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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: http://www.mccza.com

Related Tags (New Search): SafetyAdverse Drug ReactionClinical trialsMedicines

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

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

Related Tags (New Search): LicensingWholesalerManufacturersMedicines

CLINICAL TRIAL INVESTIGATORS: (MCC 2.47 V.2, May 2017)

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.

Related Tags (New Search): Medical devicesBiological medicinesMedicines

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.

Related Tags (New Search): InspectionsGWPInspectionsComplementary medicinesMCC InspectionsLicensingApplicationFeesExportersImportersManufacturersMedicines

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

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

Related Tags (New Search): LicensingWholesalerManufacturersMedicines

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