Transcription of VOLUME 2A Procedures for marketing authorisation CHAPTER …
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VOLUME 2A Procedures for marketing authorisation CHAPTER …
_____Chap ter 2 Mutual Recognition 1 EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, ENTR/F2/ SM(2007) Revision 5 NOTICE TO APPLICANTS VOLUME 2A Procedures for marketing authorisation CHAPTER 2 Mutual Recognition February 2007 This CHAPTER 2 Mutual Recognition will be included in The Rules governing Medicinal Products in the European Community The Notice to Applicants VOLUME 2A Procedures for marketing authorisation _____Chap ter 2 Mutual Recognition 2 CHAPTER 2 Mutual recognition procedure and decentralised procedure February 2007 1. LEGAL BASIS AND PURPOSE The legal provisions covering the mutual recognition procedure and the decentralised procedure for human medicinal products are contained in Directive 2001/83/EC. Both the mutual recognition procedure and the decentralised procedure aim at facilitating access to a single market by relying upon the principle of mutual recognition.
• special, simplified registration of traditional herbal medicinal products which are not falling within the scope of Article 16d(1), cf. Article 16g(1) of Directive 2001/83/EC • products falling within the transitional arrangements for Cyprus, Lithuania, Malta, Poland and Slovenia upon their accession to the EU, cf. the Act of Accession4.
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