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 May 2025
28 May
UPDATE - National information on MAH transfersUPDATE…
modified 28/05/2025
Questions and answers
A question-and-answer document is available for marketing…
modified 28/05/2025
Information on nitrosamines for marketing authorisation holders
modified 28/05/2025
European Medicines Regulatory Network approach for the implementation of…
added 28/05/2025
For additional specific information related to nationally authorised products…
added 28/05/2025
Questions and answers
A question-and-answer document is available for marketing…
added 28/05/2025
Information on nitrosamines for marketing authorisation holders
added 28/05/2025
National information on MAH transfers (May 2025)
modified 28/05/2025
Bilaxten and associated names (bilastine)End of procedure: 03/02/2025Date of…
modified 28/05/2025
Practical guidance on the implementation of the Protocol on Ireland/Northern…
modified 28/05/2025