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All you ever wanted to know about Ph. Eur. procedure 4 but never dared to ask!

European Pharmacopoeia
20 January 2022
Strasbourg, France

This document is intended to help stakeholders understand the advantages of applying for a monograph elaboration via European Pharmacopoeia (Ph. Eur.) procedure 4. It describes how Group P4 has elaborated P4 monographs over the last 10 years. It also applies to monographs on biotherapeutics as elaborated by the P4bio Working Party.

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