in Search , Health Products, SAHPRA/MCC Circular (clear all)
Showing 1 to 30
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 performance, GCP, Veterinary 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 medicines, Safety and performance, Safety, Veterinary 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): Recalls, Adverse Drug Reaction, Adverse Drug Event, 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
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 devices, IVDs, Safety and performance, Application
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): Licencing, Medical devices, IVDs, Importers, Wholesaler, Manufacturers
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 medicines, Complementary medicines, Safety, Adverse Drug Reaction, SRPINS, Adverse Drug Event, Post-marketing
CLASSIFICATION of MEDICAL DEVICES and IVDs: (MCC: July 17)
Classification of Medical Devices and IVDs
Related Tags (New Search): Medical devices, IVDs, Classification
CAMs Specified Substances 7.06 v2, Jun 2018
COMPLEMENTARY MEDICINES GUIDANCE ON SPECIFIED SUBSTANCES
Related Tags (New Search): Complementary medicines
Conformity assessment procedures – medical devices and IVDs (MCC: 8.03, Sept 2016)
Conformity assessment procedures – medical devices and IVDs
Related Tags (New Search): Medical devices, IVDs, Safety and performance, Application, Quality
Classification of medical devices and IVDs (MCC: 8.05, Aug 2016)
Classification of medical devices and IVDs
Related Tags (New Search): Medical devices, IVDs, Classification
Application for Registration of a Veterinary Medicine – Administrative Data (MCC: 6.0, May 2003)
Application for registration of a veterinary medicine. Data required for the administrators part of the application. Circular 6.0
Related Tags (New Search): Licensing, Veterinary medicine
MRLS and Withdrawal Periods (MCC: 3.07, Jan 2004)
This guideline provides information on maximum residue levels (MRLS) and withdrawal periods for veterinary medicines in food animals. Circular 3.07
Related Tags (New Search): Veterinary medicine
Guideline on Veterinary Drug Adverse Events (MCC: 3.09, Jan 2004)
This guideline provides information on the reporting and management of adverse events with veterinary medicines. Circular 3.09
Related Tags (New Search): Safety and performance, Recalls, Veterinary medicine
Veterinary Orphan Products (MCC: 3.12, May 2012)
This guideline provides information on the registration of veterinary orphan products in South Africa. Circular 3.12
Related Tags (New Search): Veterinary medicine
Patient Information Leaflets (PILs) (MCC: 2.14, Feb 2016)
The document provides recommendations to applicants regarding patient information leaflets 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): Patient Information Leaflet, Application
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
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): Safety, Adverse Drug Reaction, Clinical trials, Medicines
Implementation of the Post-Registration Amendments Guideline (MCC: 2.13, Dec 2003)
Format for the submission of Post-Registration Amendments.
Complementary Medicines: Right to Sale (MCC: 9.72, Apr 2016)
Publication of Complementary Medicines (Category D) Submitted for Registration terms of Section 14(3) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Please note that this is a third-party website. Juta has no control over the nature,…
Related Tags (New Search): Complementary medicines
RECALL, ADVERSE EVENT and POST-MARKETING VIGILANCE REPORTING of MEDICAL DEVICES and IVDs (MCC 8.04, Aug 17)
Guidelines on the recall, adverse event reporting and post-marketing vigilance of medical devices and IVDS in South Africa
Related Tags (New Search): Medical devices, IVDs, Recalls
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 devices, Biological medicines, 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
Section 21 Authorisation of Sale of Unregistered Medical Devices (V1, MCC: 9.105, Sep 2017)
Section 21 Authorisation of Sale of Unregistered Medical Devices
Related Tags (New Search): Medical devices, Clinical trial
Exemption of Medical Devices and IVD's from the provisions of sections 18A, 18B and 22G (MCC, 5 Dec 2017)
Exemption of Medical Devices and IVD's from the provisions of sections 18A, 18B and 22G of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended
Related Tags (New Search): Medical devices, IVDs, Exemptions, Marketing code, Bonussing, Sampling
MCC Resolution to rescind call-up (2002) of complementary medicines
The call-up notice R204, Gazette No 23128 of 22nd February has been rescinded by resolution published in Gazette 40637 of 24 February 2017.
Related Tags (New Search): Complementary medicines
Pre-registration Consultation Meeting (MCC: 2.39, Mar 2015)
This document provides guidance on the procedures involved in the scheduling and conduct of pre—registration consultation meetings in respect of applications for biological medicines. It focuses on issues relating to the development of biological medicines in the planning phase of…
Related Tags (New Search): Biological medicines, Application