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CAMs Specified Substances 7.06 v2, Jun 2018
COMPLEMENTARY MEDICINES GUIDANCE ON SPECIFIED SUBSTANCES
Related Tags (New Search): Complementary medicines
ROADMAP FOR REGISTRATION OF COMPLEMENTARY MEDICINES
This document has been prepared to serve as a recommendation to applicants wishing to register complementary medicines for which claims of safety, quality and efficacy are being made and which have been called up for registration. It represents the Medicines…
Related Tags (New Search): Complementary medicines, Health supplements
Scheduling of Medicines (MCC: 2.36, Jun 2014)
This guideline provides applicant information for applicants on the scheduling of medicine submitted for registration. It includes a description of each of the 8 schedules and general guidelines for categorisation and for application scheduling of medicines.
Related Tags (New Search): Schedules
Veterinary Antimastitis Medicines (MCC: 3.13, Nov 2013)
This guideline provides information on the registration of veterinary anti-mastitis medicines. Circular 3.13
Related Tags (New Search): Veterinary medicine
Substitution of Medicines (MCC: 2.10, Apr 2010)
This guideline replaces the guideline on generic substitution published in 2003. It effectively cancels the list of not substitutable medicines. The only medicines declared to be not substitutable following this guideline of Biosimilars.
Related Tags (New Search): Biological medicines
Alcohol Content of Medicines (MCC: 2.03, Dec 2003)
Alcohol content of medicines intended for oral administration.
Wholesalers to Export Medicines (MCC: 4.10, Feb 2015)
Guidelines for the application for a license for Wholesalers wishing to export medicinal products. Circular 4.10
Related Tags (New Search): Exporters, Distributor, Wholesaler
Proprietary Names for Medicines (MCC: 2.15, Nov 2014)
The acceptability of proposed proprietary names of products submitted for registration as medicines.
Related Tags (New Search): Naming
Labeling of Medicines Containing Sugars (MCC: 2.35, Dec 2015)
The document provides guidance to applicants on how to label medicines containing “sugar” so as to alert prescribers and users who need to take cognisance of the presence of any sugar in the medicine and to take the necessary steps…
Related Tags (New Search): Application, Labeling
General Information (for veterinary medicines) (MCC: 3.01, Jan 2004)
Related Tags (New Search): Veterinary medicine
Package Inserts for Human Medicines (MCC: 2.16, Feb 2015)
The document provides recommendations to applicants regarding package inserts. 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 of third-party websites, and shall not be liable,…
Related Tags (New Search): Pack insert, Application
Roadmap for Registration of Complementary Medicines (MCC: 7.02, Dec 2013)
This guideline gives information to applicants wishing to register complimentary medicines for which claims of safety, quality and efficacy are being made and which have been called up for registration. It provides for implementation of Government Notice R870 of 15…
Related Tags (New Search): Complementary medicines, Application
Complementary Medicines – Health Supplements Safety and Efficacy (MCC: 7.04, Jun 2016)
This guideline provides information required for the application for registration of health supplements. The guideline provides details on compliance with GMP, GLP and good agricultural and collection practices. It also provides the format for the presentation of administrative information, common…
Related Tags (New Search): Health supplements, Vitamins & Minerals, Safety and performance, Application, Efficacy, CTD
Guidelines for Recall/Withdrawal of Medicines (MCC: 5.07, Dec 2008)
This document provides information on the record of medicines and covers notification for initiations of a recall, information required for assessment of a recall, classification, communications and procedures.
Related Tags (New Search): Recalls
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
Complementary Medicines – Registration Application ZA-CTD - Quality (MCC: 7.05, Jun 2016)
This guideline provides information required for the submission of an application for registration of a complimentary medicine. The guideline gives details on the administrative information, common technical document summaries and quality information required for a registration application.
Related Tags (New Search): Complementary medicines, Health supplements, Application
General Information: Complementary and Alternative Medicines Submissions (MCC: 9.37, Jan 2011)
General Information: Complementary and Alternative Medicines Submissions in response to Government Notice of 22nd February 2002
Related Tags (New Search): Complementary medicines
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
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): Exemptions, Veterinary 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 insert, Application
Guidelines for Parallel Importation of Medicines in South Africa (MCC: 5.02, Jun 2003)
Guidelines for Parallel Importation of Medicines in South Africa
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 performance, GCP, Veterinary medicine
Guidelines for the Importation and Exportation of Medicines (MCC: 5.01, Jun 2011)
Guidelines for the Importation and Exportation of Medicines
Guidelines for the Destruction of Schedule 6 Medicines and Substances (MCC: 5.06, May 2003)
This document provides recommendations to applicants wishing to destroy any schedule 6 medicines and or substances.
SA GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINES (v6, MCC: 4.01, Dec 2017)
Guide to Good Manufacturing Practice for Medicines in South Africa, Circular 4.01
Guide to Good Manufacturing Practice for Medicines in South Africa (MCC: 4.01, Nov 2010)
Guide to Good Manufacturing Practice for Medicines in South Africa. Circular 4.01
Related Tags (New Search): GMP
Guidelines for the Destruction of Schedule 5 Medicines and Substances (MCC: 5.05, May 2003)
This document provides recommendations to applicants wishing to destroy schedule 5 medicines and or substances
Guidelines for Recall/Withdrawal of Medicines, Medical Devices and IVDs (MCC: 5.07, Nov 2015)
This is a draft guideline incorporating medical devices. Not yet finalised
Related Tags (New Search): GMP, QMS, IVDs, Non-compliance, Recall, Recalls, Safety, Adverse Drug Reaction, SRPINS, Adverse Drug Event
POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA (MCC: June 2017)
Post-Marketing Reporting of Adverse Drug Reactions to Human Medicines in South Africa
Related Tags (New Search): Allopathic medicines, Complementary medicines, Safety, Adverse Drug Reaction, SRPINS, Adverse Drug Event, Post-marketing
Guideline for the Direct Transmission of Fees Payable to the Registrar Of Medicines (MCC: 17.02, Jul 2009)
This guideline has been prepared to serve as a guideline to enable the direct payment of fees into the bank account of the Medicines Control Council and must be read together with the Guideline on Fees Payable to The Registrar…
Related Tags (New Search): Guidelines