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South Africa: MCC Released Safety- Related Package Insert Notifications Guidance

Friday, August 04, 2017: The Medicines Control Council (MCC) of South Africa has released guidance intended to provide information to applicants wishing to submit applications regarding safety and safety-related amendments to the package insert of a registered medicine by notification process. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines. 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. The MCC is committed to ensure that all registered medicines will be of the required quality, safety and efficacy. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.

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