Changes from plenary report to adopted text

Added5. The Agency shall make documents discussed in working parties accessible to all competent authorities of the Member States.

Added5a. The Agency shall establish the following ad hoc working groups:

Added(a) an ad hoc working group on advanced therapy medicinal products;

Added(b) an ad hoc working group on orphan medicinal products;

Added(c) an ad hoc working group on paediatric medicinal products. [Am. 332]

Added6. When establishing working parties and scientific advisory groups, the scientific committees shall in their rules of procedures provide for:

Added(a) the appointment of members of these working parties and scientific advisory groups on the basis of the lists of experts referred to in Article 151(2); and

Added(b) consultation of these working parties and scientific advisory groups.

AddedArticle 151 Scientific experts

Added1. The Agency or any of the committees referred to in Article 142 may use the services of experts and service providers for the discharge of specific tasks for which they are responsible.

Added2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products for human use and veterinary medicinal products who, taking into account conflicts of interest pursuant to Article 147, would be available to serve on working parties or scientific advisory groups of any of the committees referred to in Article 142, together with an indication of their qualifications and specific areas of expertise.

Added3. Where necessary, for the nomination of other experts the Agency mayshall 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. [Am. 333]

AddedThe Management Board shall adopt the appropriate procedures on a proposal from the Executive Director.

Added4. The Agency shall establish and maintain a pool of accredited experts. That expert pool shall include the national experts referred to in paragraph 2 and any other experts appointed by the Agency or the Commission, and shall be updated.

Added5. Accredited experts shall have access to training provided by the Agency, as appropriate.

Added6. Rapporteurs of any of the committees referred to in Article 142 may use the services of accredited experts for the fulfilment of their tasks in accordance with Article 152. Any remuneration of such accredited expert shall be deducted from the remuneration due to the rapporteurs.

Added7. The remuneration of experts and service providers for services used by the Agency under paragraph 1 shall be financed through the Agency’s budget, in accordance with the financial rules applicable to the Agency.

AddedArticle 152 Rapporteurship

Added1. Where, in accordance with this Regulation, any of the Committees referred to in Article 142 is required to evaluate a medicinal product for human use, it shall appoint one of its members to act as rapporteur, taking into account existing expertise in the Member State. The Committee concerned may appoint a second member to act as co-rapporteur.

AddedA member of a Committee shall not be appointed rapporteur for a particular case if they declare, in accordance with Article 147 any interest that might be, or might be perceived as, prejudicial to the impartial assessment of that case. The Committee concerned may replace the rapporteur or co-rapporteur by another member at any time, if they are unable to fulfil their duties within the prescribed time limits, or if an actual or potential prejudicial interest is detected.

AddedA rapporteur appointed for that purpose by the Pharmacovigilance Risk Assessment Committee shall closely collaborate with the rapporteur appointed by the Committee for Medicinal Products for Human Use or the Reference Member State for the medicinal product for human use concerned.

AddedWhen consulting the scientific advisory groups referred to in Article 150, the Committee shall forward to them the draft assessment report or reports drawn up by the rapporteur or the co-rapporteur. The opinion issued by the scientific advisory group shall be forwarded to the chairperson of the relevant committee in such a way as to ensure that the deadlines laid down in Article 6 are met.

AddedThe substance of the opinion shall be included in the assessment report published pursuant to Article 16(3).

Added2. Without prejudice to Article 151(7), the provision of services by rapporteurs or experts shall be governed by a written contract between the Agency and the person concerned, or where appropriate between the Agency and its employer.

AddedThe person concerned, or their employer, shall be remunerated in accordance with [a scale of fees to be included in the financial arrangements established by the Management Board/mechanism under the new fee legislation]Regulation (EU) 2024/568 of the European Parliament and of the Council. [Am. 334]

AddedThe first and second subparagraphs shall also apply:

Added(a) to the services provided by the chairpersons of the scientific committees of the Agency; and

Added(b) to the work of rapporteurs in the coordination group as regards the fulfilment of its tasks in accordance with Articles 108, 110, 112, 116 and 121 of [revised Directive 2001/83/EC].

AddedArticle 153 Methods to determine added therapeutic value

AddedAt 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. [Am. 335]

AddedSection 3 Financial provisions

AddedArticle 154 Adoption of the budget of the Agency

Added1. Estimates of all the revenue and expenditure of the Agency shall be prepared for each financial year, corresponding to the calendar year, and shall be shown in the budget of the Agency.

Added2. The revenue and expenditure shown in the budget shall be in balance.

Added3. The Agency’s revenue shall consist of:

Added(a) a contribution from the Union;

Added(b) a contribution from third countries participating in the work of the Agency with which the Union has concluded international agreements for that purpose;

Added(c) fees paid by undertakings and entities not engaged in an economic activity:

Added(i) for obtaining and maintaining Union marketing authorisations for medicinal products for human use and for veterinary medicinal products and for other services provided by the Agency, as provided for in this Regulation and in Regulation (EU) 2019/6; and

Added(ii) for services provided by the coordination group as regards the fulfilment of its tasks in accordance with Articles 108, 110, 112, 116 and 121 of [revised Directive 2001/83/EC];

Added(d) charges for other services provided by the Agency;

Added(e) Union funding in the form of grants for participation in research and assistance projects, in accordance with the Agency’s financial rules referred to in Article 155(11) and with the provisions of the relevant instruments supporting the policies of the Union.

AddedThe European Parliament and the Council (‘the budgetary authority’) shall re-examine, when necessary, the level of the Union contribution, referred to in the first subparagraph, point (a), on the basis of an evaluation of needs and by taking account of the level of revenue provided by the sources referred to in the first subparagraph, points (c), (d) and (e).

Added4. 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. [Am. 336]

Added5. The expenditure of the Agency shall include staff remuneration, administrative and infrastructure costs, and operational expenditure. In respect of operational expenditure, budgetary commitments for actions which extend over more than one financial year may be broken down over several years into annual instalments, as necessary.

AddedThe Agency may award grants related to the fulfilment of the tasks incumbent upon it under this Regulation or other relevant Union legal acts or related to the fulfilment of other entrusted tasks.

Added6. Each year the Management Board, on the basis of a draft drawn up by the Executive Director, shall produce an estimate of revenue and expenditure for the Agency for the following financial year. That estimate, which shall include a draft establishment plan, shall be forwarded by the Management Board to the Commission by 31 March at the latest.

Added7. The estimate shall be forwarded by the Commission to the budgetary authority together with the preliminary draft general budget of the European Union.

Added8. On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty.

Added9. The budgetary authority shall authorise the appropriations for the subsidy to the Agency.

AddedThe budgetary authority shall adopt the establishment plan for the Agency.

Added10. The budget shall be adopted by the Management Board. It shall become final following final adoption of the general budget of the European Union. Where appropriate, it shall be adjusted accordingly.

Added11. Any modification of the establishment plan and of the budget shall be the subject of an amending budget, which is forwarded for the purposes of information to the budgetary authority.

Added12. The Management Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which may have significant financial implications for the funding of its budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof.

AddedWhere a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.

AddedArticle 155 Implementation of the Agency’s budget

Added1. The Executive Director shall implement the budget of the Agency in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council.

Added2. By 1 March of financial year n+1, the Agency’s accounting officer shall send the provisional accounts for year n to the Commission’s accounting officer and to the Court of Auditors.

Added3. By 31 March of financial year n+1, the Executive Director shall send the report on the budgetary and financial management for year n to the European Parliament, to the Council, to the Commission and to the Court of Auditors.

Added4. By 31 March of financial year n+1, the Commission’s accounting officer shall send the Agency’s provisional accounts for year n, consolidated with the Commission’s provisional accounts, to the Court of Auditors.