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.


Back

HOTLINE

Phone +49 (0) 7251/305 529
Fax +49 (0) 7251/305 528
Mail

Events

  • 18.-19.06.2024
    Online Seminar: Der Regulatory Affairs Manager
    More
Get all events



News

  • 19.12.2022
    EU Update regarding Deadlines of Nitrosamine Impurities
    More
  • 01.09.2022
    EU-GMP Annex 1 finally published
    More
  • 26.08.2022
    New Deadlines and Chances for Nitrosamines
    More
Get all news