Articles

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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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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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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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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Every applicant is required to report ADRs known to them involving their marketed medicines in accordance with the requirements of Act 101 of 1965 Regulation 40. The success of the Authority’s ADR reporting system depends on the quality, completeness, and accuracy of the information submitted. Reporting of ADRs and monitoring thereof, remain a viable means of identifying previously unrecognized, rare, or serious ADRs.

This guideline describes the following points;

  • Pharmacovigilance Obligations of The Holder Of A Certificate Of Registration/ Applicant
  • Adverse Drug Reaction Reports
  • Procedures for Reporting
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SAHPRA is mandated to regulate the safety, efficacy, and quality of all medicines. Prior to registration
of a medicine, access is usually limited to clinical trials authorized by the Authority. SAHPRA may,
in certain circumstances, and in accordance with Section 21 of the Act, authorize the sale of an
unregistered medicine for such purposes and in such manner and during such period as the
Authority may determine.

This guideline describes the following points;

  • Possible Access Scenarios
  • Roles and Responsibilities
  • Application Process
  • Evaluation Process
  • Record Keeping
  • Reporting

 

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