Changes from plenary report to adopted text

Added(i) in case of medicinal products for which there is substantiala detailed justification submitted to the Agency as to the grounds of uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with specific attention given to new active substances and therapeutic indications, a post-authorisation obligation to substantiate the clinical benefit; [Am. 108]

RemovedArticle 143 – paragraph 4 a (new): 4a. Representatives from patients' organisations serving as members or alternate members on scientific committees shall be eligible for reimbursement of expenses incurred in the execution of their duties as representatives, financed through the Agency budget, in accordance with the financial rules applicable to the Agency.

Added(j) where appropriate, details of any recommended obligation to conduct additional post-authorisation environmental risk assessment studies, collection of monitoring data or information on use, where concerns about risks to the environment or public health, including antimicrobial resistance need to be further investigated after the medicinal product has been marketed;

RemovedArticle 146 – paragraph 8 – subparagraph 1: The scientific committees and any working parties and scientific advisory groups established in accordance with this Article shall in general matters establish contacts, on an advisory basis, with parties concerned with the use of medicinal products for human use, in particular patient and consumer organisations, including paediatric representatives, and healthcare professionals’ associations. For that purpose working groups of patient and consumer organisations and healthcare professionals’ associations shall be established by the Agency. They shall ensure a fair representation of healthcare professionals, patients and consumers covering a wide range of experience and disease areas, including orphan, paediatric and geriatric diseases and advanced therapy medicinal products, and a broad geographical range.

Added(ja) where appropriate, any justified reasoning for granting marketing authorisation pursuant to Article 18, 19 and 30 of this Regulation; [Am. 109]

RemovedArticle 147 – title: Independence and conflict of interest

Added(k) the text of the labelling and package leaflet, presented in accordance with Chapter VI of [revised Directive 2001/83/EC];

RemovedArticle 147 – paragraph 1 – subparagraph 2: The Agency's code of conduct shall provide for the implementation of this Article.

Added(l) the assessment report as regards the results of the pharmaceutical and non-clinical tests and of the clinical trials, and as regards the risk management system and the pharmacovigilance system for the medicinal product concerned;

RemovedArticle 147 – paragraph 2: 2. Members of the Management Board, members of the committees, rapporteurs and experts who participate in meetings or working groups of the Agency shall declare, at each meeting, any specific interests which could be considered to be prejudicial to their independence or impartiality with respect to the items on the agenda. These declarations shall be made available to the public. Where the Agency decides that a declared interest for a representative constitutes a conflict of interest, that representative shall not take part in any discussions or decision-making, or obtain any information concerning that item of the agenda. Such declarations of representatives and the decision of the Commission shall be recorded in the summary minutes of the meeting.

Added(m) where appropriate, to carry out medicinal product-specific validation studies to replace animal-based control methods with non-animal-based control methods.

RemovedArticle 147 – paragraph 2 a (new): 2a. The Executive Director shall after leaving the service continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits and if intending to engage in an occupational activity, whether gainful or not, within two years of leaving the service shall inform the Management Board for approval. The Management Board shall, in principle, prohibit them, for 12 months after leaving the service, from engaging in lobbying or advocacy vis-à-vis staff of the Union’s institutions, bodies, offices and agencies for their business, clients or employers on matters for which they were responsible during their last three years in the service.

Added(ma) a stewardship and access plan in accordance with Article 17(1), point (a), of [revised Directive 2001/83/EC] and special information requirements in accordance with Article 69 of that Directive for any antimicrobials, as well as any other obligations imposed on the marketing authorisation holder; [Am. 110]

RemovedArticle 147 – paragraph 2 b (new): 2b. Patients, clinical experts and other relevant experts shall declare any financial and other interests relevant to the joint work in which they are due to participate. Such declarations and any actions taken as a result shall be recorded in the summary minutes of the meeting and in the outcome documents of the joint work in question.

Added(mb) where applicable, reasoning as to whether the medicinal product satisfies the criteria of Article 83 of [revised Directive 2001/83/EC] regarding medicinal products addressing an unmet medical need. [Am. 111]

RemovedArticle 147 – paragraph 2 c (new): 2c. The Agency shall make available the rules of procedure, agendas, minutes and the members of the Management Board, committees, working parties and advisory committees on its website.

Added5. When adopting its opinion, the Committee for Medicinal Products for Human Use shall include the criteria for the prescription or use of the medicinal products in accordance with Article 50(1) of [revised Directive 2001/83/EC].

RemovedArticle 150 – title: Scientific working parties, ad hoc working groups and scientific advisory groups

AddedSection 2 Marketing authorisation decisions

RemovedArticle 150 – paragraph 2 – subparagraph 3: The Committee shall establish an ad hoc Environmental Risk Assessment working party and other scientific working parties, as necessary.

AddedArticle 13 Commission decision on the marketing authorisation

RemovedArticle 150 – paragraph 3 – subparagraph 1 – point b a (new): (ba) fulfilment of conflict of interest requirements referred to in Article 147

Added1. Within 12 days of receipt of the opinion of the Committee for Medicinal products for Human Use the Commission shall submit to the Standing Committee on Medicinal Products for Human Use referred to in Article 173(1) a draft of the decision on the application.

RemovedArticle 150 – paragraph 3 a (new): 3a. Representatives of patients, caregivers, clinicians and academia shall be included as members of the working parties as appropriate.

AddedIn duly justified cases, the Commission may return the opinion to the Agency for further consideration.

RemovedArticle 150 – paragraph 5 a (new): 5a. The Agency shall establish the following ad hoc working groups: / (a) an ad hoc working group on advanced therapy medicinal products; / (b) an ad hoc working group on orphan medicinal products; / (c) an ad hoc working group on paediatric medicinal products

AddedWhere a draft decision envisages the granting of a marketing authorisation, it shall include or make reference to the documents referred to in Article 12(4).

RemovedArticle 151 – paragraph 3 – subparagraph 1: Where necessary, for the nomination of other experts the Agency shall publish a call for expression of interest after endorsement by the Management Board of the necessary criteria and fields of expertise, in particular to ensure a high level of public health and animal protection.

AddedWhere a draft decision envisages the granting of a marketing authorisation subject to the conditions referred to in Article 12(4), points (c) to (j), it shall lay down deadlines for the fulfilment of the conditions, where necessary.

RemovedArticle 152 – paragraph 2 – subparagraph 2: The person concerned, or their employer, shall be remunerated in accordance with [a scale of fees to be included in the financial arrangements established by Regulation (EU) 2024/568 of the European Parliament and of the Council1a. / 1a Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95 (OJ L, 2024/568, 14.2.2024, ELI: http://data.europa.eu/eli/reg/2024/568/oj).

AddedWhere the draft decision differs from the opinion of the Agency, the Commission shall provide a detailed explanation of the reasons for the differences and make that information publicly available. [Am. 112]

RemovedArticle 153 – paragraph 1: At the request of the Commission, the Agency shall, in respect of authorised medicinal products for human use, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product for human use provides. The Agency shall, in collaboration with patient organisations and healthcare professionals, draw up guidelines for the determination of added therapeutic value.

AddedThe Commission shall send the draft decision and the accompanying reasoning referred to in the fifth subparagraph to the Member States and the applicant. [Am. 113]

RemovedArticle 154 – paragraph 4: 4. Activities relating to the assessment of marketing authorisation applications, subsequent variations, pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency. This shall not preclude the Agency from charging fees to marketing authorisation holders for performing these activities by the Agency on the condition that its independence is strictly guaranteed in accordance with Article 147.

Added2. The Commission shall, by means of implementing acts, take a final decision within 12 days after obtaining the opinion of the Standing Committee on Medicinal Products for Human Use. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173, paragraphs 2 and 3.

RemovedArticle 162 – paragraph 2: 2. The Agency shall extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders as relevant.

Added3. Where a Member State raises important new questions of a scientific or technical nature that have not been addressed in the opinion delivered by the Agency, the Commission may refer the application back to the Agency for further consideration. In that case, the procedures set out in paragraphs 1 and 2, shall start again upon reception of the reply of the Agency.

RemovedArticle 163 – paragraph 1: The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and the representatives of the industry, consumers and patients and the healthcare professions, including through the Patients’ and Consumers’ Working Party (PCWP), the Healthcare Professionals’ Working Party (HCPWP) and the Industry Standing Group (ISG). These contacts may include the participation of observers in certain aspects of the Agency's work, under conditions determined beforehand by the Management Board, in agreement with the Commission.

Added4. The Agency shall disseminate the documents referred to in Article 12(4), points (a) to (e), and, where relevant, the documents referred to in Article 12(4), points (f) to (mb), together with any deadlines laid down pursuant to paragraph 1, first subparagraph. [Am. 114]

RemovedArticle 164 – paragraph 5: 5. For not-for-profit entities the Commission shall adopt specific provisions clarifying the definitions, establishing waivers, reductions or deferrals of fees, as appropriate, in accordance with the procedure referred to in Article 10 and Article 12 of and Annex V to [revised Regulation (EC) No 297/95].

AddedArticle 14 Withdrawal of a marketing authorisation application

RemovedArticle 165 – paragraph 3 a (new): Sufficient resources shall be allocated to the Agency to ensure appropriate implementation of its transparency obligations and commitments.

AddedIf an applicant withdraws an application for a marketing authorisation submitted to the Agency before an opinion has been given on the application, the applicant shall communicate its reasons for doing so to the Agency. The Agency shall make this information publicly available and shall publish the assessment report, if available, after deletion of all information of a commercially confidential nature.

RemovedArticle 166 – paragraph 1: 1. To support its public health tasks and in particular the evaluation and monitoring medicinal products or the preparation of regulatory decisions and scientific opinions, the Agency may process personal health data, from sources other than clinical trials, including real world data for the purpose of improving the robustness of its scientific assessment or verifying claims of the applicant or marketing authorisation holder in the context of the evaluation or supervision of medicinal product. The Agency shall put in place sufficient, effective and specific technical and organisational measures to safeguard the fundamental rights and interests of data subjects in line with Regulations (EU) 2016/679 and (EU) 2018/1725, including but not limited to clear and targeted data minimisation policies, state-of-the-art anonymisation and pseudonymisation requirements.

AddedArticle 15 Refusal of a centralised marketing authorisation

RemovedArticle 166 – paragraph 1 – subparagraph 1 a (new): Such data shall in particular include personal electronic health data as defined in Regulation (EU) .../... [EHDS Regulation 2022/0140(COD)], data from the Eudravigilance database, clinical data and, where applicable, data from monitoring studies on the use, effectiveness and safety of medicinal products intended for treatment, prevention or the diagnosis of disease, including health data provided by public authorities.

Added1. The marketing authorisation shall be refused if, after verification of the particulars and documentation submitted in accordance with Article 6, the view is taken that:

RemovedArticle 166 – paragraph 2: 2. The Agency may consider and decide upon additional evidence available, independently from the data submitted by the marketing authorisation applicant or marketing authorisation holder. On that basis, the summary of product characteristics shall be updated if the additional evidence has an impact on the benefit-risk balance of a medicinal product. Such update shall only take place after the consultation with the marketing authorisation applicant or marketing authorisation holder concerned. Marketing authorisation applicants and marketing authorisation holders shall have the opportunity to respond within a reasonable timeline set by the Agency. Marketing authorisation applicants and marketing authorisation holders may submit to the Agency questions and shall be offered the opportunity of an explanation to any proposed update to the summary of product characteristics as appropriate. The reasons for the conclusions reached shall be included in the final opinion.

Added(a) the benefit-risk balance of the medicinal product is not favourable;

RemovedArticle 167 – paragraph 2: For the purposes of the first subparagraph, the Agency shall actively take measures to ensure its compliance with a high common level of cybersecurity adopted within Union institutions, bodies, offices and agencies, identify and implement up-to-date cybersecurity best practices for preventing, detecting, mitigating, and responding to cyber attacks.

Added(b) that the applicant has not properly or sufficiently demonstrated the quality, safety or efficacy of the medicinal product;

RemovedArticle 168 – paragraph 1: 1. Unless otherwise provided for in this Regulation and without prejudice to Regulation (EC) No 1049/2001 and Directive (EU) 2019/1937 of the European Parliament and of the Council85 , and existing national provisions on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the commercially confidential information and trade secrets of natural or legal persons in accordance with Directive (EU) 2016/943 of the European Parliament and of the Council86 , including intellectual property rights.

Added(c) its qualitative and quantitative composition is not as declared;

RemovedArticle 169 – paragraph 1 – subparagraph 2 – point b: (b) as regards special categories of personal data, is strictly necessary and subject to appropriate safeguards, which may include pseudonymisation requirements and techniques, data minimisation measures, specific organisational measures and access controls on a ‘need to know’ basis and other appropriate measures, confidentiality requirements, and fundamental rights of data subjects as set out in Regulations (EU) 2016/679 and (EU) 2018/1725.

Added(d) 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 risk mitigation measures proposed by the applicant in accordance with Article 22(3) of [revised Directive 2001/83/EC]; [Am. 115]

RemovedArticle 171 – paragraph 1: 1. By ... [12 months from the date of entry into force of this Regulation], Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

Added(e) particulars or documentation provided by the applicant in accordance with Article 6, paragraphs 1 to 4, are incorrect;

RemovedArticle 172 – paragraph 5 – point b a (new): (ba) the nature, gravity and duration of the infringement and of its consequences, taking into account the scope as well as the number of persons affected and the level of damage suffered by them;

Added(f) the labelling and package leaflet proposed by the applicant are not in accordance with Chapter VI of [revised Directive 2001/83/EC].

RemovedArticle 172 – paragraph 5 – point b b (new): (bb) the size and market share of the entity committing the infringement;