GMP: New Q&A Document of the CMDh gives Answers to Essential Questions on the ASMF Procedure

The Co-ordination Group of Mutual Recognition and Decentralised Procedures (CMDh) has published a Questions & Answers document regarding the Active Substance Master File (ASMF) procedure. In this document, the CMDh has clariified some issues which were still open and essential for the ASMF holder and the applicant in connection with the ASMF procedure and the submission of changes in the context of a marketing authorisation procedure.