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)
- Last valid version of Applicant´s and Restricted part of ASMF is submitted with a Letter of Access, where the referred version is highlighted
- 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
- eCTD format is highly recommended
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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.
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The shipment should be addressed to Section of Scientific and Regulatory Affairs of Drugs Registration, OPKL, and designated as “ASMF”.
- 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?
Answer:
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
