in Tag: Application  (clear all)


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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

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

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

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

South African Specification for eCTD Regional - Module 1 (MCC: 2.21, Mar 2013)

South African Specification for eCTD Regional - Module 1

Related Tags (New Search): Application

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

eCTD Checksums (MCC: 2.27, Feb 2013)

Links

Related Tags (New Search): Application,   eCTD

Questions and Answers – Implementation of eCTD in South Africa (MCC: 2.28, Feb 2016)

Abbreviations, acronyms, technical and format related questions.

Related Tags (New Search): Application,   eCTD

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

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

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

Electronic submission of Clinical Trial Documents (Amendments, Bioequivalence Studies and Responses) (MCC: 9.59, Jun 2015)

Guideline provides detailed in the Electronic submission process of application for clinical trial.

Related Tags (New Search): Application,   Clinical trial

South African eCTD Validation Criteria (MCC: 2.22, Mar 2013)

South African eCTD Validation Criteria

Related Tags (New Search): Application

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

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

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 (MCC: 2.01,Aug 2012)

This guideline provides a general overview on what is required of an applicant for a medicine registration. It covers details that need to be submitted to the Authority.

Related Tags (New Search): Application

Guidance for the submission of the South African CTD/eCTD – General and Module 1 (MCC: 2.24, Aug 2012)

Guidance for the submission of the South African CTD/eCTD – General and Module 1

Related Tags (New Search): Application