ANSM - Agence nationale de sécurité du médicament et des produits de santé Formulaire – MED590
Contact ANSM
DMFR – MPF – 530
143-147, bd Anatole France F-93285 SAINT-DENIS CEDEX
ASMF SUBMISSION FORM: ADMINISTRATIVE DATA regarding an European Active Substance Master File (ASMF)
ASMF Number as allocated by ANSM (if available):
Date of Submission Letter:
Active Substance : Name: Manufacturer Internal Code:
ASMF Holder :
NameContact person at following address
Address Country
Type of submission :
New submission
Update to ASMF
Total (submission of a complete file superseding the previous version) Partial (submission of a complementary file modifying the previous version)
Compilation (submission of a compilation of the previous version including responses to different deficiency letters)
Response to Deficiency Letter along with the copy of the Deficiency Letter
Administrative change
Change of ASMF Holder Change of Name/Address of ASMF Holder
Change of Name/Address of Active Substance Manufacturer
Request for closing of ASMF along with Withdrawal of Access Letter(s)
Replacement by a Certificate of Suitability (CEP) : CEP Number : Module 3- Applicants Part: version number
(Name ASMF Holder/Name Active Substance/AP/version number/date in yyyy-mm-dd)
Module 3- Restricted Part: version number
(Name ASMF Holder/Name Active Substance/RP/version number/date in yyyy-mm-dd)
Module 1- Information about the Expert : Name of the Expert’s:
Enclose a copy of the Submission Letter and Administrative Details for documents relating to an Active Substance Master File (ASMF) (Annex 3 of the European Guideline on Active Substance Master File Procedure
CHMP/QWP/227/02 Rev 3 – adopted on 21 June 2012) including:
Table of changes (for Update of ASMF)
Copy of Deficiency Letter (for Response to Deficiency Letter)
Enclose letter(s) of withdrawal of Access Letter (for Request for Closing of ASMF)
To be filled in by Ansm Date : Signature :
Complete Submission for assessment
Submission to be completed for assessment (see reasons in annex A)
ANSM Version 1 – (Février / 2014) www.ansm.sante.fr 1 / 1
