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TITLE IVU.K.THE EUROPEAN MEDICINES AGENCY — RESPONSIBILITIES AND ADMINISTRATIVE STRUCTURE

Chapter 1U.K.Tasks of the Agency

Article 55U.K.

A European Medicines Agency is hereby established.

The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.

Article 56U.K.

[F11. The Agency shall comprise:

(a) the Committee for Medicinal Products for Human Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use;

[F2(aa) the Pharmacovigilance Risk Assessment Committee, which shall be responsible for providing recommendations to the Committee for Medicinal Products for Human Use and the coordination group on any question relating to pharmacovigilance activities in respect of medicinal products for human use and on risk management systems and it shall be responsible for monitoring the effectiveness of those risk management systems;]

(b) the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for veterinary use;

(c) the Committee on Orphan Medicinal Products;

(d) the Committee on Herbal Medicinal Products;

[F3(da) the Committee for Advanced Therapies;]

(e) the Paediatric Committee;

[F4(f) a Secretariat, which shall provide technical, scientific and administrative support for the Committees and ensure appropriate coordination between them, and which shall provide technical and administrative support for the coordination group and ensure appropriate coordination between it and the Committees;]

(g) an Executive Director, who shall exercise the responsibilities set out in Article 64;

(h) a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67.]

2.The committees referred to in paragraph [F5paragraph 1(a) to (da)] may each establish standing and temporary working parties. The committees referred to in paragraph paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in Articles 5 and 30.

When establishing working parties and scientific advisory groups, the committees shall in their rules of procedures referred to in Article 61(8) provide for:

(a)the appointment of members of these working parties and scientific advisory groups on the basis of the lists of experts referred to in the second subparagraph of Article 62(2); and

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

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

Each committee shall establish a standing working party with the sole remit of providing scientific advice to undertakings.

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

Textual Amendments

Article 57U.K.

1.The Agency shall provide the Member States and the institutions of the [F6Union with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Union] legislation relating to medicinal products.

To this end, the Agency, acting particularly through its committees, shall undertake the following tasks:

(a)coordination of the scientific evaluation of the quality, safety and efficacy of medicinal products which are subject to [F6Union] marketing authorisation procedures;

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

[F4 [F7(c) coordinating the monitoring of medicinal products which have been authorised within the Union and providing advice on the measures necessary to ensure the safe and effective use of those medicinal 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 authorised in the Union by means of a database which is permanently accessible to all Member States;]

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

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

[F8(g) advising on the maximum limits for residues of veterinary medicinal products and biocidal products used in animal husbandry which may be accepted in foodstuffs of animal origin in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down [F6Union] procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (1) ;]

(h)providing scientific advice on the use of antibiotics in food-producing animals in order to minimise the occurrence of bacterial resistance in the [F6Union]; this advice shall be updated when needed;

(i)coordinating the verification of compliance with the principles of good manufacturing practice, good laboratory practice, good clinical practice and the verification of compliance with pharmacovigilance obligations;

(j)upon request, providing technical and scientific support in order to improve cooperation between the [F6Union], its Member States, international organisations and third countries on scientific and technical issues relating to the evaluation of 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 granted in accordance with [F6Union] procedures;

(l)creating a database on medicinal products, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner;

(m)assisting the [F6Union] and Member States in the provision of information to health-care professionals and the general public about 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;

(o)checking that the conditions laid down in [F6Union] legislation on medicinal products and in the marketing authorisations are observed in the case of parallel distribution of medicinal products authorised in accordance with this Regulation;

(p)drawing up, at the Commission's request, any other scientific opinion concerning the evaluation of medicinal products or the starting materials used in the manufacture of medicinal products;

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

(r)coordination of the supervision of the quality of 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[F1;]

[F9(t) taking decisions as referred to in Article 7(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (2) .]

2.The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The 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 and of Directive 2001/82/EC respectively. The database shall subsequently be extended to include any medicinal product placed on the market within the [F6Union].

[F2For 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;

[F7(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.

Textual Amendments

Article 58U.K.

1.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 [F6Union]. 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.

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

Textual Amendments

Article 59U.K.

1.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 [F6Union] law carrying out a similar task in relation to issues of common concern.

2.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.

3.Where there is a fundamental conflict over scientific points and the body concerned is a [F6Union] 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.

4.Save as otherwise provided in this Regulation, in Directive 2001/83/EC or in Directive 2001/82/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. This document shall be published immediately after its adoption.

Textual Amendments

Article 60U.K.

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 61U.K.

1.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 and one member and one alternate to the Committee for Medicinal Products for Veterinary Use.

The alternates shall represent and vote for the members in their absence and may 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 and veterinary use as appropriate and shall represent the competent national authorities.

2.The committees may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These 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 committees shall identify the specific complementary scientific competence of the additional member(s). Co-opted members shall be chosen among experts nominated by Member States or the Agency.

3.The members of each Committee may be accompanied by experts in specific scientific or technical fields.

4.The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the committees, working parties and scientific advisory groups and all other meetings convened by the Agency or its committees.

5.In addition to their task of providing objective scientific opinions to the [F6Union] and Member States on the questions which are referred to them, the members of each committee 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.

6.Members of the committees 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 committee members and experts. Member States shall refrain from giving committee members and experts any instruction which is incompatible with their own individual tasks or with the tasks and responsibilities of the Agency.

7.When preparing the opinion, each committee shall use its 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.

8.Each committee 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.

Textual Amendments

[F2Article 61a U.K.

1. 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.

2. 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.

3. 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.

4. 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.

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

6. 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.]

Textual Amendments

Article 62U.K.

1.[F4Where, 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(s) 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) and Article 31(3) are met.

The substance of the opinion shall be included in the assessment report published pursuant to Article 13(3) and Article 38(3).

[F4If 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.]

2.[F4Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products for human use 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 keep an up-to-date list of accredited experts. The list shall include the experts referred to in the first subparagraph and other experts appointed directly by the Agency. The list shall be updated.

3.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.

[F2The 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.]

4.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.

5.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.

Textual Amendments

Article 63U.K.

1.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.

2.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 64U.K.

[F61. 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.]

2.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;

[F4(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 [F6Union] legislation for the adoption of opinions by the Agency are complied with;

[F4(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.

3.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.

[F6The 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.]

Textual Amendments

Article 65U.K.

1.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.

2.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.

3.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.

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

5.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.

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

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

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

9.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 66U.K.

The Management Board shall:

(a)

adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use (Article 61);

(b)

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

(c)

appoint the Executive Director (Article 64);

(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 ([F4Article 68]);

(h)

adopt provisions implementing the Staff Regulations (Article 75);

(i)

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

(j)

adopt provisions for providing assistance to pharmaceutical companies (Article 79);

(k)

adopt rules to ensure the availability to the public of information concerning the authorisation or supervision of medicinal products (Article 80).

Textual Amendments

Textual Amendments