Transcription of Medicines Control Council : General Information
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Medicines Control Council : General Information
Registration of Medicines General Information General Information Feb08 April 2008 Page 1 of 48 Medicines Control Council General Information This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Medicines . It represents the Medicines Control Council s current thinking on the safety, quality and efficacy of Medicines . It is not intended as an exclusive approach. Council reserves the right to request any additional Information to establish the safety, quality and efficacy of a medicine in keeping with the knowledge current at the time of evaluation.
Registration of Medicines General Information 2.01 General information Feb08 v4.doc April 2008 Page3 of 48 GUIDELINES FOR THE REGISTRATION OF …
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