Simplified renewal application for marketing authorisations
The regulatory procedures for renewal applications for Mutual Recognition Procedures (MRP) and Decentralised Procedures (DCP) have been simplified with the publication of the CMDh update of the Best Practice Guide for renewals in February 2023.
The standard renewal procedure for all marketing authorisations, regardless of legal basis, is now limited to the submission of a cover letter and application form without attachments and a shorter timetable (30 days).
An extended procedure with an extended timetable (90 days) and full documentation will only be required in exceptional cases.
For more information please see the CMDh Best Practice Guide (pdf).
CMDh: Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human.