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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
Medicine Donations to South Africa (MCC: 5.08, Sept 2010)
Medicine Donations to South Africa
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 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
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
Ethics in Health Research: Principle, Process and Structure
National guidelines on ethics in health research including principles, process and structure for requirements for the ethical conduct of clinical trials.
Related Tags (New Search): GCP, Clinical trial
WHO International Health Regulations 2005
WHO International Health Regulations 2005. 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…
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
BOOKLET 3: NATIONAL PATIENTS’ RIGHTS CHARTER
The Patient rights charter outlines a patents rights and responsibilities with respect to health care. 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…
Related Tags (New Search): HPCSA
Dispensing Fees for Authorised Prescribers: GN 1589 in GG 40515
Dispensing Fees for Authorised Prescribers
Related Tags (New Search): Fees
MEDICINES AND RELATED SUBSTANCES AMENDMENT ACT 72 OF 2008, Proc 20 in GG 40869 of 26 May 2017
Amends ss. 1, 15C, 22A, 22C, 22E, 22F, 22H, 28, 29, 30, 31, 34A & 35; repeals ss. 5 to 9 inclusive & 12; inserts s. 24A; and substitutes ss. 2-4, 13-15, 15A,15B, 16-22, 22B, 22D, 23-27, 33A, 36 &…
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
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): S6, Specified S5, Permits, S7, S8
BOOKLET 4: SEEKING PATIENTS’ INFORMED CONSENT: THE ETHICAL CONSIDERATIONS
HPCSA guidelines on seeking patients informed consent. Principles of good practice which all healthcare practitioners are expected to follow when seeking patients informed consent to investigations, treatment screening or research. Please note that this is a third-party website. Juta has…
Related Tags (New Search): HPCSA, Informed Consent
Exclusion of Certain Medicines from the Operation of the Medicines and Related Substances Act 101 of 1965 (GN 565 in GG 40015 of 25 May 2016)
Exclusion of Certain Medicines from the Operation of the Medicines and Related Substances Act 101 of 1965 (GN 565 in GG 40015 of 25 May 2016)
Related Tags (New Search): S0
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
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