Applications for Marketing Authorisations

General Information on Mutual Recognition and Decentralised Procedure relating to former Chapter 2 of the Notice to Applicants provided by the European Commission (Guidance according to Directive 2001/82/EC)

Information in this CMDv document is transferred from the Notice to Applicants Volume 6 A Chapter 2, which has been deleted from the European Commission Website. The information in this document has been updated to take into account current practices and presents the summary of general principles of mutual recognition and decentralised procedures. Details of the procedures can be found in the Best Practice Guides and Standard Operation Procedures provided below and under respective sections within the CMDv website.

 

Requests to act as RMS in DCP – Pre-submission instructions for applicants

 

Authorisation procedures

Advice on specific application types

Clock start dates

Please be also referred to the EMA-HMA Best Practice Guide Measures to Improve Predictability of Submissions