Based on practical experiences a revision of the Annex 13 (Investigational Medicinal Products) was deemed necessary to clarify certain points related to reference and retention samples, the two-step release procedure for investigational medicinal products and to the principle of independence between production and quality control functions.

Comments should be sent to entr-gmp@ec.europa.eu and GMP@emea.europa.eu by 31 October 2008.

The following changes are proposed for Annex 13:

• A minor change has been made to section 3 in order to reinforce the principle of independence between production and quality control functions in cases where the number of personnel involved is small.
• Changes are proposed to sections 36 and 37 to supplement, for investigational medicinal products, the guidance for reference and retention samples given in Annex 19.
• Section 44 has been reworded to enhance understanding of the two-step release procedure that applies to investigational medicinal products.

You can find the document here: http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/2008_04/
gmp_annex_consult13_200804.pdf

Compiled by:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)