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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

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

Licence Application to Manufacture, Import, Distribute or Export Medical Devices (MCC: 6.21, Aug 2016)

Licence Application to Manufacture, Import, Distribute or Export Medical Devices

Related Tags (New Search): Medical devicesIVDsApplicationExportersImportersDistributorManufacturers

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 devicesIVDsSafety and performanceApplication

Council's Responsibilities and Liability When Performing Its Function in Terms of Section 21 of Act 101 of 1965 (MCC 6.12, January 2013)

The authorisation of the use of unregistered medicine under section 21 of the Medicines and Related Substances Act 101 of 1965. For more information, go to www.mccza.com Please note that this is a third-party website. Juta has no control over the…

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 insertApplication

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

eCTD Checksums (MCC: 2.27, Feb 2013)

Links

Related Tags (New Search): ApplicationeCTD

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): ApplicationeCTD

Licence Application to Import, Distribute or Export Medical Devices (MCC: 6.22, Nov 2016)

Licence Application to Import, Distribute or Export Medical Devices

Related Tags (New Search): Medical devicesIVDsApplicationExportersImportersDistributor

Conformity assessment procedures – medical devices and IVDs (MCC: 8.03, Sept 2016)

Conformity assessment procedures – medical devices and IVDs

Related Tags (New Search): Medical devicesIVDsSafety and performanceApplicationQuality

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 LeafletApplication

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 insertApplication

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 medicinesApplication

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 medicinesApplication

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 supplementsVitamins & MineralsSafety and performanceApplicationEfficacyCTD

Application for Registration of a Medicine, Module 1: Administrative Information Application Form (MCC: 1.2.1, Aug 2014)

Application for registration of a medicine, Module 1: Administrative Information Application Form

Related Tags (New Search): Application

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

South African eCTD Validation Criteria

Related Tags (New Search): Application

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): ApplicationClinical trial

Application for Registration of a Medicine (MCC: 6.01, Dec 2003)

Application for Registration of a Medicine

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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 medicinesHealth supplementsApplication

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 medicinesComplementary medicinesLicensingApplicationManufacturers

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.

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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

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): ApplicationLabeling

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): InspectionsGWPInspectionsComplementary medicinesMCC InspectionsLicensingApplicationFeesExportersImportersManufacturersMedicines