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
Added In December 2024
19 December
NEW - Report from the meeting held on…
modified 01/07/2025
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
Contact Points
modified 01/07/2025