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

Contact Points
modified 02/07/2025

Added in July 2025 01 July UPDATE - SOP on the processing of PSUR single…
modified 01/07/2025

CMDh SOP on the processing of PSUR single assessment for nationally authorised…
modified 01/07/2025

Data requested for Variations and/or Renewal Applications in the MRP/DCP
modified 01/07/2025

Additional Data requested for New Applications in the Mutual Recognition and…
modified 01/07/2025

Requirements on submissions for Variations and Renewals within MRP and National…
modified 01/07/2025

Requirements on Submissions for New Marketing Authorisation Applications within…
modified 01/07/2025

Meeting with Interested Parties - 19 June 2025 AgendaPresentationsCMDh -…
modified 01/07/2025

Member: Ana López de la Rica ManjavacasAlternate: María Teresa Sanz…
modified 01/07/2025

Variation Procedure
modified 30/06/2025