Commission Regulation (EC) No 668/2009
of 24 July 2009
implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises
(Text with EEA relevance) (revoked)
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Scope
Article 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Procedure for evaluation and certification
Article 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Site visits
Article 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Combined advanced therapy medicinal products
Article 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Scientific guidelines
Article 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Report
Article 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Regulation revoked (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(q) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)