Response to deficiency letter regarding an European ANSM

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					                               Response to a Deficiency Letter
                               regarding an European Active
                                Substance Master File (ASMF)


                                          - Instructions -

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 (EMEA).
Accordingly, any request related to additional information concerning a confidential file for an active
substance (or "European Active Substance Master File (ASMF)"), or a change of "ASMF" holder (name
and/or address) or the closing of an "ASMF" file must be submitted to Ansm, accompanied by:


        Three copies (paper format) of the form corresponding to the request; the forms are to be
         downloaded from http://ansm.sante.fr
        An electronic copy of the file (PDFtext or WORD format) with a signed declaration from the ASMF
         applicant starting that the electronic and paper versions are identical.



The various documents supplied must be bound, preferably by hot binding (with the exception of the three
copies of the application form).


The correspondence should be sent to:


Agence nationale de sécurité du médicament et des produits de santé
Madame Béatrice BLAISOT - DEMEB/DEQPh/Cellule matières premières (DMF)
143-147 boulevard Anatole France - F-93285 SAINT-DENIS CEDEX


Requests for additional information should be sent to the following Internet address: dmf@ansm.sante.fr.




Formulaire ANSM / Mai 2012                  www.ansm.sante.fr                                    Page 1 sur 2
                                            APPLICATION FORM: ADMINISTRATIVE DATA
                                   ASMF No. assignated by Ansm
                                      Response to a Deficiency Letter regarding an European
                                                                   Number of (ASMF)
                                                Active Substance Master File volumes
                                   Date of submission



     Active Substance: Name &
                   Internal code


     ASMF Holder: Name
                  Contact person at following address
                  Address
                  Country




                      Telephone
                      Telefax
                      E-mail


     Date of Deficiency Letter from Ansm

         Attach a copy of Afssaps Deficiency Letter (Annex 1)


To be filled in by Ansm

   Submission acceptable for assessment          Date:                    Signature:

   Submission acceptable for assessment
  (see reasons in annex A)




     Formulaire ANSM / Mai 2012               www.ansm.sante.fr                        Page 2 sur 2

				
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