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
Requirements on submissions (number and format) for New Applications within MRP,...
added 10/07/2020
Notification Form (June 2020) [PDF]
added 10/07/2020
Cover letter for Variation Applications in the Mutual Recognition Procedure
added 10/07/2020
Template: Cover letter for new applications submitted through MRP/DCP
added 10/07/2020
Flow chart of the Decentralised Procedure (March 2013) [Track version]
added 08/07/2020
CMDh Best Practice Guide on Multilingual Packaging (June 2020) [Tracked...
added 08/07/2020
Procedural guidance during COVID-19 pandemic
added 08/07/2020
CMDh Best Practice Guide on the processing of renewals in the MRP/DCP (April...
added 08/07/2020
Silkis ointment (calcitriol) End of procedure: 13/05/2020 Date of...
added 08/07/2020
Added in July 2020
10 July 2020
Cover letter for Variation Applications in...
added 07/07/2020