To the attention of the ASMF holders / Applicants who use the ASMF procedure
We inform you that, starting with 26.05.2014, submission of the Active Substance Master File (ASMF) will be accepted only if it is done according to the “Guideline on Active Substance Master File Procedures”
ASMF can only be submitted in support of an Marketing Authorisation Application (MAA) or Marketing Authorisation Variation (MAV) and must be synchronised to arrive at approximately the same time as the MAA or the MAV i.e. not more than one month before and not after the intended MAA/MAV submission date. Requirement applies to all types of application or variation, either a national or decentralised or mutual recognition procedures.
Any ASMF must be accompanied by a Submission Letter and Administrative Details, see Annex 3 to the guide.
Any update to the ASMF must be accompanied by a Submission Letter and Administrative Details along with the Table of Changes, see Annex 3 to the guide.
Any responses to deficiency letter from a competent authorities concerning the ASMF must be accompanied by a Submission Letter and Administrative Details, see Annex 3 to the guide.
The ASMF holder has to issue the Letter of access containing the acceptance that the EEA National Competent Authorities, the EMA including all CHMP and CVMP Members and their experts, and the Certification of Substances Division of the European Directorate for the Quality of Medicines & Healthcare may share the assessment reports of the above mentioned Active Substance Master File amongst themselves, see Annex 2 to the guide.
Withdrawal of access to the ASMF has to be announced by means of a Letter of Withdrawal submitted for different procedures, see Annex 4 to the guide.