Transcription of VOLUME 2A Procedures for marketing authorisation …
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VOLUME 2A Procedures for marketing authorisation …
1 EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Health systems and products Medicinal products Revision 11 NOTICE TO APPLICANTS VOLUME 2A Procedures for marketing authorisation CHAPTER 1 marketing authorisation July 2019 This Chapter 1 marketing authorisation will be included in The Rules governing Medicinal Products in the European Union The Notice to Applicants VOLUME 2A Procedures for marketing authorisation 2 CHAPTER 1 marketing authorisation CHAPTER 1 marketing authorisation .. 2 1. 3 Objectives .. 3 Status .. 3 2. marketing 4 National authorisations .. 6 Union authorisations .. 6 Notion of global marketing authorisation .. 8 Validity of the marketing authorisation .. 10 Name of a medicinal product .. 12 Transparency .. 13 Multiple applications .. 13 Concept of "applicant" and " marketing authorisation holder" .. 14 3. marketing authorisation Procedures .. 15 Centralised procedure .. 15 Decentralised procedure and mutual recognition procedure.
1 OJ L 136, 30.4.2004, p.1. 2 OJ L 331, 28.11.2001, p. 67. 3 Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance, OJ L 299 of 27.10.2012, p. 1 and Regulation
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