Annex 1 Consultation Document: Where Are We Heading?

Time: 3:45 pm - 4:15 pm

Date: 13 March


The current (2008) version of Annex 1 of the EU GMPs consists of 127 paragraphs spread over 16 pages. The draft of the new Annex 1 has been published by the European Commission and it is open to consultation up to 30 March 2018. With exactly 50 pages the new document has more than doubled. In this presentation I will give an overview of additional requirements, as well as changes to existing requirements.


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