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Regulation (EC) No 1394/2007 of the European Parliament and of the CouncilShow full title
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)
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Changes over time for: Article 21
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Article 21U.K.Composition of the Committee for Advanced Therapies
1.The Committee for Advanced Therapies shall be composed of the following members:
(a)five members or co-opted members of the Committee for Medicinal Products for Human Use from five Member States, with alternates either proposed by their respective Member State or, in the case of co-opted members of the Committee for Medicinal Products for Human Use, identified by the latter on the advice of the corresponding co-opted member. These five members with their alternates shall be appointed by the Committee for Medicinal Products for Human Use;
(b)one member and one alternate appointed by each Member State whose national competent authority is not represented among the members and alternates appointed by the Committee for Medicinal Products for Human Use;
(c)two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent clinicians;
(d)two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent patients’ associations.
The alternates shall represent and vote for the members in their absence.
2.All members of the Committee for Advanced Therapies shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products. For the purposes of paragraph 1(b), the Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Committee for Advanced Therapies provides appropriate and balanced coverage of the scientific areas relevant to advanced therapies, including medical devices, tissue engineering, gene therapy, cell therapy, biotechnology, surgery, pharmacovigilance, risk management and ethics.
At least two members and two alternates of the Committee for Advanced Therapies shall have scientific expertise in medical devices.
3.The members of the Committee for Advanced Therapies shall be appointed for a renewable period of three years. At meetings of the Committee for Advanced Therapies, they may be accompanied by experts.
4.The Committee for Advanced Therapies shall elect its Chairman from among its members for a term of three years, renewable once.
5.The names and scientific qualifications of all members shall be made public by the Agency, in particular on the Agency’s website.
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