A Heparin, Unfractionated CEP of the European Pharmacopoeia monograph is often referred to as a Heparin, Unfractionated Certificate of Suitability (COS). The purpose of a Heparin, Unfractionated CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Heparin, Unfractionated EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Heparin, Unfractionated to their clients by showing that a Heparin, Unfractionated CEP has been issued for it. The manufacturer submits a Heparin, Unfractionated CEP (COS) as part of the market authorization procedure, and it takes on the role of a Heparin, Unfractionated CEP holder for the record. Additionally, the data presented in the Heparin, Unfractionated CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Heparin, Unfractionated DMF.
A Heparin, Unfractionated CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Heparin, Unfractionated CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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