MEDICINES CONTROL COUNCIL - mccza.com

Registration of MEDICINES Scheduling of MEDICINES June 2014 Page 1 of 20 Back to ToC MEDICINES CONTROL COUNCIL SCHEDULING OF MEDICINES This guideline is intended to provide guidance to applicants on the scheduling of substances submitted for registration as MEDICINES . It represents the MEDICINES CONTROL COUNCIL s current thinking on the safety, quality and efficacy of MEDICINES and takes into account the country s obligations in terms of international agreements. It is not intended as an exclusive approach. COUNCIL reserves the right to request any additional information to establish the scheduling status 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. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.

This guideline is intended to provide to applicants on the scheduling of substances submitted for registration guidance as medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines and

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