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This guideline supplements the guideline on oversight and monitoring of clinical trials to clarify and define the rules of investigators in investigational studies of medical products.

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Post-Marketing Reporting of Adverse Drug Reactions to Human Medicinal Products in South Africa (MCC: 2.33, Sept 2016)

The document assist the reporting of adverse drug reactions (ADRs) and in the management of safety data during post-registration and post-marketing clinical trials. To confirm that you have the latest version of this document, please visit:

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General Regulations

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Licence to Application to Act as Wholesaler or Distributor (MCC: 6.11, Mar 2009)

Licence Application to act as Wholesaler or Distributor. Circular 6.11

Related Tags (New Search): LicensingDistributorWholesalerMedicines

Licence Application to Manufacture, Import or Export medicine (MCC: 6.10, Mar 2009)

Licence Application to Manufacture, Import or Export medicine. Circular 6.10

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Guidelines for Licence to Manufacture, Import or Export (MCC: 16.01, Feb 2004)

Recommendations for an application for a licence to manufacture, import or export medicines and medical devices. GWP guidelines apply.

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