Transcription of Additional guidance on documents relating to an …
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Additional guidance on documents relating to an …
7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8545 E-mail Website European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged. 20 September 2012 EMA/CHMP/CVMP/QWP/549010/2012 Committee for Medicinal Products for Human Use (CHMP) Additional guidance on documents relating to an active substance master file Additional guidance on completing the Annex 2-letter of access, Annex 3-submission letter and administrative details for documents relating to an active substance master file and Annex 4-withdrawal of access letter of the active substance master file procedure guidance (CHMP/QWP/227/02 Rev 3, EMEA/CVMP/134/02 Rev 03) Introduction and general comments The main objective of the active Substance Master File (ASMF) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or 'know-how' of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the Applicant or Marketing Authorisation (MA)
Additional guidance on documents relating to an active substance master file EMA/CHMP/CVMP/QWP/549010/2012 Page 4/10 . Submission Letter . The name of the active substance and the EU/ASMF reference number (when available) or national
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