Volume 2C - Regulatory guidelines: related to procedural and regulatory requirements, e.g.Volume 2B - Presentation and content of the dossier: provides guidance for the compilation of dossiers for applications for marketing authorisation, and is applicable for the centralised procedure and national procedures, including mutual-recognition and decentralised procedures.Chapter 6 – Community marketing authorisation.Volume 2A - Procedures for marketing authorisation:.Volume 1 – Pharmaceutical legislation, contains most of the relevant Directives, Regulations, decisions and communications.The rules governing medicinal products in the European Union concerning medicinal products for human use is published on the European Union website: Information about the hierarchy of the European Union texts can be found in annex I to Procedures for marketing authorisation“, The Rules governing Medicinal Products in the European Union, Volume 2A, Notice to Applicants, Chapter 1. To exercise the Union's competences, the institutions may adopt regulations, directives, decisions, recommendations and opinions.
The treaties on which the European Union and the European Communities are founded are available.
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