Basic Requirements for Active Substances used as Starting Materials
Basic Requirements for Active Substances used as Starting Materials
EU GMP Guide Part II Basic Requirements for Active Substances used as Starting Materials - GMP compliance for Active Substances
4. Question (H+V July 2006):
How do the new requirements affect importers of medicinal products?
Answer:
Importers are manufacturing authorisation holders and so the obligations under Art. 46f/50f of
Directive 2001/83(2) apply to them. For importers the possibility of a "second party" audit
performed by the third country manufacturer that uses the active substance as a starting material
may be a further option. Importers are already obliged to ensure the third country manufacturer
complies with standards of GMP equivalent to those of the European Community and should have
established arrangements in line with Chapter 7 of the Guide. They should therefore be fully
satisfied that the third country manufacturer has adequately demonstrated that the active
substances it uses for products destined for the European Community have been manufactured in
accordance with GMP. Importers may of course choose to verify the standards of GMP at the
active substance suppliers themselves or through a third party. Whichever option is chosen
the questions and answers given above are also relevant.