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Eudralex Volume 3 Guideline on the Chemistry of Active Substances (3AQ5A)
EMA
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Document Type:
Guideline
Content:
This guideline describes the type of information required for new active substances used for the first time in a medicinal product, which are not described in the European Pharmacopoeia or a pharmacopoeia of a Member State.