FAQ n.19007

Can manufacturers of raw materials obtain a Production Organisation Approval (POA) under Part 21 Subpart G? (19/11/2004)


The Agency has concluded after a thorough review that the current Basic Regulation and Part 21 do not provide for the approval of manufacturers of raw materials. Only organisations responsible for the manufacturing and subsequent release of a 'product' and 'parts and appliances' as defined in the Basic Regulation Article 3 (c) and (d) are required to hold a POA and are therefore eligible to apply for such an approval. ED Decision 2007/012/R introduced an amendment to AMC/GM to Part-21 bringing all AMC and GM to Part 21 back into line with the EC Regulations regarding this issue and thus removing any ambiguity.

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