ASMF Holders who are supplying substances to more than one Centrally Authorised Product (CAP) should submit their ASMF to the Agency once and not for each application, as previously.
The mandatory format for ASMF submissions for human medicines is now eCTD or structured NeeS. The use of eCTD will become mandatory for all for centralised procedure human ASMF submissions from 1 July 2016. If an on-going application dossier started in eCTD format, all subsequent submissions should be in eCTD format in order to maintain the lifecycle (once eCTD it is not possible to revert to NeeS). The relevant guidance should be followed & the applicable technical validation criteria has to be passed (eCTD validation criteria and NeeS validation criteria).
For veterinary medicines the accepted electronic format is VNeeS and NeeS.
To ensure that the above is followed promptly, please refer to question 27 of EMA Presubmission guidance carefully and apply for an EMEA/ASMF/XXXXX number at your earliest convenience by submitting the EMEA/ASMF request form.
Please take a note of the EU ASMF Assessment worksharing pilot that started on 1st December 2013. A different EU/ASMF request form should be submitted when requesting participation in the EU worksharing procedure.
It is very important to note that the above two initiatives are different.
- The EMA eASMF submission rules are mandatory since 1st September 2013 and are applicable to all Centralised applications.
- The EU Assessment worksharing initiative is valid for Centralised and Decentralised procedures and is a voluntary pilot.
A valid ASMF should have either an EMEA/ASMF number or an EU/ASMF number, depending on the intended use of the ASMF by its holder. When applying for EMEA or EU ASMF numbers, or submitting any documentation quoting these, please note that they are not inter-changeable. Only one ASMF number should be quoted.
Updated draft version of the Practical Guidance on the use of the eCTD format for ASMFs for Active Substance Master File Holders and Marketing Authorisation Holders has been released for public consultation.. Please send your comments to EUM1Spec@ema.europa.eu by 29 July 2016.
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