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Guideline on the chemistry of active substances

Guideline concerning the application of Directive 2001/83/EC with a view to the granting of a marketing authorisation for a medicinal product. This guideline replaces the ‘Note for guidance on chemistry of new active substances’ (CPMP/QWP/130/96, Rev 1) and ‘Chemistry of active substances’ (3AQ5a). It has been revised to cover new and existing active substances in one guideline.



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