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Guidelines for the Importation and Exportation of Medicines (MCC: 5.01, Jun 2011)

Guidelines for the Importation and Exportation of Medicines

Related Tags (New Search): ExportersImporters

Scheduling of Substances for Prescribing by Authorised Prescribers (MCC: 2.37, Apr 2014)

Document is intended to provide applicants with information and guidance on the criteria and policies for evaluating applications for an amendment to the schedule.

Related Tags (New Search): Schedules

Bioavailability and Bioequivalence of Veterinary Medicines (MCC: 3.03, Jan 2004)

Bioavailability and Bioequivalence of Veterinary Medicines. Secular 3.03

Related Tags (New Search): Veterinary medicine

Efficacy of and GCP for Veterinary Medicines (MCC: 3.04, Jun 2003)

This documents provides guidelines on the conduct of clinical trials on veterinary medicines including requirements for safety, quality and efficacy. Circular 3.04

Related Tags (New Search): Veterinary medicine

Guideline on Preclinical Safety Studies for Veterinary Medicines (MCC: 3.05, Jan 2004)

Guideline on Preclinical Safety Studies for Veterinary Medicines. Secular 3.05

Related Tags (New Search): Safety and performanceGCPVeterinary medicine

Safety of Veterinary Biologicals (MCC: 3.08, Jan 2004)

This guideline provides information on the safety aspects of veterinary biological medicines. Circular 3.0 H

Related Tags (New Search): Biological medicinesSafety and performanceSafetyVeterinary medicine

Veterinary Drug Recalls (MCC: 3.10, Jan 2004)

This guideline provides information on the recall of veterinary medicines. Circular 3.10

Related Tags (New Search): RecallsAdverse Drug ReactionAdverse Drug EventVeterinary medicine

Aerosol Manufacturing (MCC: 4.03, Jun 2003)

Specific GMP guidelines on the manufacture of aerosol – based medicines. Circular 4.03

Related Tags (New Search): GMP

Cephalosporin Manufacturing (MCC: 4.05, Jun 2003)

Specific GMP guidelines on the manufacture of cephalosporin - containing medicines circular 4.05

Related Tags (New Search): GMP

Radiopharmaceutical Manufacturing (MCC: 4.07, Jun 2003)

Pacific GMP guidelines on radiopharmaceutical manufacturing. Circular 4.07

Related Tags (New Search): GMP

Guidance for the Submission of regulatory Information in eCTD Format (MCC: 2.23, Mar 2013)

Guidance for the Submission of regulatory Information in eCTD Format

Related Tags (New Search): Application

Pharmaceutical and Analytical CTD/eCTD (MCC: 2.25, Aug 2014)

Pharmaceutical and Analytical CTD/eCTD

Multiple Submissions of the Same Application for Registration with Different Proprietary Names (MCC: 2.40, Dec 2015)

Multiple Submissions of the Same Application for Registration with Different Proprietary Names

Related Tags (New Search): Application

Licence Application to Manufacture, Import, Distribute or Export Medical Devices (MCC: 6.21, Aug 2016)

Licence Application to Manufacture, Import, Distribute or Export Medical Devices

Related Tags (New Search): Medical devicesIVDsApplicationExportersImportersDistributorManufacturers

Medical Devices and IVDs - Essential Principles of Safety and Performance (MCC: 8.02, Jul 2016)

Medical Devices and IVDs - Essential Principles of Safety and Performance

Related Tags (New Search): Medical devicesIVDsSafety and performanceApplication

Council's Responsibilities and Liability When Performing Its Function in Terms of Section 21 of Act 101 of 1965 (MCC 6.12, January 2013)

The authorisation of the use of unregistered medicine under section 21 of the Medicines and Related Substances Act 101 of 1965. For more information, go to www.mccza.com Please note that this is a third-party website. Juta has no control over the…

Related Tags (New Search): Application

Guideline for Completion of Annual Returns Form (MCC: 5.03, Jun 2003)

Manufacturers are required to submit annual returns for narcotic and psychotropic substances, scheduled III preparations and uncontrolled substances. These guidelines pertain to the submission.

Related Tags (New Search): S6Specified S5PermitsS7S8

POSITION STATEMENT: TRANSITIONAL ARRANGEMENTS FOR MEDICAL DEVICES (MCC 9.96, JUN 2017)

Please note that this is a third-party website. Juta has no control over the nature, content or availability of third-party websites, and shall not be liable, in any manner whatsoever, for any damages incurred through the use of third-party websites.

Related Tags (New Search): LicencingMedical devicesIVDsImportersWholesalerManufacturers

Section 21 Applications for Unregistered Veterinary Medicines (MCC: 3.11, Jan 2004)

This guideline provides information on the application for use of unregistered veterinary medicines. Circular 3.11

Related Tags (New Search): ExemptionsVeterinary medicine

Package Inserts for Human Medicines Standard texts (MCC: 2.20, Mar 2016)

The document indicates standardised texts or wording that must be included into package inserts for certain medicines. For more information, go to www.mccza.com Please note that this is a third-party website. Juta has no control over the nature, content or availability…

Related Tags (New Search): Pack insertApplication

SAFETY-RELATED PACKAGE INSERT NOTIFICATIONS (SR-PINs) - (MCC: Aug 17)

Safety-related Package Insert Notifications (SR PINS) in South Africa.Circular 2.17.

Related Tags (New Search): Allopathic medicinesComplementary medicinesSafetyAdverse Drug ReactionSRPINSAdverse Drug EventPost-marketing

CLASSIFICATION of MEDICAL DEVICES and IVDs: (MCC: July 17)

Classification of Medical Devices and IVDs

Related Tags (New Search): Medical devicesIVDsClassification

NOTIFICATION STUDIES: PHASE IV (MCC, May 17)

Template for the notification with respect to conducting of phase 4 (post-marketing) studies on medicines in South Africa. Circular 6.24

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