Submission of confidential file for the active substance (or the
"European Active Substance Master File (ASMF)") to ANSM
Under the terms of the decree of 23 April 2004 ("standards and protocols"), applicants for
marketing authorization, when compiling their dossier, should take into consideration the
guidelines published by the European Commission and by the European Medicines
Agency (EMA).
Accordingly, in conformity with:
 The European note for guidance ‘GUIDELINE ON ACTIVE SUBSTANCE MASTER FILE
PROCEDURE’ CHMP/QWP/227/02 Rev 3/ Corr. – adopted on 21 June 2012
(http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline
/2012/07/WC500129994.pdf )
 Additional guidance on documents relating to an active substance master file
http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-2/b/ctd-qaupdatev3_2008-02_en.pdf)
 EU CTD Q&A #14 and #16
http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-2/b/ctd-qaupdatev3_2008-02_en.pdf)
 The European Medicine Agency’s Human Medicines - Pre-Submission Procedural
Advice - Questions & Answers - #19
(http://www.ema.europa.eu/htms/human/presub/q19.htm)
it is recommended that any confidential file for the active substance (or the "European
Active Substance Master File (ASMF)") submitted to ANSM obeys the format of the
relevant parts
 Module1 including
o Part 1.0: Submission Letter and Administrative Details, Letter(s) of Access ,
List of changes ( between 2 versions of ASMF, if relevant),
o Part 1.2: ASMF Application Forms
o Part 1.4 Information concerning the experts containing a summary of the
curriculum vitae, dated and signed by the expert who drafted module 2 of the
CTD,
 Module 2- part 2.3.S – Active substance Quality Overall Summary,
 Module 3 –part 3.2.S - Active substance Documentation
of the Common Technical Document (or CTD) (see EU CTD :
http://ec.europa.eu/health/files/eudralex/vol-2/b/update_200805/ctd_052008_en.pdf)
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I – Which type of documents should be submitted?
Module 1
Submission
Letter includ.
Initial
submission
of ASMF
Update or
Variation of
ASMF
+
+
+
+
Response
to
questions
+
Administrative
change (Change of
ASMF
HolderChange of Name
and/or Address of
ASMF
Holder/
Active Substance
Manufacturer)
Withdrawal
of ASMF
+
Administrative
(1)
Details
Letter(s) of
Access(2)
Module 2(6)
Module 3(7)
List
of
changes(1)
Copy
of
Deficiency
Letter
Copy
of
certificate
of
Suitability
ASMF
Application
Form(4)
Information
concerning
the
expert(s)(5)
Applicants
Part
Restricted
Part
Applicants
Part
Restricted
Part
+
Withdrawal
Access
Letter(3)
+
+
+ (if
relevant)
+
+
+
+
+
(if updated)
+
(if updated)
+
(if updated)
+
(if updated)
+
(if relevant)
+
(if relevant)
+
+
+
+
+
(1)
= the template of Cover Letter is in the Annex 3 of ‘GUIDELINE ON ACTIVE SUBSTANCE MASTER FILE PROCEDURE’
CHMP/QWP/227/02 Rev 3/ Corr’
(2)
the template of Letter of Access is in the Annex 2 of ‘GUIDELINE ON ACTIVE SUBSTANCE MASTER FILE PROCEDURE’
CHMP/QWP/227/02 Rev 3/ Corr’
(3)
the template of Withdrawal of Access Letter is in the Annex 4 of ‘GUIDELINE ON ACTIVE SUBSTANCE MASTER FILE
PROCEDURE’ CHMP/QWP/227/02 Rev 3/ Corr’
(4)
= a tabular comparison between the old and the new contents of the "ASMF",
(5)
one copy of the application form of the "ASMF" file including the relevant annexes should be provided; this form is available
for downloading at the following link:
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http://www.ansm.sante.fr/Activites/Autorisations-de-mise-sur-le-marche/Substances-actives-a-usage-pharmaceutique-ActiveSubstance-Master-File
(3)
= a copy of part 1.4 of CTD module 1 containing a summary of the curriculum vitae, dated and signed by the expert who
drafted module 2 of the CTD.
(6)
= one copy of part 2.3.S of CTD module 2 (or the Quality Overall Summary) distinguishing between the open part (Applicants
Part) and the closed part (Restricted Part) in two separate documents.
(7)
= one copy of part 3.2.S of CTD module 3 distinguishing between the open part (Applicants Part) and the closed part
(Restricted Part) in two separate documents.
II- Which format of documents should be submitted?
Three optional types of format can be used.
II-1 eCTD
The implementation of eCTD to ASMF follows the European note for guidance ‘PRACTICAL
GUIDELINES ON THE USE OF THE eCTD FORMAT FOR ASMFs FOR ACTIVE
SUBSTANCE MASTER FILE HOLDERS AND MARKETING AUTHORISATION HOLDERS’
EMA/43526/2010 v 1.0 ( http://esubmission.emea.europa.eu/doc/index.html )
The electronic copy should content the entire file including administrative data along with
Ansm’s Application Form (PDFtext or WORD format) (Module 1) and scientific data
(Module 2 and Module 3).
Only one copy of the media units (PDF 1.4 format) should be submitted as follows:
DCI / INN
Nom de la substance/ Active substance name Code
producteur de la substance/ASM’s internal API code
ASMF No. (if available)
eCTD
Nom détenteur d’ASMF /
ASMF holder’s name
Séquence / sequence - - - Date de soumission
(JJ/MM/AAAA)/
Submission
date(DDMM/YYYY)
Type de soumission /Submission Type
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II-2 Non-eCTD electronic Submission (NeeS)
The implementation of eCTD to ASMF follows the European guideline ‘Guidance for Industry
on Providing Regulatory -Information in Electronic Format:Non-eCTD electronic Submissions
(NeeS)for human medicinal products’ (http://esubmission.emea.europa.eu/doc/NeeS
eGuidance Document version 2.0.pdf)
The file naming should follow the naming conventions used for ectd format : see ICH, eCTD
specification v3.1, "naming conventions" http://estri.ich.org/eCTD/index.htm
The electronic copy should content the entire file including administrative data along with
Ansm’s Application Form (PDFtext or WORD format) (Module 1) and scientific data
(Module 2 and Module 3).
Only one copy of the media units should be submitted as follows:
DCI / INN
Nom de la substance/ Active substance name
Code producteur de la substance/ASM’s
i t
l API d
ASMF No. (if available)
EU-NeeS
Nom détenteur d’ASMF /
ASMF holder’s name
Date de soumission
(JJ/MM/AAAA)/
Submission
date(DDMM/YYYY)
Type de soumission /Submission Type
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II-3 Electronic and paper copies
Only electronic copy of the file (PDFtext or WORD format) should be submitted. This copy
should content the entire file including administrative data along with Ansm’s Application
Form (PDFtext or WORD format) (Module 1) and scientific data (Module 2 and Module 3).
The copy of the media units should be submitted as follows:
DCI / INN
Nom de la substance/ Active substance name Code
producteur de la substance/ASM’s internal API code
ASMF No. (if available)
CD+Paper
Nom détenteur d’ASMF /
ASMF holder’s name
Date de soumission
(JJ/MM/AAAA)/
Submission
date(DDMM/YYYY)
Type de soumission /Submission Type
Only one paper copy of the entire file should be submitted with a signed declaration from
the ASMF applicant stating that the electronic and paper versions are identical.
The documents supplied must be bound (e.g. adhesive binding, spiral binding) (with the
exception of the letter(s) of access and the three copies of the application form). Binders are
not accepted.
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The cover page of each volume should be submitted as follows:
ASMF No.
Active Substance Name
ASM’s Internal API Code
ASMF Holder’s Name
Submission Type
Module x + Date and/or Version No.
(/For initial submission and update)
Date of Deficiency letter
(For response to questions)
Submission Date (DDMM/YYYY)
(i.e. Date of Cover Letter)
Volume X of Y
III-When and where should the documents be submitted?
All documents relative to an ASMF to be sent at least one month before the submission of
Marketing Authorization Application or Marketing Authorization Variation to:
Madame Béatrice BLAISOT
ANSM
DQFR – PGF – 530
143-147 Bd Anatole France
F-93285 Saint-Denis cedex.
IV- How to obtain additional information?
Any request should be sent to the following Internet address: DMF-ASMF@ansm.sante.fr
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