Annex 16: Pharma Supply Chain Regulation in the European Union

INSIGHTS
annex-16

Online via GoToWebinar

 

A free collaborative webinar was hosted by Enterey and BSMA (Bio Supply Management Alliance) discussing the implications of Annex 16 on biotech and pharmaceutical supply chains.

 

In April 2016, the European Commission's Annex 16 "Certification by a Qualified Person and Batch Release" came into effect. This revision increased the requirements for both medicinal products for human use with a marketing authorization (MA) and Investigational Medical Products (IMPs) imported into the EU/EEA. A new requirement - section 1.7.2 - calls for end-to-end visibility of the supply chain in the form of a Supply Chain Diagram.

 

Join the webinar to learn more about the scope of the Supply Chain Diagram and how to adapt your processes in order to provide this information to a Qualified/Responsible Person.

 

Access the webinar recording here.

Annex 16: Pharma Supply Chain Regulation in the European Union