Regulation (EC) No 1394/2007 of the European Parliament and of the CouncilDangos y teitl llawn

Article 23 Tasks of the Committee for Advanced Therapies

The Committee for Advanced Therapies shall have the following tasks:

(a)

to formulate a draft opinion on the quality, safety and efficacy of an advanced therapy medicinal product for final approval by the Committee for Medicinal Products for Human Use and to advise the latter on any data generated in the development of such a product;

(b)

to provide advice, pursuant to Article 17, on whether a product falls within the definition of an advanced therapy medicinal product;

(c)

at the request of the Committee for Medicinal Products for Human Use, to advise on any medicinal product which may require, for the evaluation of its quality, safety or efficacy, expertise in one of the scientific areas referred to in Article 21(2);

(d)

to provide advice on any question related to advanced therapy medicinal products, at the request of the Executive Director of the Agency or the Commission;

(e)

to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of this Regulation;

(f)

at the Commission’s request, to provide scientific expertise and advice for any Community initiative related to the development of innovative medicines and therapies which requires expertise in one of the scientific areas referred to in Article 21(2);

(g)

to contribute to the scientific advice procedures referred to in Article 16 of this Regulation and in Article 57(1)(n) of Regulation (EC) No 726/2004.