EU GMP Annex 16: Certification by a Qualified Person and Batch Release

December 9, 2015

On October 12, 2015, EMA published GMP Annex 16, Certification by a Qualified Person and Batch Release.  Annex 16 provides guidance on the certification by a Qualified Person (QP) and on batch release within the EU of medicinal products for human or veterinary use holding a marketing authorization (MA) or made for export.  The principles of this guidance also apply to investigational medicinal products (IMP) for human use, subject to any difference in the legal provisions and more specific guidance published by the European Commission.

The Annex has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new quality control strategies. The revision has been carried out in the light of Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products.  This version also implements ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the manufacturing and importation authorisation (MIA) interpretation document, as applicable.  Also, some areas, where the interpretation by Member States has not been consistent, have been clarified.

Annex 16 goes into effect April 15, 2016.