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.
products must use the procedure foreseen in the Variations Regulation2.In addition, variations to “ex-concertation” medicinal products authorised by Member States following an opinion of the Committee for Human Medicinal Products (CHMP) given before 1st January 1995 are required to use the mutual recognition procedure. These
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