Submission of ASMF to SIDC

The information on active substance to support the application for registration of a medicinal product could be submitted  in one of the  following three ways:

  • Certificate of suitability to the Monograph of the European Pharmacopoeia (CEP)
  • Active substance Master File Procedure(ASMF)
  • Full details of manufacture- as  part 3 .2.S of Modul 3 submited with the MA application

Active substance Master File Procedure (ASMF)

  1. Last valid version of Applicant´s and Restricted part of ASMF is submitted with a Letter of Access, where the referred version is highlighted
  2. The ASMF should contain both parts (AP and RP) of the ASMF also in the case where Applicant´s part is submitted in Modul 3 of the documentation for registration of the medicinal product
  3. eCTD format is highly recommended
  4. The documentation could be submitted using electronic portal CESP. The submission should be accompanied by an e-mail notification to cesp.asmf@sukl.sk with following identification data:
    – CESP number
    – Active substance name
    – ASMF holder name
    – ASMF version number.
    The electronic version on CD/DVD or a hard copy are also acceptable with a contents in files containing appropriate data.

  5. The shipment should be addressed to Section of Scientific and Regulatory Affairs of Drugs Registration, OPKL, and designated as “ASMF”.

  6. Update of ASMF is submitted according to the EMA *  recommendation in Q& A as a type II variation:

 Question 3.4

  • How should a change to or update of an ASMF, which is part of Module 3 of a marketing authorisation, be submitted?
    An update or change of an ASMF as such is not foreseen in the Pharmaceutical Legislation and can only be addressed in connection with a marketing authorisation. The type of the variation is dependent on the type of the single changes introduced in the updated version. The update – including changes of the open as well as the restricted part - can be submitted as a grouped application according to the highest type of the single changes, if condition 5 of Annex III of the Variation Regulation applies.
    However, in case of substantial changes in the updated version of the ASMF it is recommended to submit a single variation of type II under category B.I.z.
  • In all cases, the changes must be submitted by the ASMF holder (open and closed part) and the marketing authorisation holder (open part).
  • Any variation concerning ASMF supporting a CEP, should be sent to EDQM for assessment. After the ASMF is assessed and a revised certificate is issued, NCA should be notified and a variation application should be submitted.


*EMA  European Medicines Agency

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