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EC/1394/2007 Regulation 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 (Note: shall apply from 30 December 2008)(Consolidated versi
Short Title:
EC/1394/2007
Origin/Publisher:
European Commission - Enterprise and Industry Directorate General - Consumer Goods - Pharmaceuticals
Document Type:
Regulation
Content:
The scope of this Regulation should be to
regulate advanced therapy medicinal products which are
intended to be placed on the market in Member States and
either prepared industrially or manufactured by a method
involving an industrial process, in accordance with the
general scope of the Community pharmaceutical legislation
laid down in Title II of Directive 2001/83/EC.
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