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.
decentralised procedure (hereafter “the coordination group”). The applicant cannot stop this procedure by subsequently withdrawing the application in the referring Member State. If no agreement can be reached in this group the matter is referred for arbitration to the EMEA. Any matter dealt with by the coordination group in a
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