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Registration of MEDICINES general information 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. Alternative approaches may be used but these should be scientifically and technically justified.
Registration of Medicines General Information 2.01_General_information_Jul12_v8_showing_changes.docx PageAugust 2012 1 of 34 MEDICINES CONTROL COUNCIL GENERAL INFORMATION
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Medicines Control Council : General Information, Medicines General Information, General information, MEDICINES CONTROL COUNCIL GENERAL INFORMATION, MEDICINES CONTROL COUNCIL, Information, Medicines, Uniform Recall Procedure for Medicines, REVIEW OF WORLD PHARMACOPOEIAS, General, SA CODE OF MARKETING PRACTICE, Control, MEDICINES AND RELATED SUBSTANCES ACT