EMA Guideline on the Chemistry of Active Substances

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Active Substance

Are you preparing submissions to the EMA for marketing authorization this year?  This guideline goes into effect in July 2017 and describes the type of information required for the manufacture and control of active substances used in medicinal products for EMA marketing authorization. It replaces the “Note for guidance on chemistry of new active” (CPMP/QWP/130/96, Rev 1) and “Chemistry of active substances” (3AQ5a) and covers new and existing active substances in one guideline. 

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