Changes from report parliamentary committee draft to plenary report

RemovedArticle 47 – paragraph 1 – point d: deleted

AddedArticle 27 – paragraph 5: 5. If a colour has been removed from the Union list of authorised food additives for reasons that do not require an EFSA opinion, the Commission shall decide on the use of the colour concerned in medicinal products and, where applicable, include it in the list of colours permitted for use in medicinal products referred to in paragraph 3. The Commission shall, in such cases, request the opinion from the Agency.

RemovedArticle 47 – paragraph 1 a (new): 1a. The national marketing authorisation may furthermore be refused if, after verification of the particulars and documentations referred to in Article 6 and subject to the specific requirements laid down in Articles 9 to 14, the view is taken that the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant and the competent authority deems that post-authorisation environmental risk assessment studies in accordance with Article 44(1), point (h), would be an insufficient measure to ensure environmental protection.

AddedArticle 28 – paragraph 6 a (new): 6a. The Commission shall submit a report on the application of adapted frameworks to the European Parliament and to the Council. The first report shall be submitted five years from [OP please insert the date =18 months from the date of entry into force of this Directive] and then every five years thereafter.

RemovedArticle 51 – paragraph 1 – point e: (e) is an antimicrobial of systemic administration;

AddedArticle 29 – paragraph 3: 3. Where the competent authority of the Member State considers that the marketing authorisation application is incomplete, or contains critical deficiencies that may prevent the evaluation of the medicinal product it shall inform the applicant accordingly and shall set a time limit for submitting the missing information and documentation. If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn by default.

RemovedArticle 51 – paragraph 1 – point e a (new): (ea) is an antibiotic; or

AddedArticle 29 – paragraph 4 – subparagraph 2: The competent authority of the Member State shall summarise the deficiencies in writing. On this basis, the competent authority of the Member State shall inform the applicant accordingly and set a reasonable time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the Member State, the application shall be considered as withdrawn by default.

RemovedArticle 56 – paragraph 3 – subparagraph 1: The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors in accordance with Articles 166 and 167, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

AddedArticle 29 – paragraph 4 a (new): 4a. When making public the information on the ERA and the antimicrobial stewardship and access plan referred to in Article 17, the competent authority shall delete any information of a commercially confidential nature.

RemovedArticle 57 – paragraph 1: 1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body of the Union, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

AddedArticle 34 – paragraph 3: 3. The competent authority of the reference Member State for the decentralised procedure shall inform the Coordination group for decentralised and mutual recognition procedures of an application, which shall thereafter notify the competent authorities of all Member States. The competent authority of a Member State may request for justified public health reasons to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

RemovedArticle 57 – paragraph 2 – point a – point ii: (ii) the public authority or publicly funded body of the Union that provided the financial support referred to in point (i);

AddedArticle 34 – paragraph 4 – subparagraph 2: The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawn by default.

RemovedArticle 57 – paragraph 6 a (new): 6a. The Agency shall provide a publicly accessible website to facilitate access to the electronic links communicated to the Agency in accordance with paragraphs 2 and 3, sorted, where relevant, by medicine and by Member State.

AddedArticle 36 – paragraph 4: 4. The competent authority of the reference Member State for the decentralised procedure shall inform the Coordination group for decentralised and mutual recognition procedures of an application, which shall thereafter notify the competent authorities of all Member States. The competent authority of a Member State may request for justified public health reasons to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

RemovedArticle 58 a (new): Article 58a / Obligation to submit an application for pricing and reimbursement in all Member States / 1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, submit in good faith an application for pricing and reimbursement no later than two years from the date when the Member State made its request, or within four years from that date for any of the following entities: / (i) SMEs; / (ii) entities not engaged in an economic activity (‘not-for-profit entity’); and / (iii) undertakings that, by the time of granting the marketing authorisation, have received not more than seven centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. / For the purposes of this Directive and [revised Regulation (EC) No 726/2004], the Commission shall by ... [18 months after the date of entry into force of this Directive] adopt delegated acts in accordance with Article 215 to supplement this Directive by laying down the criteria to qualify as a micro, small and medium-sized enterprise, taking into account the specificities of enterprises of this sector within the Union. / The marketing authorisation holder shall notify that it fulfilled the obligations set out in the first subparagraph through the EU Access to Medicines Notification System provided for …

AddedArticle 37 – paragraph 2 – subparagraph 1: The coordination group shall be composed of one representative per Member State and one representative from patients’ organisations appointed for a renewable period of three years. Alternates may be appointed for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts.

RemovedArticle 58 b (new): Article 58b / EU Access to Medicines Notification System / 1. The Commission shall, in collaboration with the Member States, set up and maintain an electronic notification system (the “EU Access to Medicines Notification System”) as a single-entry point for the notification of compliance with the obligations set out in Article 58a. The EU Access to Medicines Notification System shall be interoperable with the other Union-wide data repositories for medicinal products. / 2. The marketing authorisation holder shall use the EU Access to Medicines Notification System to notify their compliance with the obligations set out in Article 58a. In the Member States where the marketing authorisation is valid, the national competent authority shall use the EU Access to Medicines Notification System to indicate that the marketing authorisation holder has fulfilled its obligations set out in Article 58a. / 3. By ... [3 years following the date of entry into force of this Directive], the Commission shall adopt implementing acts to establish technical and organisational requirements, including on security aspects and data governance, which are necessary for the practical implementation of the EU Access to Medicines Notification System. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). / 4. By ... [5 years after the date of entry into force of this Directive] and every 3 years thereafter, the Commission shall present a report to…

AddedArticle 42 – paragraph 1 – subparagraph 5: The Commission shall send the draft decision to the competent authorities of the Member States and the applicant or the marketing authorisation holder and make the decision, including the justification, publicly available.

RemovedArticle 63 – paragraph 3: 3. Member States may decide that the package leaflet shall be made available electronically, or both in paper format and electronically. In the absence of such specific rules in a Member State, a package leaflet shall be made available electronically and be included in paper format in the packaging of a medicinal product. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients as well as written and designed in a clear and understandable way.

AddedArticle 43 – paragraph 3: 3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet, the antimicrobial stewardship and access plan and special information requirements referred to in Article 17(1), points (a) and (b), as well as any conditions established in accordance with Articles 17, 44, 45 and any obligations imposed subsequently in accordance with Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.

Change 26

ChangedArticle 6343 – paragraph 34: a4. (new):The 3a.competent Ifauthority aof the Member State has decided that the package leafletmay isconsider onlyand todecide beupon madeadditional availableevidence electronically,available, patientsindependently shallfrom bethe madedata awaresubmitted ofby theirthe rightmarketing toauthorisation aholder. printedOn copythat ofbasis, the package leaflet.summary Ifof theproduct packagecharacteristics leafletshall isbe onlyupdated toif bethe madeadditional availableevidence electronically,has aan packageimpact leafleton inthe paperbenefit-risk formatbalance mayof stilla bemedicinal providedproduct. onThe acompetent voluntaryauthority basisshall byinform the marketing authorisation holder inof additionits todecision, including the electronicgrounds packagefor leaflet.that decision, without unnecessary delay.

Change 27

RemovedArticle 63 – paragraph 4 a (new): 4a. Where the medicinal product is not intended to be delivered directly to and administered by the patient, the Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 of this Article by making only the electronic version of the package leaflet mandatory in this specific context. In such a case, a package leaflet in paper format may still be provided on a voluntary basis by the marketing authorisation holder in addition to the electronic package leaflet.

AddedArticle 44 – paragraph 1 – subparagraph 1 – point g: (g) in case of medicinal products for which, on duly justified grounds set out in the assessment report, there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with particular attention to new active substances and therapeutic indications, a post-authorisation obligation to substantiate the clinical benefit;

AddedArticle 47 – paragraph 1 – point d: (d) the environmental risk assessment is incomplete or insufficiently substantiated, and the reason for the incomplete nature of the environmental risk assessment is not duly justified and substantiated by the applicant, or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant or by the risk mitigation measures included by the applicant, in accordance with Article 22(3);

AddedArticle 47 – paragraph 1 – point d a (new): (da) For medicinal products where the reference medicinal product received its first marketing authorisation before 30 October 2005, the national marketing authorisation may be refused if the view is taken that the environmental risk assessment is incomplete or insufficiently substantiated and those medicinal products can be identified as potentially harmful to the environment.

AddedArticle 49 – paragraph 2: 2. If the application complies with all the measures contained in the agreed completed paediatric investigation plan and if the summary of product characteristics reflects the results of studies conducted in compliance with that agreed paediatric investigation plan, the competent authority of the Member State shall include within the marketing authorisation a statement indicating compliance of the application with the agreed completed paediatric investigation plan. The competent authority shall make the conclusions of the assessment regarding compliance with the agreed completed paediatric investigation plan publicly available.

AddedArticle 51 – paragraph 1 – point e: (e) is an antibiotic or any other antimicrobial for which there is an identified risk of antimicrobial resistance; or

AddedArticle 51 – paragraph 1 – point f: (f) contains an active substance, adjuvants or any other ingredients or constituent parts which are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.

AddedArticle 51 – paragraph 1 a (new): 1a. The Commission shall adopt implementing acts to add further antimicrobial products that shall be subject to prescription status where the Agency has identified a risk of antimicrobial resistance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

AddedArticle 51 – paragraph 2: 2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned by authorising the use of pre-cut blister units or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.

AddedArticle 51 – paragraph 2 a (new): 2a. A prescription for antibiotic products shall be subject to the following conditions: / (a) be limited to the amount required for the treatment or therapy concerned; / (b) only be prescribed for a limited duration to cover the period of risk when used as prophylaxis; / (c) in the event that a diagnostic test has not been performed, a justification shall be required.

AddedArticle 51 – paragraph 2 b (new): 2b. Member States shall, wherever possible, provide per unit prescription and dispensing for the treatment or therapy concerned.

AddedArticle 51 – paragraph 4 – point c a (new): (ca) the risk of antimicrobial resistance, including any mitigating measures in that regard, from use of the medicinal product

AddedArticle 51 – paragraph 5 – point b: deleted

AddedArticle 57 – paragraph 1: 1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority, publicly funded body or philanthropic or not-for-profit organisation or fund, irrespective of its geographic location, and any indirect financial support received from any public authority or publicly funded body of the Union or its Member States in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

AddedArticle 57 – paragraph 2 – point a – point ii: (ii) the entity that provided the financial support referred to in point (i);

AddedArticle 57 – paragraph 2 – point a – point iii a (new): (iiia) where relevant, any independent legal entity from which it obtained a licence in relation to, or acquired the medicinal product in its previous phases of development, and at which stage of the research and development process. The marketing authorisation holder shall, to the extent possible, include in the report information on funding received as referred to paragraph 1 specific to the relevant medicinal product.

AddedArticle 57 – paragraph 6: 6. The Commission shall adopt implementing acts to lay down the principles and format for the information to be reported pursuant to paragraph 2, by [12 months from the date of entry into force of this Directive]. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

AddedArticle 57 – paragraph 6 a (new): 6a. The Agency shall provide on its website the links to the information communicated to the Agency in accordance with paragraphs 2 and 3, sorted, where relevant, by medicinal product and by Member State.

AddedArticle 58 a (new): Article58a / Obligation to submit an application for pricing and reimbursement in all Member States / 1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, in good faith and within the limits of its responsibilities, submit an application for pricing and reimbursement for the medicinal product and, where relevant, negotiate. In the case of a positive decision to permit the marketing of the medicinal product in accordance with Directive 89/105/EEC, the obligation in Article 56(3) of this Directive to ensure appropriate and continued supply to cover the needs of patients in that Member State shall apply. The application for pricing and reimbursement for the medicinal product shall be submitted no later than 12 months from the date when the Member State made its request, or within 24 months from that date for any of the following entities: / (i) SMEs; / (ii) entities not engaged in an economic activity (‘not-for-profit entity’); and / (iii) undertakings that, by the time of granting the marketing authorisation, have received not more than five centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. / The deadlines set out in the first subparagraph of this paragraph shall be prolonged by six months following the notification of the m…

AddedArticle 58 b (new): Article58b / EU Access to Medicines Notification System / 1. The Commission shall set up and maintain an electronic notification system for the notification of compliance with the obligations set out in Article 58a (the ‘EU Access to Medicines Notification System’). The EU Access to Medicines Notification System shall be interoperable with other relevant Union-wide data repositories for medicinal products. / 2. The marketing authorisation holder shall use the EU Access to Medicines Notification System to notify their compliance with the obligations set out in Article 58a. In the Member States where the marketing authorisation is valid, the national competent authority shall use the EU Access to Medicines Notification System to indicate that the marketing authorisation holder has fulfilled its obligations set out in Article 58a. / 3. By ... [3 years from the date of entry into force of this Directive], the Commission shall adopt implementing acts to establish technical and organisational requirements. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). / 4. By ... [5 years from the date of entry into force of this Directive], the Commission shall assess the feasibility of extending the EU Access to Medicines Notification System to other areas of the process for pricing of medicinal products as set out in Directive 89/105/EEC and, if appropriate, adopt implementing acts to establish this extended system. Those imp…

AddedArticle 63 – paragraph 3: 3. Member States may decide that for individual medicinal products, categories of medicinal products or for all medicinal products, the package leaflet shall be made available both in paper format and electronically or electronically only. In the latter case, the decision shall be made only following a consultation of patients, carers and other relevant stakeholders. In the absence of such specific rules in a Member State, a package leaflet shall be made available electronically and be included in paper format in the packaging of a medicinal product. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients as well as written and designed in a clear and understandable way.

AddedArticle 63 – paragraph 3 a (new): 3a. If a Member State has decided that the package leaflet is only to be made available electronically, patients shall be made aware of their right to a printed copy of the package leaflet.

AddedArticle 63 – paragraph 3 b (new): 3b. If a Member State decides that the package leaflet shall be made available electronically, a paper package leaflet in addition to the electronic format may be made available on a voluntary basis by the marketing authorisation holder in addition to the electronic package leaflet.

AddedArticle 63 – paragraph 4 a (new): 4a. By way of derogation from paragraph 3, where the medicinal product is intended for dispensation and administration by a qualified healthcare professionals rather than for self-administration by the patient, the package leaflet may be made available only electronically.

Article 63 – paragraph 5: deleted

Change 28

ChangedArticle 63 – paragraph 6: 6. By ... [12 months afterfrom the date of entry into force of this Directive], the Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies.

Change 29

RemovedArticle 63 – paragraph 7: 7. When accessing the package leaflet electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data according to relevant Union legislation, and shall not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes including advertising and marketing activities.

AddedArticle 63 – paragraph 6 a (new): 6a. The Agency shall make available a system to accommodate the electronic product information after consultation with Member States and the relevant stakeholders. The system shall be available at the latest by [24 months from the date of entry into force of this Directive].

RemovedArticle 63 – paragraph 7 a (new): 7a. The Agency shall develop a system providing public access to the electronic version of package leaflets. By ... [12 months after the date of entry into force of this Directive], the system shall be accessible in all Member States.

AddedArticle 63 – paragraph 7: 7. When accessing the package leaflet electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC and shall not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes including for advertising or marketing activities.

Change 30

ChangedArticle 64 – paragraph 3: 3. Following a consultation with target patient groups and other relevant stakeholders, the Commission shall adopt guidelines to ensure that the package leaflet is legible, clear and easy to use as well as on the need for and modalities of further user testing.use.

Change 31

AddedArticle 66 – paragraph 1: 1. The particulars laid down in Annex IV shall appear on immediate packagings other than those referred to in the paragraphs 2 and 3 and shall allow, at the request of the national competent authorities, single dispensation, particularly in the event of a shortage or major public health issue.

AddedArticle 66 – paragraph 2 a (new): 2a. Each single dose of the blister pack shall include the following labelling particulars: / (a) the name of the medicinal product followed by its strength and pharmaceutical form; / (b) a data matrix code in which the following information is encoded: (i) the Global Trading Index Number (GTIN) / (ii) the expiry date; / (iii) the batch number.

Article 67 – paragraph 1 – subparagraph 2: Medicinal products not subject to prescription shall not bear the safety features referred to in Annex IV, unless, by way of exception, they have been listed in accordance with the procedure referred to in paragraph 2, second subparagraph, point (b), or where the marketing authorisation holder chooses to do so voluntarily.

Article 67 – paragraph 7 a (new): 7a. For the purpose of patient safety, Member States may decide that medicinal products imported or distributed in parallel shall be repackaged in new outer packaging.

Change 32

RemovedArticle 69 – paragraph 2 – subparagraph 2: Member States shall ensure that the awareness card is made available in paper format or both in paper format and electronically. In the absence of such specific rules in a Member State, an awareness card in paper format shall be included in the packaging of an antimicrobial.

AddedArticle 69 – paragraph 1: 1. The marketing authorisation holder shall ensure availability of educational material to healthcare professionals, regarding the appropriate use of diagnostic tools, testing or other diagnostic approaches related to antimicrobial-resistant pathogens, that may inform on the use of the antimicrobial. Any informational material shall be compatible with the summary of product characteristics.