Articles – Page 2

Pre-Registration Consultation Meeting Material

The CHECKLIST is to be used for the preparation of a formal request to the office of the Chief Regulatory
Officer (CRO)/ South African Health Product Regulatory Authority (SAHPRA) for the purpose of the
meeting and should be submitted to the SAHPRA.

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Guideline for Professional Information for Human Medicines (Categories A and D)

Medicines | South Africa

This guideline describes following points;

Presentation Of Professional Information For Evaluation
Clinical Particulars
Qualitative And Quantitative Composition
Pharmaceutical Form
Pharmaceutical Particulars
Holder Of Certificate Of Registration

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Guideline for Patient Information Leaflet for Human Medicines (Categories A and D)

Medicines | South Africa

This guideline is to ensure that the PIL is written in clear and intelligible terms for the patient and is clearly legible.

This guideline describes the following points;

Requirements For Submission
Legibility Of The PIL
Format Of The PIL
Warnings and precautions

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Guidelines for Licence to Manufacture, Import Or Export

Medicines Medical Devices | South Africa

South African Health Products Regulatory Authority (SAHPRA) regulates medicines, scheduled
substances and medical devices for human and animal use, on behalf of the Department of Health and
in accordance with the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of
1965) and the relevant Regulations made thereunder. (Hereafter referred to as the Act or the
Medicines Act.)

This guideline describes the following points;

Manufacture And Packaging
Exemptions From A Licence To Manufacture, Import Or Export
How To Obtain A Licence Application Form And Information To Submit
Manufacturers’ Obligations

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Wholesalers to Export Medicinal Products

Medicines Medical Devices | South Africa

The aim of this Guideline is to assist wholesalers in the preparation of documentation for the application
to be licensed to export medicinal products Whenever there is doubt, wholesalers are advised to consult
South African Health Products Regulatory Authority (SAHPRA) for confirmation and/or clarification before
completing and submitting an application.

This guideline applies to all wholesalers who are intending to export medicinal products.

this guideline describes the following points;

Quality Management Systems
Requirements to be met By The Wholesaler Intending To Export
Requirements To Be Met By The HCR
Requirements To Be Met By The Foreign Site

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Guidelines on Inspections Involving The GMP Inspectors

Medicines | South Africa

South African Health Products Regulatory Authority (SAHPRA) is a statutory body, appointed by the Minister of Health to register medicines, and to ensure that these medicines are of quality, safe and efficacious. Medicines registered by SAHPRA, should, during their entire life cycle, comply with the information that has been evaluated and approved by SAHPRA.

All GMP inspections are carried out in accordance with the approved procedure to ensure compliance with the SA Guide to GMP, PIC/S guidelines on GMP, and WHO Guide to GMP.

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South African Good Wholesaling Practice for Wholesalers

Medicines | South Africa

Wholesaler distribution forms part of the supply chain of pharmaceutical products manufactured. Wholesalers are responsible for the effective, efficient and safe handling, storage, and distribution of such products ensuring the quality and identity of these during all aspects of the wholesaling and distribution process. This Guideline sets out appropriate steps for meeting this responsibility.

This guideline describes the following points;

Guiding Principles
Relevant Legislation
Contractual Activities, Service Level Agreements and TechnicalAgreements
Customer Verification
Vendor Verification
Organization and Management
Procurement for Wholesalers

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How to Respond to a GMP,GWP Or GCP Inspection Report

Medical Devices Medicines | South Africa

The South African Health Products Regulatory Authority (SAHPRA) regulates medicines, scheduled substances, and medical devices for human and animal use, in accordance with the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and
the relevant Regulations made thereunder. (Hereafter referred to as the Act or the Medicines Act.)

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Veterinary Medicines Clinical Guideline

Medicines | South Africa

This guideline describes the following points:

Part 4/CTD modules 2.4, 2.6 & 4: non-clinical pharmaco – toxicological data
Toxicological studies
Safety to users
Risk assessment of veterinary medicines
Part 5/CTD modules 2.5, 2.7 & 5: efficacy data

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Veterinary Medicines Exemptions from Certain Medicine Registration Requirements

Medicines | South Africa

This guideline is to clarify the provisions of the Act that allow for exemptions from certain requirements and to encourage applicants to register much-needed medicines for which the regulatory burden may be perceived as being too high e.g. minor use minor species.

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