Active Substance Master File (ASMF)/CEP

Active Substance Master File (ASMF) allow valuable confidential intellectual property or ‘knowhow’ of the manufacturer of the active substance to be protected, while at the same time allowing the Applicant or Marketing Authorization (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance.

The mandatory format for ASMF submissions for human medicines is now eCTD or structured NeeS. The use of eCTD will become mandatory for all for centralized procedure human ASMF submissions from 1 July 2016. If an on-going application dossier started in eCTD format, all subsequent submissions should be in eCTD format in order to maintain the lifecycle (once eCTD it is not possible to revert to NeeS).

Sarjen with its off-the-shelf software, KnowledgeNET, and effective strategic consultancy, simplifies the complexity of the XML backbone structure.

ASMF publishing software – features

    • Module 1 document mapping and granularity management
    • ASMF submissions for human medicines in eCTD or structured NeeS format
    • ASMF life cycle management
    • EMA specific Document formatting and publishing
    • Navigation Aid Management including the table of contents and hyperlinks
    • For small sized API companies, we provide Pay per Dossier conversion to create eCTD based ASMF submissions

Other dossier submission key features click here

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