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
Overview of timetables
modified 13/01/2026
Member: María Teresa Sanz PortilloAlternate: Elisa SulleiroAgencia Española del…
modified 13/01/2026
IMPLEMENTATION OF THE VARIATIONS FRAMEWORK
Marketing authorisation holders…
modified 12/01/2026
Added in January 2026
08 January
CORRECTION - CMDh Recommendation for…
modified 08/01/2026
CMDh Recommendation for classification of unforeseen variations according to…
modified 08/01/2026
Mock-ups, Specimens and Samples for new applications
modified 07/01/2026
Guidance on the work sharing procedure for the assessment of Active Substance…
modified 07/01/2026
Member: vacant Alternate: Rui Pedro da Costa Vilar
INFARMEDParque de Saúde de…
modified 19/12/2025
Marta Marcelino
INFARMEDParque de Saúde de LisboaAvenida do Brasil, n°…
modified 19/12/2025
List of active substances for which data has been submitted in accordance with…
modified 18/12/2025