EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
31.01.2013
- Deadline for coming into operation: Jan. 31, 2013 -
On Sept. 9, 2012 the European Commission published the revised GMP Annex 2: Manufacture of Biological Medicinal Substances and Products for Human Use. You can find the document under
http://ec.europa.eu/health/files/eudralex/vol-4/vol4-an2__2012-06_en.pdf
The revised 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 document reflects latest legislation and comments received from industry on the previous draft version.
