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.

marketing authorisation in a Member State, the applicant/marketing authorisation holder must submit an application in the Member States concerned using the procedure of mutual recognition. The Member States concerned should then recognise the marketing authorisation already granted by the reference Member State and

Tags:

  Applications, Marketing, Authorisation, Marketing authorisation, For marketing authorisation

Information

Related search queries