On April 19, 2010 the European Commission published the revised draft of GMP
Annex 2: Manufacture of Biological Medicinal Substances and Products for Human Use. You can find the document under http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/latest_news/
gmp_annex2_03-2010.pdf

The revised draft of GMP Annex 2 contains additional guidance for the manufacture of biological medicinal products and specific guidance for certain types of products, e.g. ATMPs. This new draft reflects latest legislation and comments received from industry on the previous draft version.

HORN Pharmaceutical Consulting
CMC – GMP – Regulatory Affairs
Dr. Hiltrud Horn
Am Alten Schloß 1
D-76646 Bruchsal
Germany

Phone: +49 (0) 7251/305 527
Fax: +49 (0) 7251/305 528
Mobile: +49 (0) 160/5834 213
e-mail: info@horn-pharma.de
Internet: www.horn-pharma.de