Changes from plenary report to adopted text

AddedThe Deputy chairperson shall automatically replace the chairperson if they are prevented from attending to their duties.

AddedThe term of office of the chairperson and the deputy chairperson shall be four years. The term of office may be renewed once. If however, their membership of the Management Board ends at any time during their term of office, their term of office shall automatically expire on that date.

Added6. Without prejudice to paragraph 5 and Article 144, points (e) and (g), the Management Board shall take decisions by absolute majority of its members with voting rights.

Added7. The Management Board shall adopt its rules of procedure.

Added8. The Management Board may invite the chairpersons of the scientific committees to attend its meetings, but they shall not have the right to vote.

Added9. The Management Board may invite any person whose opinion may be of interest to attend its meetings as an observer.

Added10. The Management Board shall approve the annual work programme of the Agency programme and forward it to the European Parliament, the Council, the Commission and the Member States.

Added11. The Management Board shall adopt the annual report on the Agency's activities and forward it by 15 June at the latest to the European Parliament, the Council, the Commission, the European Economic and Social Committee, the Court of Auditors and the Member States.

AddedArticle 144 Tasks of the Management Board

AddedThe Management Board shall:

Added(a) give the general orientations for the Agency's activities;

Added(b) adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use (Article 148) and the Committee for Veterinary Medicinal Products (Article 139 of Regulation (EU) 2019/6);

Added(c) adopt procedures for the performance of scientific services regarding medicinal products for human use (Article 152);

Added(d) appoint the Executive Director, and where relevant extend their term of office or remove them from office, in accordance with Article 145;

Added(e) adopt yearly the Agency’s draft single programming document before its submission to the Commission for its opinion, and the Agency's single programming document by a majority of two-thirds of members entitled to vote and in accordance with Article 154;

Added(f) assess and adopt a consolidated annual activity report on the Agency's activities and send it by 1 July each year to the European Parliament, the Council, the Commission and the Court of Auditors. The consolidated annual activity report shall be made public;

Added(g) adopt the annual budget of the Agency by a majority of two-thirds of the members entitled to vote and in accordance with Article 154;

Added(h) adopt the financial rules applicable to the Agency in accordance with Article 155;

Added(i) exercise, with respect to the staff of the Agency, the powers conferred by Regulation No 31 by the Council of the European Economic Community, and Regulation No 11 and by the Council of the European Atomic Energy Community (‘Staff Regulations’ and ‘Conditions of Employment of Other Servants’) on the Appointing Authority and on the Authority Empowered to Conclude a Contract of Employment (‘the appointing authority powers’);

Added(j) adopt implementing rules for giving effect to the Staff Regulations and the Conditions of Employment of Other Servants in accordance with Article 110 of the Staff Regulations;

Added(k) develop contacts with stakeholders and stipulate the conditions applicable as mentioned in Article 163;

Added(l) adopt an anti-fraud strategy, proportionate to risks of fraud taking into account the costs and benefits of the measures to be implemented;

Added(m) ensure adequate follow-up to findings and recommendations stemming from the internal or external audit reports and evaluations, as well as from investigations of the European Anti-fraud Office (‘OLAF’) and the European Public Prosecutor’s Office (‘EPPO’);

Added(n) adopt rules to ensure the availability to the public of information concerning the authorisation or supervision of medicinal products for human use as mentioned in Article 166;

Added(o) adopt an efficiency gains and synergies strategy;

Added(p) adopt a strategy for cooperation with third countries or international organisations;

Added(q) adopt a strategy for the organisational management and internal control systems.

AddedThe Management Board shall adopt, in accordance with Article 110 of the Staff Regulations, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment of Other Servants, delegating relevant appointing authority powers to the Executive Director and defining the conditions under which that delegation of powers can be suspended. The Executive Director shall be authorised to sub-delegate those powers.

AddedWhere exceptional circumstances so require, the Management Board may, by way of a decision, temporarily suspend the delegation of the appointing authority powers to the Executive Director and those sub-delegated by the latter and exercise them itself or delegate them to one of its members or to a staff member other than the Executive Director.

AddedArticle 145 Executive Director

Added1. The Executive Director shall be engaged as a temporary agent of the Agency under Article 2, point (a), of the Conditions of Employment of Other Servants.

Added2. The Executive Director shall be appointed by the Management Board from a list of candidates proposed by the Commission following an open and transparent selection procedure.

AddedFor the purpose of concluding the contract with the Executive Director, the Agency shall be represented by the Chairperson of the Management Board.

AddedBefore appointment, the candidate nominated by the Management Board shall be immediately invited to make a statement to the European Parliament and to answer any questions put by its Members.

Added3. The term of office of the Executive Director shall be five years. By the end of that period the Commission shall undertake an assessment that takes into account an evaluation of the Executive Director's performance and the Agency's future tasks and challenges.

Added4. The Management Board, acting on a proposal from the Commission that takes into account the assessment referred to in paragraph 3, may extend the term of office of the Executive Director once, for no more than five years.

AddedAn Executive Director whose term of office has been extended may not participate in another selection procedure for the same post at the end of the overall period.

Added5. The Executive Director may be removed from office only upon a decision of the Management Board acting on a proposal from the Commission.

Added6. The Management Board shall reach decisions on appointment, extension of the term of office or removal from office of the Executive Director on the basis of a two-thirds majority of its members with voting rights.

Added7. The Executive Director will be assisted by a Deputy Executive Director. If the Executive Director is absent or indisposed, the Deputy Executive Director shall take their place.

Added8. The Executive Director shall manage the Agency. The Executive Director shall be accountable to the Management Board. Without prejudice to the powers of the Commission and of the Management Board, the Executive Director shall be independent in the performance of their duties and shall neither seek nor take instructions from any government or from any other body.

Added9. The Executive Director shall report to the European Parliament on the performance of their tasks when invited to do so. The Council may invite the Executive Director to report on the performance of those tasks.

Added10. The Executive Director shall be the legal representative of the Agency. The Executive Director shall be responsible for:

Added(a) the day-to-day administration of the Agency;

Added(b) implementing decisions adopted by the Management Board;

Added(c) managing all the Agency resources necessary for conducting the activities of the Committees referred to in Article 142, including making available appropriate scientific and technical support to those Committees, and for making available appropriate technical support to the coordination group;

Added(d) ensuring that the time-limits laid down in Union legal acts for the adoption of opinions by the Agency are complied with;

Added(e) ensuring appropriate coordination between the Committees referred to in Article 142 and, where necessary, between those Committees and the coordination group or other working groups of the Agency;

Added(f) the preparation of the draft statement of estimates of the Agency's revenue and expenditure, and execution of its budget;

Added(g) the preparation of the draft single programming document and the submission it to the Management Board after consulting the Commission;

Added(h) implementing the single programming document and report to the Management Board on its implementation;

Added(i) preparing the Agency’s consolidated annual activity report on the Agency's activities and presenting it to the Management Board for assessment and adoption;

Added(j) all staff matters;

Added(k) providing the secretariat for the Management Board;

Added(l) without prejudice to the competences of OLAF and EPPO, protecting the financial interests of the Union by applying preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by recovering amounts wrongly paid and, where appropriate, by imposing effective, proportionate and dissuasive administrative and financial penalties;

Added(m) reporting, on the basis of key performance indicators agreed by the Management board, on the IT infrastructure developed by the Agency by means of implementation of legislation, in term of timing, budgetary compliance and quality.

Added11. Each year the Executive Director shall submit a draft report covering the activities of the Agency in the previous year and a draft work programme for the coming year to the Management Board for approval, making a distinction between the Agency's activities concerning medicinal products for human use, those concerning herbal medicinal products and those concerning veterinary medicinal products.

AddedThe draft report covering the activities of the Agency in the previous year shall include information about the number of applications evaluated by the Agency, the time taken for completion of the evaluation, and the medicinal products for human use and veterinary medicinal products authorised, rejected or withdrawn.

AddedArticle 146 Scientific Committees – General provisions

Added1. The scientific committees shall be responsible for providing the scientific opinions or recommendations of the Agency, each within their own spheres of competence, and shall have the possibility, where necessary of organising public hearings.