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Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)

Type Regulation

Publication 2004-04-30

Last updated 2022-01-28

State In force

Department Council of the European Union, European Parliament

Source EUR-Lex

articles 85

Reform history JSON API

The Executive Director, in consultation with the Committee for Medicinal Products for Human Use and the Committee for Veterinary Medicinal Products, shall set up the administrative structures and procedures allowing the development of advice for undertakings, as referred to in point (n) of Article 57(1), including advice on the use of novel methodologies and tools in research and development, particularly regarding the development of new therapies.

Those committees shall each establish a standing working party with the sole remit of providing scientific advice to undertakings.

The Committee for Medicinal Products for Human Use and the Committee for Veterinary Medicinal Products may, if they consider it appropriate, seek guidance on important questions of a general scientific or ethical nature.

Article 57

The Agency shall provide the Member States and the institutions of the Union with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human use or veterinary medicinal products which is referred to it in accordance with the Union legislation relating to medicinal products for human use or veterinary medicinal products.

To that end, the Agency, acting particularly through its committees, shall carry out the following tasks:

(a) coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products for human use and of veterinary medicinal products which are subject to Union marketing authorisation procedures;

(b) transmitting on request and making publicly available assessment reports, summaries of product characteristics, labels and package leaflets for the medicinal products for human use;

(c) coordinating the monitoring of medicinal products for human use and of veterinary medicinal products which have been authorised in the Union and providing advice on the measures necessary to ensure the safe and effective use of those products, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation;

(d) ensuring the collation and dissemination of information on suspected adverse reactions to medicinal products for human use and to veterinary medicinal products authorised in the Union by means of databases that are permanently accessible to all Member States;

(e) assisting Member States with the rapid communication of information on pharmacovigilance concerns relating to medicinal products for human use to healthcare professionals and coordinating the safety announcements of the national competent authorities;

(f) distributing appropriate information on pharmacovigilance concerns relating to medicinal products for human use to the general public, in particular by setting up and maintaining a European medicines web-portal;

(i) coordinating, as regards medicinal products for human use and veterinary medicinal products, the verification of compliance with the principles of good manufacturing practice, good laboratory practice, good clinical practice and, as regards medicinal products for human use, the verification of compliance with pharmacovigilance obligations;

(j) upon request, providing technical and scientific support in order to improve cooperation between the Union, its Member States, international organisations and third countries on scientific and technical issues relating to the evaluation of medicinal products for human use and of veterinary medicinal products, in particular in the context of discussions organised in the framework of international conferences on harmonisation;

(k) recording the status of marketing authorisations for medicinal products for human use and for veterinary medicinal products granted in accordance with Union marketing authorisation procedures;

(l) creating a 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 leaflets; 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;

(m) assisting the Union and its Member States in the provision of information to health-care professionals and the general public about medicinal products for human use and about veterinary medicinal products evaluated by the Agency;

(n) advising undertakings on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products for human use and of veterinary medicinal products;

(o) checking that the conditions laid down in Union legislation on medicinal products for human use and on veterinary medicinal products and in the marketing authorisations are met in the case of parallel distribution of medicinal products for human use and of veterinary medicinal products authorised in accordance with this Regulation or, as applicable, Regulation (EU) 2019/6;

(p) drawing up, at the Commission’s request, any other scientific opinion concerning the evaluation of medicinal products for human use and of veterinary medicinal products or the starting materials used in the manufacture of medicinal products for human use and of veterinary medicinal products;

(q) with a view to the protection of public health, compiling scientific information concerning pathogenic agents which might be used in biological warfare, including the existence of vaccines and other medicinal products for human use and other veterinary medicinal products available to prevent or treat the effects of such agents;

(r) coordinating the supervision of the quality of medicinal products for human use and of veterinary medicinal products placed on the market by requesting testing of compliance with their authorised specifications by an Official Medicines Control Laboratory or by a laboratory that a Member State has designated for that purpose;

(s) forwarding annually to the budgetary authority any information relevant to the outcome of the evaluation procedures for medicinal products for human use and veterinary medicinal products;

(t) taking decisions as referred to in Article 7(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council ([^E0006]);

(u) contributing to the joint reporting with the European Food Safety Authority and European Centre for Disease Prevention and Control on the sales and use of antimicrobials in human and veterinary medicine as well as on the situation as regards antimicrobial resistance in the Union based on contributions received by Member States, taking into account the reporting requirements and periodicity in Article 57 of Regulation (EU) 2019/6. Such joint reporting shall be carried out at least every three years.

The database provided for in point (l) of paragraph 1 of this Article shall include the summaries of product characteristics, the package leaflet and the information shown on the labelling. That database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC. The database shall subsequently be extended to include any medicinal product for human use authorised in the Union.

For the purposes of the database, the Agency shall set up and maintain a list of all medicinal products for human use authorised in the Union. To this effect the following measures shall be taken:

(a) the Agency shall, by 2 July 2011 at the latest, make public a format for the electronic submission of information on medicinal products for human use;

(b) marketing authorisation holders shall, by 2 July 2012 at the latest, electronically submit to the Agency information on all medicinal products for human use authorised in the Union, using the format referred to in point (a);

(c) from the date set out in point (b), marketing authorisation holders shall inform the Agency of any new or varied marketing authorisations granted in the Union, using the format referred to in point (a).

Where appropriate, the database shall also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC. The Commission shall, in consultation with the Member States, issue guidelines on data fields which could be included and which may be accessible to the public.

Article 58

The Agency may give a scientific opinion, in the context of cooperation with the World Health Organisation, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Union. For this purpose, an application shall be submitted to the Agency in accordance with the provisions of Article 6. The Committee for Medicinal Products for Human Use may, after consulting the World Health Organisation, draw up a scientific opinion in accordance with Articles 6 to 9. The provisions of Article 10 shall not apply.

The said Committee shall establish specific procedural rules for the implementation of paragraph 1, as well as for the provision of scientific advice.

Article 59

The Agency shall take care to ensure early identification of potential sources of conflict between its scientific opinions and those of other bodies established under Union law carrying out a similar task in relation to issues of common concern.

Where the Agency identifies a potential source of conflict, it shall contact the body concerned in order to ensure that any relevant scientific information is shared and to identify the scientific points which potentially conflict.

Where there is a fundamental conflict over scientific points and the body concerned is a Union agency or a scientific committee, the Agency and the body concerned shall work together either to resolve the conflict or to submit a joint document to the Commission clarifying the scientific points of conflict. This document shall be published immediately after its adoption.

Unless otherwise provided for in this Regulation, Regulation (EU) 2019/6 or Directive 2001/83/EC, where there is a fundamental conflict over scientific points and the body concerned is a body in a Member State, the Agency and the national body concerned shall work together either to resolve the conflict or to prepare a joint document clarifying the scientific points of conflict. Such joint document shall be published immediately after its adoption.

Article 60

At the request of the Commission, the Agency shall, in respect of authorised medicinal products, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product provides.

Article 61

Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human Use.

The alternates shall represent and vote for the members in their absence and may also be appointed to act as rapporteurs in accordance with Article 62.

Members and alternates shall be chosen for their role and experience in the evaluation of medicinal products for human use as appropriate and shall represent the national competent authorities.

The Committee for Medicinal Products for Human Use may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. Those members shall be appointed for a term of three years, which may be renewed, and shall not have alternates.

With a view to the co-opting of such members, the Committee for Medicinal Products for Human Use shall identify the specific complementary scientific competence of the additional member or members. Co-opted members shall be chosen among experts nominated by Member States or the Agency.

The members of the Committee for Medicinal Products for Human Use may be accompanied by experts in specific scientific or technical fields.

The Executive Director of the Agency or his or her representative and representatives of the Commission shall be entitled to attend all meetings of the committees referred to in Article 56(1), working parties and scientific advisory groups and all other meetings convened by the Agency or its committees.

In addition to their task of providing objective scientific opinions to the Union and Member States on the questions which are referred to them, the members of the Committee for Medicinal Products for Human Use shall ensure that there is appropriate coordination between the tasks of the Agency and the work of competent national authorities, including the consultative bodies concerned with the marketing authorisation.

Members of the Committee for Medicinal Products for Human Use and experts responsible for evaluating medicinal products shall rely on the scientific evaluation and resources available to national marketing authorisation bodies. Each competent national authority shall monitor the scientific level and independence of the evaluation carried out and facilitate the activities of nominated members of that Committee and experts. Member States shall refrain from giving those members and experts any instruction which is incompatible with their own individual tasks or with the tasks and responsibilities of the Agency.

When preparing the opinion, the committees referred to in Article 56(1) shall use their best endeavours to reach a scientific consensus. If such a consensus cannot be reached, the opinion shall consist of the position of the majority of members and divergent positions, with the grounds on which they are based.

The Committee for Medicinal Products for Human Use shall establish its own rules of procedure.

These rules shall, in particular, lay down:

(a) procedures for appointing and replacing the Chairman;

(b) procedures relating to working parties and scientific advisory groups; and

(c) a procedure for the urgent adoption of opinions, particularly in relation to the provisions of this Regulation on market surveillance and pharmacovigilance.

They shall enter into force after receiving a favourable opinion from the Commission and the Management Board.

Article 61a

The Pharmacovigilance Risk Assessment Committee shall be composed of the following:

(a) one member and one alternate member appointed by each Member State, in accordance with paragraph 3 of this Article;

(b) six members appointed by the Commission, with a view to ensuring that the relevant expertise is available within the Committee, including clinical pharmacology and pharmacoepidemiology, on the basis of a public call for expressions of interest;

(c) one member and one alternate member appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent healthcare professionals;

(d) one member and one alternate member appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient organisations.

The alternate members shall represent and vote for the members in their absence. The alternate members referred to in point (a) may be appointed to act as rapporteurs in accordance with Article 62.

A Member State may delegate its tasks in the Pharmacovigilance Risk Assessment Committee to another Member State. Each Member State may represent no more than one other Member State.

The members and alternate members of the Pharmacovigilance Risk Assessment Committee shall be appointed on the basis of their relevant expertise in pharmacovigilance matters and risk assessment of medicinal products for human use, in order to guarantee the highest levels of specialist qualifications and a broad spectrum of relevant expertise. For this purpose, Member States shall liaise with the Management Board and the Commission in order to ensure that the final composition of the Committee covers the scientific areas relevant to its tasks.

The members and alternate members of the Pharmacovigilance Risk Assessment Committee shall be appointed for a term of 3 years, which may be prolonged once and thereafter renewed following the procedures referred to in paragraph 1. The Committee shall elect its Chairman from among its members for a term of 3 years, which may be prolonged once.

Paragraphs 3, 4, 6, 7 and 8 of Article 61 shall apply to the Pharmacovigilance Risk Assessment Committee.

The mandate of the Pharmacovigilance Risk Assessment Committee shall cover all aspects of the risk management of the use of medicinal products for human use including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product for human use, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit.

Article 62

Where, in accordance with this Regulation, any of the Committees referred to in Article 56(1) 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.

A rapporteur appointed for this 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.

When consulting the scientific advisory groups referred to in Article 56(2), 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 chairman of the relevant committee in such a way as to ensure that the deadlines laid down in Article 6(3) are met.

The substance of the opinion shall be included in the assessment report published pursuant to Article 13(3).

If there is a request for re-examination of one of its opinions where this possibility is provided for in Union law, the Committee concerned shall appoint a different rapporteur and, where necessary, a different co-rapporteur from those appointed for the initial opinion. The 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 adopted the initial opinion. The applicant may request that the Committee consult a scientific advisory group in connection with the re-examination.

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 Article 63(2), would be available to serve on working parties or scientific advisory groups of any of the committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise.

The Agency shall establish and maintain a list of accredited experts. That list shall include the national experts referred to in the first subparagraph and any other experts appointed by the Agency or the Commission, and shall be updated.

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 his employer.

The person concerned, or his employer, shall be remunerated in accordance with a scale of fees to be included in the financial arrangements established by the Management Board.

The first and second subparagraphs shall also apply to the work of rapporteurs in the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC.

The performance of scientific services for which there are several potential providers may result in a call for an expression of interest, if the scientific and technical context allows, and if it is compatible with the tasks of the Agency, in particular to ensure a high level of public health protection.

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

The Agency or any of the committees referred to in Article 56(1) may use the services of experts for the discharge of other specific tasks for which they are responsible.

Article 63

The membership of the committees referred to in Article 56(1) shall be made public. When each appointment is published, the professional qualifications of each member shall be specified.

Members of the Management Board, members of the committees, rapporteurs and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to this industry shall be entered in a register held by the Agency which is accessible to the public, on request, at the Agency's offices.

The Agency's code of conduct shall provide for the implementation of this Article with particular reference to the acceptance of gifts.

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 with respect to the items on the agenda. These declarations shall be made available to the public.

Article 64

The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and, as appropriate, by other means. Before 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. The mandate of the Executive Director may be renewed once by the Management Board, upon a proposal from the Commission. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his or her post.

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

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

(b) for managing all the Agency resources necessary for conducting the activities of the Committees referred to in Article 56(1), including making available appropriate scientific and technical support to those Committees, and for making available appropriate technical support to the coordination group;

(c) for ensuring that the time-limits laid down in Union legislation for the adoption of opinions by the Agency are complied with;

(d) for ensuring appropriate coordination between the Committees referred to in Article 56(1) and, where necessary, between the Committees and the coordination group;

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

(f) for all staff matters;

(g) for providing the secretariat for the Management Board.

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.

The 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.

Article 65

The Management Board shall consist of one representative of each Member State, two representatives of the Commission and two representatives of the European Parliament.

In addition, two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations 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 within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint the Management Board.

The members of the Management Board shall be appointed in such a way as to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographic spread within the European Union.

The members of the Management Board shall be appointed on the basis of their relevant expertise in management and, if appropriate, experience in the field of medicinal products for human or veterinary use.

Each Member State and the Commission shall appoint their members of the Management Board as well as an alternate who will replace the member in his absence and vote on his behalf.

The term of office of the representatives shall be three years. The term of office may be renewed.

The Management Board shall elect its Chairman from among its members.

The term of office of the Chairman shall be three years and shall expire when he ceases to be a member of the Management Board. The term of office may be renewed once.

Decisions of the Management Board shall be adopted by a majority of two-thirds of its members.

The Management Board shall adopt its rules of procedure.

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

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.

10.

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.

Article 66

The Management Board shall:

(a) adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use (Article 61 of this Regulation) and the Committee for Veterinary Medicinal Products (Article 139 of Regulation (EU) 2019/6);

(b) adopt procedures for the performance of scientific services (Article 62);

(d) adopt the annual work programme and forward it to the European Parliament, the Council, the Commission and the Member States (Article 65);

(e) approve 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 (Article 65);

(f) adopt the budget of the Agency (Article 67);

(g) adopt the internal financial provisions ( Article 68);

(h) adopt provisions implementing the Staff Regulations (Article 75);

(i) develop contacts with stakeholders and stipulate the conditions applicable (Article 78);

(k) adopt rules to ensure the availability to the public of information concerning the authorisation or supervision of medicinal products for human use and of veterinary medicinal products (Article 80).

Chapter 2 Financial Provisions

Article 67

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.

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

The Agency’s revenue shall consist of:

(a) a contribution from the Union;

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

(c) fees paid by undertakings:
(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
(ii) for services provided by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC;

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

(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 68(11) and with the provisions of the relevant instruments supporting the policies of the Union.

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

Activities relating to 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.

The expenditure of the Agency shall include staff remuneration, administrative and infrastructure costs, and operating expenses as well as expenses resulting from contracts entered into with third parties.

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. This estimate, which shall include a draft establishment plan, shall be forwarded by the Management Board to the Commission by 31 March at the latest.

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

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.

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

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

10.

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.

11.

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.

12.

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.

Where 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.

Article 68

The Executive Director shall implement the budget of the Agency in accordance with Regulation (EU) 2018/1046 of the European Parliament and of the Council ([^E0007]) (‘the Financial Regulation’).

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.

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.

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.

On receipt of the Court of Auditors’ observations on the Agency’s provisional accounts pursuant to Article 246 of the Financial Regulation, the Agency’s accounting officer shall draw up the Agency’s final accounts and the Executive Director shall submit them to the Management Board for an opinion.

The Management Board shall deliver an opinion on the Agency’s final accounts for year n.

The Agency’s accounting officer shall, by 1 July of financial year n+1, send the final accounts, together with the Management Board’s opinion, to the European Parliament, to the Council, to the Court of Auditors and to the Commission’s accounting officer.

The final accounts for year n shall be published in the Official Journal of the European Union by 15 November of financial year n+1.

The Executive Director shall send to the Court of Auditors a reply to its observations by 30 September of financial year n+1. The Executive Director shall also send that reply to the Management Board.

The Executive Director shall submit to the European Parliament, at the latter’s request, any information required for the smooth application of the discharge procedure for the financial year concerned, as laid down in Article 261(3) of the Financial Regulation.

10.

The European Parliament, upon a recommendation from the Council, shall, before 15 May of financial year n+2, give a discharge to the Executive Director in respect of the implementation of the budget for year n.

11.

The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They shall not depart from Commission Delegated Regulation (EU) No 1271/2013 ([^E0008]) unless specifically required for the Agency’s operation and with the Commission’s prior consent.

Article 69

In order to combat fraud, corruption and other unlawful activities the provisions of Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) ([^E0009]) shall apply without restriction.

The Agency shall accede to the Interinstitutional Agreement of 25 May 1999 concerning internal investigations by the European Anti-Fraud Office (OLAF) and shall issue, without delay, the appropriate provisions applicable to all the employees of the Agency.

Chapter 3 General Provisions governing the Agency

Article 71

The Agency shall have legal personality. In all Member States it shall enjoy the most extensive legal capacity accorded to legal persons under their laws. It may in particular acquire or dispose of movable and immovable property and may be a party to legal proceedings.

Article 71a

The Agency shall have its seat in Amsterdam, the Netherlands.

The competent authorities of the Netherlands shall take all necessary measures to ensure that the Agency is able to move to its temporary location no later than 1 January 2019 and that it is able to move to its permanent location no later than 16 November 2019.

The competent authorities of the Netherlands shall submit a written report to the European Parliament and the Council on the progress on the adaptations to the temporary premises and on the construction of the permanent building by 17 February 2019, and every three months thereafter, until the Agency has moved to its permanent location.

Article 72

The contractual liability of the Agency shall be governed by the law applicable to the contract in question. The Court of Justice of the European Union shall have jurisdiction pursuant to any arbitration clause contained in a contract concluded by the Agency.

In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by it or by its servants in the performance of their duties.

The Court of Justice shall have jurisdiction in any dispute relating to compensation for any such damage.

The personal liability of its servants towards the Agency shall be governed by the relevant rules applying to the staff of the Agency.

Article 73

Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents ([^E0010]) shall apply to documents held by the Agency.

The Agency shall set up a register pursuant to Article 2(4) of Regulation (EC) No 1049/2001 to make available all documents that are publicly accessible pursuant to this Regulation.

The Management Board shall adopt the arrangements for implementing Regulation (EC) No 1049/2001 within six months of entry into force of this Regulation.

Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may give rise to the lodging of a complaint with the Ombudsman or form the subject of an action before the Court of Justice, under the conditions laid down in Articles 195 and 230 of the Treaty respectively.

Article 73a

Decisions taken by the Agency under Regulation (EC) No 1901/2006 may form the subject of an action before the Court of Justice of the European Union under the conditions laid down in Article 230 of the Treaty.

Article 74

The Protocol on the Privileges and Immunities of the European Union shall apply to the Agency.

Article 75

The staff of the Agency shall be subject to the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the European Union. In respect of its staff, the Agency shall exercise the powers which have been devolved to the appointing authority.

The Management Board, in agreement with the Commission, shall adopt the necessary implementing provisions.

Article 76

Members of the Management Board, members of the committees referred to in Article 56(1), and experts and officials and other servants of the Agency, shall be required, even after their duties have ceased, not to disclose information of the kind covered by the obligation of professional secrecy.

Article 77

The Commission may, in agreement with the Management Board and the relevant committee, invite representatives of international organisations with an interest in the harmonisation of technical requirements applicable to medicinal products for human use and to veterinary medicinal products to participate as observers in the work of the Agency. The conditions for participation shall be determined in advance by the Commission.

Article 78

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 health professions. 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.

The committees referred to in Article 56(1) of this Regulation and any working parties and scientific advisory groups established in accordance with that Article or Article 139(3) of Regulation (EU) 2019/6 shall in general matters establish contacts, on an advisory basis, with parties concerned with the use of medicinal products for human use and of veterinary medicinal products, in particular patient organisations and healthcare professionals’ associations. Rapporteurs appointed by those committees may, on an advisory basis, establish contacts with representatives of patient organisations and healthcare professionals’ associations relevant to the indication of the medicinal product for human use or veterinary medicinal product concerned.

Article 80

To ensure an appropriate level of transparency, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the authorisation or supervision of medicinal products for human use and of veterinary medicinal products which is not of a confidential nature.

The internal rules and procedures of the Agency, its committees and its working groups shall be made available to the public at the Agency and on the Internet.

TITLE V GENERAL AND FINAL PROVISIONS

Article 81

All decisions to grant, refuse, vary, suspend, withdraw or revoke a marketing authorisation which are taken in accordance with this Regulation shall state in detail the reasons on which they are based. Such decisions shall be notified to the party concerned.

An authorisation to place a medicinal product governed by this Regulation on the market shall not be granted, refused, varied, suspended, withdrawn or revoked except through the procedures and on the grounds set out in this Regulation.

Article 82

Only one authorisation may be granted to an applicant for a specific medicinal product.

However, the Commission shall authorise the same applicant to submit more than one application to the Agency for that medicinal product when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or for co-marketing reasons.

As regards medicinal products for human use, Article 98(3) of Directive 2001/83/EC shall apply to medicinal products authorised under this Regulation.

Without prejudice to the unique Union nature of the content of the documents referred to in points (a) to (d) of Article 9(4), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product for human use covered by a single marketing authorisation.

Article 83

By way of exemption from Article 6 of Directive 2001/83/EC Member States may make a medicinal product for human use belonging to the categories referred to in Article 3(1) and (2) of this Regulation available for compassionate use.

For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article 3(1) and (2) available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who can not be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 of this Regulation or must be undergoing clinical trials.

When a Member State makes use of the possibility provided for in paragraph 1 it shall notify the Agency.

When compassionate use is envisaged, the Committee for Medicinal Products for Human Use, after consulting the manufacturer or the applicant, may adopt opinions on the conditions for use, the conditions for distribution and the patients targeted. The opinions shall be updated on a regular basis.

Member States shall take account of any available opinions.

The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4, which shall be published on its website. Article 28(1) and (2) shall apply mutatis mutandis.

The opinions referred to in paragraph 4 shall not affect the civil or criminal liability of the manufacturer or of the applicant for marketing authorisation.

Where a compassionate use programme has been set up, the applicant shall ensure that patients taking part also have access to the new medicinal product during the period between authorisation and placing on the market.

This Article shall be without prejudice to Directive 2001/20/EC and to Article 5 of Directive 2001/83/EC.

Article 84

Without prejudice to the Protocol on the Privileges and Immunities of the European Union, each Member State shall determine the penalties to be applied for infringement of the provisions of this Regulation or the regulations adopted pursuant to it and shall take all measures necessary for their implementation. The penalties shall be effective, proportionate and dissuasive.

Member States shall inform the Commission of these provisions no later than 31 December 2004. They shall notify any subsequent alterations as soon as possible.

Member States shall inform the Commission immediately of any litigation instituted for infringement of this Regulation.

Article 84a

The Commission may impose financial penalties in the form of fines or periodic penalty payments on the holders of marketing authorisations granted under this Regulation if they fail to comply with any of the obligations laid down in Annex II in connection with the marketing authorisations.

The Commission may, insofar as specifically provided for in the delegated acts referred to in point (b) of paragraph 10, impose the financial penalties referred to in paragraph 1 also on a legal entity or legal entities other than the marketing authorisation holder provided that such entities form part of the same economic entity as the marketing authorisation holder and that such other legal entities:

(a) exerted a decisive influence over the marketing authorisation holder; or

(b) were involved in, or could have addressed, such failure to comply with the obligation by the marketing authorisation holder.

Where the Agency or a competent authority of a Member State is of the opinion that a marketing authorisation holder has failed to comply with any of the obligations, as referred to in paragraph 1, it may request the Commission to investigate whether to impose financial penalties pursuant to that paragraph.

In determining whether to impose a financial penalty and in determining its appropriate amount, the Commission shall be guided by the principles of effectiveness, proportionality and dissuasiveness and take into consideration, where relevant, the seriousness and the effects of the failure to comply with the obligations.

For the purposes of paragraph 1, the Commission shall also take into account:

(a) any infringement procedure initiated by a Member State against the same marketing authorisation holder on the basis of the same legal grounds and the same facts; and

(b) any sanctions, including penalties, already imposed on the same marketing authorisation holder on the basis of the same legal grounds and the same facts.

Where the Commission finds that the marketing authorisation holder has failed, intentionally or negligently, to comply with its obligations, as referred to in paragraph 1, it may adopt a decision imposing a fine not exceeding 5 % of the marketing authorisation holder’s Union turnover in the business year preceding the date of that decision.

Where the marketing authorisation holder continues to fail to comply with its obligations referred to in paragraph 1, the Commission may adopt a decision imposing periodic penalty payments per day not exceeding 2,5 % of the marketing authorisation holder’s average daily Union turnover in the business year preceding the date of that decision.

Periodic penalty payments may be imposed for a period running from the date of notification of the relevant Commission's decision until the failure to comply with the obligation by the marketing authorisation holder, as referred to in paragraph 1, has been brought to an end.

When conducting the investigation on a failure to comply with any of the obligations referred to in paragraph 1, the Commission may cooperate with national competent authorities and rely on resources provided by the Agency.

Where the Commission adopts a decision imposing a financial penalty, it shall publish a concise summary of the case, including the names of the marketing authorisation holders involved and the amounts of and reasons for the financial penalties imposed, having regard to the legitimate interest of the marketing authorisation holders for the protection of their business secrets.

The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions whereby the Commission has imposed financial penalties. The Court of Justice of the European Union may cancel, reduce or increase the fine or periodic penalty payment imposed by the Commission.

10.

The Commission is empowered to adopt delegated acts in accordance with Article 87b in order to supplement this Regulation by laying down:

(a) procedures to be applied by the Commission when imposing fines or periodic penalty payments, including rules on the initiation of the procedure, measures of inquiry, rights of the defence, access to file, legal representation and confidentiality;

(b) further detailed rules on the imposition by the Commission of financial penalties on legal entities other than the marketing authorisation holder;

(d) elements to be taken into account by the Commission when setting the level of and imposing fines and periodic penalty payments, as well as the conditions and methods for their collection.

Article 85

This Regulation shall not affect the competences vested in the European Food Safety Authority created by Regulation (EC) No 178/2002 ([^E0011]).

Article 86

At least every 10 years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation and in Chapter 4 of Title III of Directive 2001/83/EC.

Article 86a

By 2019, the Commission shall review the regulatory framework for fees payable to the Agency in relation to medicinal products for human use and veterinary medicinal products. The Commission shall put forward, as appropriate, legislative proposals with a view to update that framework. When reviewing the regulatory framework for fees payable to the Agency, the Commission shall pay attention to potential risks related to the fluctuations in the fee revenue of the Agency.

Article 87

The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use established by Article 121 of Directive 2001/83/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council ([^E0012]).

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Article 87a

In order to harmonise the performance of the pharmacovigilance activities provided for in this Regulation, the Commission shall adopt implementing measures as provided for in Article 108 of Directive 2001/83/EC covering the following areas:

(a) the content and maintenance of the pharmacovigilance system master file kept by the marketing authorisation holder;

(b) the minimum requirements for the quality system for the performance of pharmacovigilance activities by the Agency;

(c) the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;

(d) the minimum requirements for the monitoring of data included in the Eudravigilance database to determine whether there are new risks or whether risks have changed;

(e) the format and content of electronic transmission of suspected adverse reactions by Member States and marketing authorisation holders;

(f) the format and content of electronic periodic safety update reports and risk management plans;

(g) the format of protocols, abstracts and final study reports of the post-authorisation safety studies.

Those measures shall take account of the work on international harmonisation carried out in the area of pharmacovigilance and shall, where necessary, be revised to take account of technical and scientific progress. Those measures shall be adopted in accordance with the regulatory procedure referred to in Article 87(2).

Article 87b

The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

The power to adopt delegated acts referred to in Articles 10b(1), 14-a(9), 16a(3), the second paragraph of Article 16b, and Article 84a(10) shall be conferred on the Commission for a period of five years from 28 January 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

The delegation of power referred to in Articles 10b(1), 14-a(9), 16a(3), the second paragraph of Article 16b, and Article 84a(10) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making ([^E0013]).

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

A delegated act adopted pursuant to Articles 10b(1), 14-a(9), 16a(3), the second paragraph of Article 16b, and Article 84a(10) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.

Article 88

Regulation (EEC) No 2309/93/EC is hereby repealed.

References to the repealed Regulation shall be construed as references to this Regulation.

Article 89

The periods of protection provided for in Articles 14(11) and 39(10) shall not apply to reference medicinal products for which an application for authorisation has been submitted before the date referred to in Article 90, second paragraph.

Article 90

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

By way of derogation from the first paragraph, Titles I, II, III and V shall apply from 20 November 2005 and point 3, fifth and sixth indent of the Annex shall apply from 20 May 2008.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

MEDICINAL PRODUCTS TO BE AUTHORISED BY THE UNION

1. Medicinal products developed by means of one of the following biotechnological processes:

— recombinant DNA technology,

— controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells,

— hybridoma and monoclonal antibody methods.

1a. Advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products ([^E0014])

1. Medicinal products for human use containing a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Union, for which the therapeutic indication is the treatment of any of the following diseases:

— acquired immune deficiency syndrome,

— cancer,

— neurodegenerative disorder,

— diabetes,

— auto-immune diseases and other immune dysfunctions,

— viral diseases.

After 20 May 2008, the Commission, having consulted the Agency, may present any appropriate proposal to amend this point and the European Parliament and the Council shall take a decision thereon in accordance with the Treaty.

1. Medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.

ANNEX II

LIST OF THE OBLIGATIONS REFERRED TO IN ARTICLE 84A

(1) the obligation to submit complete and accurate particulars and documents in an application for marketing authorisation submitted to the Agency or in response to obligations laid down in this Regulation and in Regulation (EC) No 1901/2006 to the extent that the failure to comply with the obligation concerns a material particular;

(2) the obligation to comply with conditions or restrictions included in the marketing authorisation and concerning the supply or use of the medicinal product for human use, as referred to in point (b) of Article 9(4) and in the second subparagraph of Article 10(1);

(3) the obligation to comply with conditions or restrictions included in the marketing authorisation with regard to the safe and effective use of the medicinal product for human use as referred to in points (aa), (c), (ca), (cb) and (cc) of Article 9(4) and in Article 10(1);

(4) the obligation to introduce any necessary variation to the terms of the marketing authorisation to take account of technical and scientific progress and enable the medicinal products for human use to be manufactured and checked by means of generally accepted scientific methods, as provided for in Article 16(1);

(5) the obligation to supply any new information which may entail a variation to the terms of the marketing authorisation, to notify any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product for human use is marketed, or to supply any information that may influence the evaluation of the risks and benefits of the product, as provided for in Article 16(2);

(6) the obligation to keep product information up to date with current scientific knowledge, including the conclusions of the assessment and recommendations made public on the European medicines web-portal, as provided for in Article 16(3);

(7) the obligation to provide, at the request of the Agency, any data demonstrating that the risk-benefit balance remains favourable, as provided for in Article 16(3a);

(8) the obligation to place the medicinal product for human use on the market in accordance with the content of the summary of the product characteristics and the labelling and package leaflet as contained in the marketing authorisation;

(9) the obligation to comply with the conditions referred to in Article 14(8)and Article 14-a;

(10) the obligation to notify the Agency of the dates of actual marketing and of the date when the medicinal product for human use ceases to be on the market, and to provide to the Agency data relating to the volume of sales and the volume of prescriptions of the medicinal product for human use, as provided in Article 13(4);

(11) the obligation to operate a comprehensive pharmacovigilance system for the fulfilment of pharmacovigilance tasks, including the operation of a quality system, maintenance of a pharmacovigilance system master file and performance of regular audits, in accordance with Article 21 of this Regulation in conjunction with Article 104 of Directive 2001/83/EC;

(12) the obligation to submit, at the request of the Agency, a copy of the pharmacovigilance system master file, as provided for in Article 16(3a);

(13) the obligation to operate a risk management system as provided for in Article 14a and Article 21(2) of this Regulation in conjunction with Article 104(3) of Directive 2001/83/EC and Article 34(2) of Regulation (EC) No 1901/2006;

(14) the obligation to record and report suspected adverse reactions for medicinal products for human use, in accordance with Article 28(1) of this Regulation in conjunction with Article 107 of Directive 2001/83/EC;

(15) the obligation to submit periodic safety update reports, in accordance with Article 28(2) of this Regulation in conjunction with Article 107b of Directive 2001/83/EC;

(16) the obligation to conduct post-marketing studies, including post-authorisation safety studies and post-authorisation efficacy studies, and to submit them for review, as provided for in Article 10a of this Regulation and Article 34(2) of Regulation (EC) No 1901/2006;

(17) the obligation to ensure that public announcements relating to information on pharmacovigilance concerns are presented objectively and are not misleading and to notify them to the Agency, as provided for in Article 22 of this Regulation and Article 106a(1) of Directive 2001/83/EC;

(18) the obligation to comply with the time limits for initiating or completing measures specified in the Agency’s decision on deferral following the initial marketing authorisation of the medicinal product for human use concerned and in accordance with the definitive opinion referred to in Article 25(5) of Regulation (EC) No 1901/2006;

(19) the obligation to place the medicinal product for human use on the market within two years of the date on which the paediatric indication is authorised, as provided for in Article 33 of Regulation (EC) No 1901/2006;

(20) the obligation to transfer the marketing authorisation or to allow a third party to use documentation contained in the file of the medicinal product, as provided for in the first paragraph of Article 35 of Regulation (EC) No 1901/2006;

(21) the obligation to submit paediatric studies to the Agency, including the obligation to enter information on third country clinical trials into the European database, as provided for in Articles 41(1) and (2), 45(1) and 46(1) of Regulation (EC) No 1901/2006;

(22) the obligation to submit an annual report to the Agency as provided for in Article 34(4) of Regulation (EC) No 1901/2006 and to inform the Agency in accordance with the second paragraph of Article 35 of that Regulation.

[^E0001]: Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).

[^E0002]: OJ L 117, 8.5.1990, p. 15. Directive repealed by Directive 2001/18/EC, but continues to have certain legal effects.

[^E0006]: Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1).

[^E0007]: Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).

[^E0008]: Commission Delegated Regulation (EU) No 1271/2013 of 30 September 2013 on the framework financial regulation for the bodies referred to in Article 208 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (OJ L 328, 7.12.2013, p. 42).

[^E0009]: OJ L 136, 31.5.1999, p. 1.

[^E0010]: OJ L 145, 31.5.2001, p. 43.

[^E0011]: Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

[^E0012]: Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

[^E0013]: OJ L 123, 12.5.2016, p. 1.

[^E0014]: OJ L 324, 10.12.2007, p. 121.

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