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
European Medicines Regulatory Network COVID-19 Business Continuity Plan
added 28/05/2020
RMS Validation Checklist for human medicinal products in DCP (April 2020)
added 11/05/2020
Palexia, Yantil, Tapentadol Grünenthal (tapentadol (as hydrochloride) ...
added 11/05/2020
Data requested for Variations and/or Renewal Applications in the MRP/DCP
added 11/05/2020
Additional Data requested for New Applications in the Mutual Recognition and...
added 11/05/2020
CMDh Best Practice Guide on the use of eCTD in the MRP/DCP
added 11/05/2020
Q&As on the implementation of the outcome of the Art. 31 referral on...
added 11/05/2020
Practical guidance for procedures related to Brexit for medicinal products for...
added 11/05/2020
List of safety concerns per approved Risk Management Plan (RMP) of active...
added 08/05/2020
Meeting 26-27 May 2020: Agenda Meeting 28-29 April 2020: Agenda - Minutes ...
added 04/05/2020