ASMF definition

ASMF has the meaning set forth in Section 5.3 (Correspondences with Regulatory Authorities).
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ASMF or "DMF" shall mean the "Active Substance Master File" or the "Drug Master File" written by Biofrontera with support byHapila.
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ASMF means the drug master file formerly known as European Drug Master File (EDMF) as specified in the European Medicines Agency's Guideline on Active Substance Master File Procedure, and in Annex I to Directive 2001/83/EC as amended Part I, 3.2 Basic principles and requirements, (8) Active Substance Master File (for Human medicinal products).
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Examples of ASMF in a sentence

  • Hapila shall be entitled to have the API manufactured by Hapila with the involvement of Third Parties provided that such Third Parties are registered as manufacturers or contract testing laboratories in the ASMF for the API and the marketing authorizations for Ameluz.

  • The prices are to be understood CPT Switzerland or Germany (INCOTERMS 2010), excluding any fees charged by authorities for or related to the PRODUCT, the API, the ASMF, the DMF and the MANUFACTURER.

  • Promptly following the Effective Date, Licensor will deliver to Licensee (i) the Transferred Materials and (ii) all pre-clinical and clinical data and information and other tangible Licensed Technology, including all data in the Drug Master File (DMF) and Active Substance Master File (ASMF) for the API.

  • After termination of this contract, MIDAS shall maintain the ASMF and DMF active as long as BIOFRONTERA has PRODUCT manufactured with MIDAS API on the market and the associated change/variation is approved.

  • Therefore the delimitation between an open part and a closed part of the Drug Master File, - hereinafter referred to as DMF, and of the Active Substance Master Files, - hereinafter referred to as ASMF - does not apply any longer in the European Community (EC) and both the DMF and the ASMF have to be revealed to Licensee.


More Definitions of ASMF

ASMF means the Drug Master File filed with the FDA or the Active Substance Master File filed with the EMA for the BULK DRUG SUBSTANCE manufactured at Onoda Factory by Mitsubishi Tanabe Pharma Factory Ltd. The exact timing and form of the foregoing transfers shall be determined by VIVUS at its sole and reasonable discretion based on guidance from regulatory consultants and/or the responsible regulatory authorities. Such transfer of title to the DMF and ASMF shall occur automatically at the time determined by VIVUS, and MTPC agrees to take all reasonable actions necessary to effectuate or record such transfer, consistent with the form of transfer determined by VIVUS. Following such transfer, VIVUS shall be the sole holder of the DMF and ASMF. However, VIVUS acknowledges that all data and information included in the DMF and ASMF (collectively, “REGULATORY FILE INFORMATION”) shall be and remain the exclusive property of MTPC, subject to the license set forth in the following sentence. MTPC hereby grants to VIVUS a perpetual, irrevocable, fully paid, royalty-free, transferable, sublicenseable (through multiple tiers), non-exclusive license to use, disclose, copy, distribute, create derivative works of, practice, and otherwise exploit the REGULATORY FILE INFORMATION for any and all purposes; provided, VIVUS agrees that it shall (i) take reasonable measures to protect the secrecy of and avoid unnecessary disclosure and unauthorized use of the REGULATORY FILE INFORMATION and (ii) take at least those measures that it takes to protect its own confidential information and shall ensure that each THIRD PARTY granted access to the REGULATORY FILE INFORMATION are bound by confidentiality and non-use obligations with respect to such information. Notwithstanding the foregoing, nothing herein shall prevent VIVUS from disclosing the REGULATORY FILE INFORMATION to comply with applicable laws or regulations, including, without limitation, disclosures to regulatory agencies and courts or tribunals of competent jurisdiction.”
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