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:
- Post-Authorisation Efficacy Studies (PAES) in MRP/DCP(November 2015)
- Product Information/Information on Medicinal Products [Track version] (October 2017)