Annex 16 application to IMPs
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Does section 1.1 Annexe 16 apply to IMPs prepared in Europe for export to the USA i.e. do they need to be QP certified, or just QA released?
GMP Committee response
The straightforward answer to this question is yes. The basis for this answer can be found in the first paragraph of the scope of Annex 16: “This Annex provides guidance on the certification by a Qualified Person (QP) and on batch release within the European Union (EU) of medicinal products for human or veterinary use holding a marketing authorisation (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”