Keyword      Search in       

Contact
Imprint
Site Map

Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

EC/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 (Note: shall apply from 30 December 2008)(Official Journal L 324, 10/12/2007 p. 121 - 137).
Short Title:EC/1394/2007
Internet:http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_2007_1394/reg_2007_1394_en.pdf
Origin/Publisher:European Commission - Enterprise and Industry Directorate General - Consumer Goods - Pharmaceuticals
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.
Document Type:Regulation