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Draft toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications (PDF/912.2 KB)

Draft: consultation open
First published: 02/02/2021
Consultations dates: from 02/02/2021 to 31/07/2021
EMA/CHMP/BWP/QWP/IWG/694114/2019
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Second draft European Union herbal monograph on Hypericum perforatum L., herba (traditional use) - Revision 1 (PDF/220.26 KB) (new)

Draft: consultation open
First published: 16/04/2021
Consultations dates: from 15/04/2021 to 15/07/2021
EMA/HMPC/7695/2021