Questions & Answers
This Question and answers section gives advice on regulatory issues in connection with the Mutual Recognition and Decentralised Procedures. Reference is made, where additional information is available from CMDh guidance documents.
For general regulatory guidance on the interpretation and implementation of the new pharmaceutical legislation, please refer to the Notice to Applicants, where updated guidance will be published by the European Commission.
Index Questions & Answers:
- Biologicals (October 2012)
- Homeopathics (October 2012)
- Post-Authorisation Efficacy Studies (PAES) in MRP/DCP (November 2015)
- Post referral phase (November 2012)
- Product Information/Information on Medicinal Products (October 2012)
- Renewals (November 2012)
- Usage Patents (October 2012)