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European Medicines Agency (EMA)
Article 61

Article 61

▼M8
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.

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.

2.
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.

▼B
3.
The members of ►M8 the Committee for Medicinal Products for Human Use may be accompanied by experts in specific scientific or technical fields.
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4.
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.
▼B
5.
In addition to their task of providing objective scientific opinions to the ►M8 Union and Member States on the questions which are referred to them, the members of ►M8 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.
▼M8
6.
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.
7.
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.
▼B
8.
►M8 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.

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