ASMF
1. How do I submit ASMFs?
For information on the submission of documents, please refer to:Electronic Submission Regulation EEVO (L_Z45). Note that ASMFs for all types of applications must be submitted in eCTD format (only exception: exclusively for veterinary applications).
For further information, please refer to the following links:
2 What is an ASMF worksharing?
ASMF holders often make their ASMF available to several finished product manufacturers, which is why it is possible for several authorisation holders to reference the same ASMF. This can lead to redundant, multiple assessments of an ASMF by different authorities. ASMF worksharing was therefore introduced at European level to ensure efficient and high-quality assessment. A separate ASMF numbering system was developed for this purpose, which enables standardised identification and allocation of ASMFs. Worksharing ASMFs can be identified by the assigned "EU/ASMF" number. For further information, please refer to the CMDh website: Heads of Medicines Agencies: Working Group on Active Substance Master File Procedures
3. What requirements must an Active Substance Master File (ASMF) fulfill, that is attached to an application for authorisation, variation or renewal?
If an ASMF is attached to a submission, the latest version of the ASMF must be submitted. This must correspond to the current state of knowledge - in accordance with the current European requirements.
4. How should an ASMF for more than one authorisation application be submitted by the ASMF holder?
The ASMF holder should submit the ASMF in its latest version only once. For the correct technical handling and maintenance of an eCTD life cycle of this stand-alone active substance documentation, the ASMF does not have to be submitted repeatedly for each individual authorisation or variation application. Both changes to the ASMF and additional "letters of access" for further authorisation applications are submitted with an updated eCTD sequence.
For example: An ASMF is submitted with the eCTD sequence 0000 for the medicinal product speciality A. For a further authorisation application for medicinal product B, the ASMF holder should submit the new "Letter of Access" in a subsequent eCTD sequence (e.g. eCTD sequence 0001, 0002, ...).
