EMA 与活性物质主文件相关的指南 2012.9.20 英文.pdfVIP

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) holder to take full responsibility for the medicinal product, and the quality and quality control of the active substance. National Competent Authorities (NCA) / European Medicines Agency (EMA) thus have access to the complete information that is necessary for an evaluation of the suitability of the use of the active substance in the medicinal product. This document is intended to provide additional guidance for ASMF holders on completing the Annex 2- Letter of Access, the Annex 3-Submission Letter and Administrative Details for Documents relating to an Active Substance Master File (referred to as the Submission Details Form throughout this document), and the Annex 4-Withdrawal of Access Letter of CPMP/QWP/227/02 Rev 3/ EMEA/CVMP/134/02 Rev 3 Guideline on Active Substance Master File Procedure. Therefore, this document should be read in conjunction with the guideline. It is intended to update this document, as and when required. This additional guidance will also be useful information for MA holders. The objective of the aforementioned Annexes is to assist NCA/EMA identi