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 November 2024
19 November
NEW - 15-16 October CMDh minutes
11…
modified 19/11/2024
Meeting 12-14 November 2024: AgendaMeeting 15-16 October 2024: Agenda -…
modified 19/11/2024
Fluoroquinolones (for systemic and inhalation use)Date of publication:…
modified 04/11/2024
Template request for a recommendation on the classification of an unforeseen…
modified 04/11/2024
Template Letter of Intent for the submission of a type IA super-grouped…
modified 04/11/2024
Template Cover letter for the submission of variation applications in the MRP…
modified 04/11/2024
Guidance is available on the implementation of the amended Variations Regulation…
modified 31/10/2024
Variation Procedure
modified 31/10/2024
Added in October 2024
31 October
NEW - Amended Variation Regulation
25…
modified 31/10/2024
Q&A - List for the submission of variations for human medicinal products…
modified 31/10/2024