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
List of documents published on CMDh website (October 2026)(to be used to locate…
modified 27/10/2026
Added in October 2026
27 October
UPDATE - 'Blue-box' requirements
23…
modified 27/10/2026
'Blue-box' requirements
modified 27/10/2026
Decisions on additional year of market protection/data exclusivity for new…
modified 23/10/2026
Additional Data requested for New Applications in the Mutual Recognition and…
modified 22/10/2026
MRP / RUP
modified 22/10/2026
List of active substances for which data has been submitted in accordance with…
modified 22/10/2026
Request for RMS in a Decentralised Procedure, medicinal products for human use
modified 22/10/2026
Data requested for Variations and/or Renewal Applications in the MRP/DCP
modified 22/10/2026
Procedural advice: Validation of MR/Repeat-use/DC Procedures
modified 22/10/2026