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South Africa: GUIDELINES FOR THE REGISTRATION OF MEDICINES

Medicines Control Council (MCC), Department of Health Republic of South Africa (2012) C1
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.
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Zambia: GENERAL GUIDELINES FOR SUBMITTING APPLICATIONS FOR REGISTRATION OF A MEDICINE

Zambia Medicines Regulatory Authority (ZAMRA) (2016) C2
First Edition