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)
Additional guidance on documents relating to an active substance master file EMA/CHMP/CVMP/QWP/549010/2012 Page 2/10 . When should each …
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