Thursday, 18 October 2018

EU GMP Annex 2


Annex 2 to EU GMP has recently been updated. This is: “Annex 2 Manufacture of Biological active substances and Medicinal Products for Human Use.” This came into effect on 26th June 2018.

Annex 2 of the GMP Guide has been revised as a consequence of the adoption of the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation (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.

Please note Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which applies the Commission guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products, published in Part IV of Eudralex Volume 4 and operational as of 22 May 2018.


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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