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) - will be further developed taking into account the new legislation
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.
Advice on specific application types
Please be also referred to the EMA-HMA Best Practice Guide Measures to Improve Predictability of Submissions