicinal product with the criteria set out in Article 83 of [revised Directive 2001/83/EC] shall be assessed on the basis of the relevant criteria, independently of whether it has received priority medicinal product support under this Article.

Added4a. Where a priority medicinal product benefits from enhanced scientific and regulatory support from the Agency, the European public assessment report shall include a specific section on the Agency’s pre-submission activities, and information on the key areas of the scientific advice and regulatory support provided and on the follow-up by the requester, including corresponding information and data which show that the conditions for the application of the PRIME scheme have been fulfilled. [Am. 180]

AddedArticle 61 Scientific recommendation on regulatory status

Added1. For products under development which may fall within the categories of medicinal products to be authorised by the Union listed in Annex I, a developer or a competent authority of the Member States may submit a duly substantiated request to the Agency for a scientific recommendation with a view to determining on scientific grounds whether the concerned product is potentially a ‘medicinal product’, including an ‘advanced therapy medicinal product’ as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council. The Agency may rely on the relevant expertise of working parties and pools of experts when making its recommendation. [Am. 181]

AddedThe Agency shall deliver its recommendation within 60 days of receiving such a request, which shall be extended by an additional 30 days where a consultation in accordance with paragraph 2 is required.

Added2. When forming the recommendation referred to in paragraph 1, the Agency shall consult, where appropriate and where there is a doubt as to the regulatory status of a product under development, relevant advisory or regulatory bodies established in other Union legal acts in related fields. In the case of products which are based on substances of human origin, the Agency shall first consult the compendium referred to in Regulation (EU) 2024/1938 and where necessary, conduct joint meetings with the Substances of Human Origin (SoHO) Coordination Board as established in that Regulation (EU) No [reference to be added after adoption cf. COM(2022)338 final]. [Am. 182]

AddedThe advisory or regulatory bodies consulted shall reply to the consultation within 30 days of receipt of the request.

AddedThe Agency shall publish summaries of the recommendations delivered in accordance with paragraph 1, after deletion of all information of a commercially confidential nature. [Am. 183]

AddedFor transparency purposes, the respective opinions and conclusions of the Agency and the relevant advisory bodies on the regulatory status of the product shall be made publicly available after the consultations and, where applicable, the joint meetings have taken place. [Am. 184]

AddedArticle 62 Decision on regulatory status

Added1. In the case of duly substantiated disagreement with the Agency’s scientific recommendation, in accordance with Article 61(2), a Member State may request the Commission to decide whether the product is a product referred to in Article 61(1). [Am. 185]

AddedThe Commission may initiate the procedure referred to in the first subparagraph on its own initiative.

Added2. The Commission may ask the Agency and the relevant advisory or regulatory bodies involved in the delivery of the scientific recommendation for clarifications or refer the recommendation back to the Agency for further consideration where a Member State's substantiated request raises new questions of a scientific or technical nature or on its own initiative. [Am. 186]

Added3. The decision of the Commission referred to in paragraph 1 shall be adopted by means of implementing acts, in accordance with the examination procedure referred to in Article 173(2), taking into account the scientific recommendation of the Agency and other advisory bodies. [Am. 187]

AddedCHAPTER VI ORPHAN MEDICINAL PRODUCTS

AddedArticle 63 Criteria for orphan designation

Added1. A medicinal product that is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition shall be designated as an orphan medicinal product where the orphan medicine sponsor can demonstrate that the following requirements are met:

Added(a) the condition affects not more than five in 10 000 persons in the Union when the application for an orphan designation is submitted;

Added(b) there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Union or, where such method exists, that the medicinal product would be of significant benefit to those affected by that condition.

Added2. By way of derogation from paragraph 1, point (a), and on the basis of a recommendation from the Agency, when the requirements specified in paragraph 1, point (a), are not appropriate due to the specific characteristics of certain conditions or any other scientific reasons, the Commission is empowered to adopt delegated acts in accordance with Article 175 in order to supplement paragraph 1, point (a), by setting specific criteria for certain conditions. [Am. 188]

Added3. The Commission shall adopt the necessary provisions for implementing this Article by means of implementing acts in accordance with the procedure laid down in Article 173(2) in order to further specify the requirements referred to in paragraph 1.

AddedArticle 64 Granting an orphan designation

Added1. The orphan medicine sponsor shall submit an application for the designation of the orphan medicinal product to the Agency at any stage of the development of the medicinal product before the application for marketing authorisation referred to in Articles 5 and 6 is submitted.