Changes from plenary report to adopted text

Added2. In case of first-in-class medicinal products or when a novel question is raised during the assessment of the submitted environmental risk assessment, the Committee for Medicinal Products for Human Use, or the rapporteur, shall carry out necessary consultations with bodies Member States have set up in accordance with Directive 2001/18/EC. They mayshall also consult with relevant Union bodies. Details on the consultation procedure shall be published by the Agency at the latest by [OJ:12 months after the date of entry into force of this Regulation]. [Am. 104]

RemovedArticle 130 – paragraph 6 a (new): 6a. Following the request by a Member State to use the Voluntary Solidarity Mechanism referred to in Article 132(1a), the Agency shall provide assistance to the MSSG and may: / (a) confirm that the conditions are met to launch the Voluntary Solidarity Mechanism; / (b) notify the members of the MSSG of the launch of the Voluntary Solidarity Mechanism; / (c) request from the members of the MSSG relevant information within a specific time limit; / (d) put the issuing country in contact with those Member States able to support them; / (e) organise meetings with the issuing Member States, the donating party and other relevant concerned parties; / (f) request the activation of the Union Civil Protection Mechanism to coordinate and logistically support the voluntary transfer of medicinal products.

AddedArticle 10 Committee assessment of an application for marketing authorisation

RemovedArticle 131 – paragraph 1: 1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c), and the Patients’ and Consumers’ Working Party (PCWP), the Healthcare Professionals’ Working Party (HCPWP) and the Industry Standing Group (ISG). Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

Added1. When preparing its opinion, the Committee for Medicinal Products for Human Use shall verify that the particulars and documentation submitted in accordance with Article 6 comply with the requirements of [revised Directive 2001/83/EC], and shall examine whether the conditions specified in this Regulation for granting a marketing authorisation are satisfied. When preparing its opinion, the Committee for Medicinal Products for Human Use may make the following requests:

RemovedArticle 131 – paragraph 2: 2. The MSSG shall propose updates to the Union list of critical medicines to the Commission, where necessary.

Added(a) that an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose tests the medicinal product for human use, its starting materials, ingredients and, where necessary, its intermediate products or other constituents in order to ensure that the control methods employed by the manufacturer and described in the application documents are satisfactory;

RemovedArticle 132 – paragraph 1: 1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may include recommendations on manufacturing capacity, on reorganisation of manufacturing capacity, diversification of suppliers, inventory management, establishment of minimum safety stock and, if necessary, redistribution of available stock among Member States under the Voluntary Solidarity Mechanism to address urgent needs, as well as pricing and procurement mechanisms and measures and, where appropriate, the use of regulatory flexibilities without lowering safety and efficacy standards.

Added(b) that the applicant supplements the particulars accompanying the application within a specific time period. In case of such a request, the time-limit set out in Article 6(6), first subparagraph, shall be suspended until the supplementary information requested is provided. Likewise, this time-limit shall be suspended for the time allowed for the applicant to prepare oral or written explanations.

RemovedArticle 132 – paragraph 1 a (new): 1a. The MSSG shall coordinate the Voluntary Solidarity Mechanism to allow Member States to request assistance in obtaining stocks of a medicinal product during critical shortages. The MSSG shall specify the procedures and criteria to launch the Voluntary Solidarity Mechanism in consultation with the Member States, the Agency and the Commission.

Added2. Where within 90 days of the validation of the marketing authorisation application and during the assessment the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient quality or maturity to complete the assessment, the assessment can be terminated. The Committee for Medicinal Products for Human Use shall summarise the deficiencies in writing. On this basis, the Agency 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 Agency, the application shall be considered as withdrawn by default. [Am. 105]

RemovedArticle 132 – paragraph 1 b (new): 1b. Following the update of the Union list of critical medicinal products, the MSSG shall assess the shortage prevention plan of the medicinal products present on the list.

AddedArticle 11 Certification of manufacturer

RemovedArticle 134 – paragraph 1 – introductory part: 1. The Commission shall:

Added1. Upon receipt of a written request from the Committee for Medicinal Products for Human Use, a Member State shall forward the information demonstrating that the manufacturer of a medicinal product or the importer from a third country is able to manufacture the medicinal product concerned or carry out the necessary control tests, or both in accordance with the particulars and documents supplied by the applicant pursuant to Article 6.

RemovedArticle 134 – paragraph 1 – point -a (new): (-a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating critical shortages of medicinal products;

Added2. The Committee for Medicinal Products for Human Use may, if it considers it necessary in order to complete the assessment, require the applicant to undergo a specific inspection of the manufacturing site of the medicinal product concerned.

RemovedArticle 134 – paragraph 1 – point c a (new): (ca) develop guidelines to ensure that national initiatives on stockpiling are proportionate to the needs and do not create undesirable consequences, such as supply shortages, in other Member States;

AddedThe inspection shall be carried out within the time-limit set out in Article 6(6), first subparagraph, by inspectors from the Member State holding the appropriate qualifications. Those inspectors may be accompanied by a rapporteur or an expert appointed by the Committee, or by one or more inspectors of the Agency. The inspections may be carried out unannounced.

RemovedArticle 134 – paragraph 1 – point c b (new): (cb) develop, within the framework of Directive 2014/24/EU, guidelines to support public procurement practices in the pharmaceutical field, in particular with regard to the implementation of the most economically advantageous tender (MEAT) criteria in order to establish remedies against single-winner, price-only tenders.

AddedFor manufacturing sites located in third countries, the inspection may be carried out by the Agency, following a request by the Member States and based on the procedure set out in Article 52.

RemovedArticle 134 – paragraph 1 a (new): 1a. The Commission shall work with the ECDC on producing reliable forecasts of potential threats and potential shortages.

AddedArticle 12 Committee Opinion

RemovedArticle 134 – paragraph 2: 2. The Commission, taking into consideration the information or the opinion, referred to in paragraph 1, or MSSG recommendations, is empowered to adopt delegated acts in accordance with Article 175 supplementing this Regulation to improve security of supply, while allowing Member States to adopt or maintain legislation ensuring a higher degree of protection against shortages of medicinal products, in respect of the commitments taken in the framework of the Voluntary Solidarity Mechanism. The delegated acts may impose contingency stock requirements of active pharmaceutical ingredient or finished dosage forms, or other relevant measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant entities.

Added1. The Agency shall without undue delay inform the applicant if the opinion of the Committee for Medicinal Products for Human Use is that:

RemovedArticle 134 – paragraph 3: deleted

Added(a) the application does not satisfy the criteria for marketing authorisation set out in this Regulation;

RemovedArticle 138 – paragraph 1 – subparagraph 1: The Agency shall provide the Member States and the institutions of the Union with the best possible scientific opinion on any question relating to the evaluation of the quality, safety, efficacy and environmental risk of medicinal products for human use, veterinary medicinal products, which is referred to it in accordance with the Union legal acts relating to medicinal products for human use or veterinary medicinal products.

Added(b) the application satisfies the criteria set out in this Regulation subject to changes required by the Agency to the summary of product characteristics are made;

RemovedArticle 138 – paragraph 1 – subparagraph 2 – introductory part: The Agency, acting particularly through its Committees and working groups, shall carry out the following tasks:

Added(c) the application satisfies the criteria set out in this Regulation provided that changes required by the Agency, to the labelling or package leaflet of the medicinal product, are made to ensure compliance with Chapter VI of [revised Directive 2001/83/EC];

RemovedArticle 138 – paragraph 1 – subparagraph 2 – point a: (a) coordinating the scientific evaluation of the quality, safety, efficacy and environmental risk of medicinal products for human use, which are subject to Union marketing authorisation procedures;

Added(d) where applicable, the application satisfies the criteria set out in Articles 18 and 19 subject to specific conditions therein.

RemovedArticle 138 – paragraph 1 – subparagraph 2 – point a a (new): (aa) develop, after consulting with relevant national authorities and national bodies responsible for pricing and reimbursement in accordance with Article 162 of this Regulation and the Member State Coordination Group on Health Technology Assessment established by Article 3 of Regulation (EU) 2021/2282, harmonised standards for the design of scientific studies for marketing authorisation holders;

Added2. Within 12 days of receipt of the opinion referred to in paragraph 1, the applicant may request by written notice to the Agency a re-examination of the opinion. In that case, the applicant shall provide the Agency with the detailed grounds for the request within 60 days after receipt of the opinion.

RemovedArticle 138 – paragraph 1 – subparagraph 2 – point b: (b) coordinating the scientific evaluation of the quality, safety and efficacy of veterinary medicinal products, which are subject to Union marketing authorisation procedures in accordance with Regulation (EU) 2019/6 , providing advice on methodological aspects relating to the trials for such products and the use of clinical trial results affected for regulatory purposes and coordinating the performance of other tasks set out in Regulation (EU) 2019/6 and Regulation (EC) 470/2009;

AddedThe re-examination procedure may deal only with the points of the opinion initially identified by the applicant and may be based only on the scientific data available when the Committee for Medicinal Products for Human Use adopted the initial opinion.

RemovedArticle 138 – paragraph 1 – subparagraph 2 – point c: (c) transmitting on request and making publicly available assessment reports, summaries of product characteristics, periodic safety update reports, labels, package leaflets and AMR awareness cards, where applicable, for the medicinal products for human use;

AddedWithin 60 days following receipt of the grounds for the request, the Committee for Medicinal Products for Human Use shall re-examine its opinion. The reasons for the conclusion reached shall be annexed to the final opinion.

RemovedArticle 138 – paragraph 1 – subparagraph 2 – point n: (n) creating a user-friendly database on medicinal products for human use, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database is to facilitate the search for information already authorised for package leaflet, and for other documents deemed relevant by the Agency; it is to include a section on medicinal products for human use authorised for the treatment of children; the information provided to the general public is to be worded in an appropriate and comprehensible manner;

Added3. Within 12 days after its adoption, the Agency shall send the final opinion of the Committee for Medicinal Products for Human Use to the Commission, to the Member States and to the applicant, together with a report describing the assessment of the medicinal product by the Committee for Medicinal Products for Human Use and stating the reasons for its conclusions.

RemovedArticle 138 – paragraph 1 – subparagraph 2 – point zc: (zc) establishing a mechanism of consultation of authorities or bodies active along the life cycle of medicinal products for human use for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency, notably with the SoHO Coordination Board, Medical Devices Coordination Group, the Member State Coordination Group on Health Technology Assessment and national pricing and reimbursement authorities;

Added4. If an opinion is favourable to the granting of the relevant marketing authorisation, the following documents shall be annexed to the opinion:

RemovedArticle 138 – paragraph 1 – subparagraph 2 – point ze: (ze) cooperating with EU decentralised agencies and other scientific authorities and bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, the European Centre for Disease Prevention and Control and the European Environment Agency as regards the scientific assessment of relevant substances, exchange of data and information and development of coherent scientific methodologies, including replacing, reducing or refining animal testing, and, where possible, prioritising replacement strategies such as non-animal in vitro and silico approaches, taking into account the specificities of the assessment of medicinal products;

Added(a) a summary of product characteristics referred to in Article 62 of [revised Directive 2001/83/EC] and corresponding to the assessment of the medicinal product;

RemovedArticle 138 – paragraph 1 – subparagraph 2 – point zl a (new): (zla) where scientific guidelines are provided, the Agency shall ensure that such guidelines are kept up-to-date and based on the latest scientific developments.

Added(b) a recommendation on the frequency of submission of periodic safety update reports;

RemovedArticle 138 – paragraph 2 – subparagraph 1: The database provided for in paragraph 1, point (n), shall include all medicinal products for human use authorised in the Union together with the summaries of product characteristics, European product assessment reports, periodic safety update reports, where applicable documentation related to scientific advice received, environmental risk assessment reports, the package leaflet, the information shown on the labelling, awareness cards in the case of antimicrobials, post-marketing obligations related to the medicinal product, shortage prevention and, where relevant, mitigation plans, and information as to in which Member States the medicinal product is placed on the market and other documents deemed relevant by the Agency. Where relevant, it shall include the electronic links to the dedicated webpages where the marketing authorisation holders have reported the information pursuant to 40(4), point (b) and Article 57 [revised Directive 2001/83/EC].

Added(c) details of any conditions or restrictions to be imposed on the supply or use of the medicinal product concerned, including the conditions under which the medicinal product may be made available to patients, in accordance with the criteria laid down in Chapter XII of [revised Directive 2001/83/EC];

RemovedArticle 138 – paragraph 2 – subparagraph 2 – point b a (new): (ba) marketing authorisation holders shall electronically submit to the Agency information concerning in which Member States the medical products for human use authorised in the Union have been placed on the market.

Added(d) details of any recommended conditions or restrictions with regard to the safe and effective use of the medicinal product;

RemovedArticle 138 – paragraph 2 – subparagraph 3: Where applicable, the database shall also include references to clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 81 of Regulation (EU) No 536/2014.

Added(e) details of any recommended measures for ensuring the safe use of the medicinal product to be included in the risk management system;

RemovedArticle 142 – paragraph 1 – point l: (l) a Secretariat, which shall provide technical, scientific and administrative support to all bodies of the Agency and ensure appropriate coordination between them, and which shall provide technical and administrative support for the coordination group referred to in Article 37 of [revised Directive 2001/83/EC] and ensure appropriate coordination between it and the Committees. It shall also ensure the implementation of all transparency commitments and undertake the work required of the Agency under the procedures for the assessment and preparations of decisions for paediatric investigation plans, waivers, deferrals or orphan designations.

Added(f) where appropriate, details of any recommended obligation to conduct post-authorisation safety studies or to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Chapter VIII;

RemovedArticle 143 – paragraph 1 – subparagraph 2: In addition, two representatives of patients' organisations, one representative of doctors' organisations, one representative of pharmacists’ organisations and one representative of veterinarians' organisations, all with voting rights, shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes appreciably more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and at the latest within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint these representatives to the Management Board.

Added(g) where appropriate, details of any recommended obligation to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed. Such an obligation to conduct such studies shall be based on the delegated acts adopted pursuant to Article 21 while taking into account the scientific guidance referred to in Article 123 of [revised Directive 2001/83/EC] and the consultation process in accordance with Article 162 of this Regulation; [Am. 106]

RemovedArticle 143 – paragraph 2 – subparagraph 2: All parties represented in the Management Board shall make efforts to limit turnover of their representatives, in order to ensure continuity of the work of the Management Board. All parties shall aim to achieve a gender balanced representation on the Management Board.

Added(h) where appropriate, details of any recommended obligation to conduct any other post-authorisation studies, including post-authorisation treatment optimisation studies, to improve the safe and effective use of the medicinal product; [Am. 107]

RemovedArticle 143 – paragraph 4: 4. The term of office for members and their alternates shall be four years. That term shall be extendable once consecutively.