Human Medicines
This area of the website provides information relating to the regulation of human medicines, including access to product information, pharmacovigilance and the directory of relevant agencies.
HUMAN MEDICINES | RECENTLY PUBLISHED
Member: Heili TikkAlternate: Annela Raidma
State Agency of Medicines1 Nooruse…
modified 15/09/2025
Summary PAR - Generics (July 2014)
modified 15/09/2025
PAR for refused marketing authorisation applications (January 2017)
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Summary PAR for non-generics (June 2014)
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PAR update (December 2009)
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PAR Scientific discussion (February 2014)
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Added in September 2025
15 September
NEW - 16-18 September CMDh agenda
09…
modified 15/09/2025
Meeting 16-18 September 2025: AgendaMeeting 22-23 July 2025: AgendaMeeting 17-19…
modified 15/09/2025
The marketing authorisation holder (MAH) is responsible to keep its product…
modified 15/09/2025
CMDh QRD annotated template for MRP/DCP
modified 09/09/2025