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FAQ n.19007

Can manufacturers of raw materials obtain a Production Organisation Approval (POA) under Part 21 Subpart G?

Answer

Manufacturers of raw materials are not required to hold and cannot obtain a production approval. Only organisations responsible for the manufacturing and subsequent release of a 'product', 'parts’ and ‘non-installed equipment’ as defined in the Basic Regulation Article 3 (3), (4), and (29) are required to hold a POA, if and as specified by Regulation (EU) No 748/2012, and are therefore eligible to apply for such an approval. 

Last updated
18/07/2019

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