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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

International Metric System (SI) (MCC: 2.38, Jun 2014)

The International Metric system (SI) applies to Medicines Registration applications

Related Tags (New Search): Licensing,   Labeling

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

Backlog Action Plan (MCC: 9.77, Aug 2016)

Notice to the pharmaceutical industry on process for addressing the backlog in evaluation of registration applications. Dossier is will be reviewed by work groups attending 2 different categories of document.

Related Tags (New Search): Allopathic medicines,   Complementary medicines,   Licensing,   Application,   Manufacturers

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): Inspections,   GWP,   Inspections,   Complementary medicines,   MCC Inspections,   Licensing,   Application,   Fees,   Exporters,   Importers,   Manufacturers,   Medicines

Draft Dispensing Fee for Pharmacists

Draft Dispensing Fee for Pharmacists

Related Tags (New Search): Dispensing,   Fees

IBP Draft Methodology — GN 1053 in GG 31369 of 29 August 2008

IBP Draft Methodology - Call for Comment on a Methodology for International Benchmarking for Originator Medicine Prices. For more information, go to http://www.gpwonline.co.za Please note that this is a third-party website. Juta has no control over the nature, content or availability of…

Related Tags (New Search): benchmark pricing,   Notices

Interim SEP increase Government Gazette, No. 40188, 5 August 2016

Interim SEP increase 2016

Related Tags (New Search): Regulations

Draft Dispensing Fee for Pharmacists — GN 895 of 5 August 2016

Regulations relating to a transparent pricing system for medicines and scheduled substances: (Draft dispensing fee for pharmacists). For more information, go to http://www.gpwonline.co.za Please note that this is a third-party website. Juta has no control over the nature, content or availability of…

Related Tags (New Search): Dispensing,   Regulations

BOOKLET 13: GENERAL ETHICAL GUIDELINES FOR HEALTH RESEARCHERS

HPCSA guidelines for health researchers are applicable to research institutions, organisations and researchers registered with the HPCSA. 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…

Related Tags (New Search): HPCSA,   Informed Consent

BOOKLET 14: GENERAL ETHICAL GUIDELINES FOR BIOTECHNOLOGY RESEARCH IN SOUTH AFRICA

HPCSA general ethical guidelines for Biotechnology research. 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…

Related Tags (New Search): HPCSA

BOOKLET 15: RESEARCH, DEVELOPMENT AND USE OF CHEMICAL AND BIOLOGICAL WEAPONS

HPCSA guidelines for research, development and use of chemical and biological weapons. 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…

Related Tags (New Search): HPCSA

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

BOOKLET 10: GENERAL ETHICAL GUIDELINES FOR GOOD PRACTICE IN TELEMEDICINE

HPCSA a guideline for protecting and providing information. 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…

Related Tags (New Search): Record keeping,   HPCSA

BOOKLET 8: GENERAL ETHICAL GUIDELINES FOR REPRODUCTIVE HEALTH

HPCSA guidelines for reproductive health address violence against women, contraception, sterilization, abortion sex selection, surrogate motherhood, collection of cord blood. Please note that this is a third-party website. Juta has no control over the nature, content or availability of third-party…

Related Tags (New Search): HPCSA

BOOKLET 9: GUIDELINES ON THE KEEPING OF PATIENT RECORDS

HPCSA guidelines on the keeping of patient records. The guidelines are applicable to practitioners in the public and private sector. Please note that this is a third-party website. Juta has no control over the nature, content or availability of third-party…

Related Tags (New Search): Record keeping,   HPCSA

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

The Advertising and Marketing Industry – Code of Practice (GenN 449 in GG 40159 of 26 July 2016)

To make allowance for alternate dispute resolution for complaints lodged by the general public with the Advertisings Standards Authority of South Africa. Please note that this is a third-party website. Juta has no control over the nature, content or availability…

Related Tags (New Search): Advertising,   Marketing code,   Consumer advertising,   Promotion

Transparent Pricing System for Medicines and Scheduled Substances: Dispensing Fee for Pharmacists (GN 153 in GG 39658 of 5 February 2016)

Transparent Pricing System for Medicines and Scheduled Substances: Dispensing Fee for Pharmacists. For more information, go to http://www.gpwonline.co.za 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…

Related Tags (New Search): Dispensing

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

Efficacy of Veterinary Biologicals (V 1, MCC: 3.06, Jan 2004)

This guideline provides information to applicants wishing to submit data as evidence of efficacy for veterinary biological medicines

Related Tags (New Search): Biological medicines,   Veterinary medicine,   Efficacy,   Clinical trial

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

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

Request for clarity regarding the Complementary and Alternative Medicines (CAMS) – Right of Sale Notice (GN R870 in GG 31334 of 22 August 2008)

Request for clarity regarding the Complementary and Alternative Medicines (CAMS) – Right of Sale Notice: GG Notice R.870. 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…

Related Tags (New Search): Complementary medicines

Reporting Adverse Drug Reactions in South Africa (MCC: 2.11, Dec 2012)

This guideline apply to the reporting of serious adverse event of medicine reported during clinical trial. It does not apply to the reporting of post-marketing adverse drug reaction. Refer to guideline 2.33 for the reporting of post-marketing adverse reactions to…

Related Tags (New Search): Clinical trials

Emergency Procedures for Clinical Trial Tests (MCC: 2.41, Oct 2016)

This document outlines the requirements for emergency standard operating procedures which need to be in place during the conduct of clinical trial. It includes the minimum requirements for emergency procedures.

Related Tags (New Search): GCP,   Clinical trial

(Showing 1 to 30 of 301 results)