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According to Resolution AP-CSP (07)1, the procedure for ‘Certification of Suitability to the Monographs of the European Pharmacopoeia’ (CEPs) is intended for substances for which a monograph, either general or specific, has been adopted by the European Pharmacopoeia Commission. The procedure does not apply for direct gene products (i.e. proteins), products obtained from human tissues, vaccines and blood products and preparations.

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