For veterinary medicines the accepted electronic format is VNeeS and NeeS.
To ensure that the above is followed promptly, please refer to question 24 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.
Related Documents and Templates
• EMA Presubmission guidance
• EMEA/ASMF number request template request form
• EU/ASMF number request template request form
• Letter of Access Template (Previously Annex 2), Template Administrative Information – (Previously Annex 3), Template Withdrawal of Access Letter –Should be filled in in accordance of the ASMF type (EU/ASMF/XXXXX or EMEA/ASMF/XXXXX)
• EU ASMF Assessment Worksharing
• Active Substance Master File Procedure Guidance
References:
EMA,
