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.
The use of eCTD is mandatory for all for centralised procedure human ASMF submissions since 1 July 2016. The use of eCTD is mandatory for ASMFs used for DCP/MRP human procedures from 1 January 2018. Use of eCTD is mandatory for new national MAAs since 1 July 2018 and from 1 January 2019 for all other submission types. The relevant guidance should be followed and the technical eCTD validation criteria must be passed.
To ensure that the above is followed promptly, please refer to the human EMA Pre-authorisation guidance carefully and apply for an EMEA/ASMF/XXXXX number at your earliest convenience by submitting the EMEA/ASMF request form.
For veterinary medicines the accepted electronic format is VNeeS and NeeS and for ASMFs also exceptionally eCTD is allowed. More information can be found from the Veterinary Pre-submission guidance.
Please take a note of the voluntary EU ASMF Assessment worksharing. 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.
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.
It is mandatory to use XML delivery files for ASMF submissions using the eSubmission Gateway and the Web Client.
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.