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.
Biologicals (October 2012)
CMDh meeting with Interested Parties - 24 May 2016
PresentationsCMDh strategy t...
CMDh SOP on the processing of PSUR single assessment for nationally authorised p...
Requirements on submissions (number and format) for Variations and Renewals with...