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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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The lot release of human vaccines by the South African National Control Laboratory for Biological
Products are performed within the framework of the Medicines and Related Substances Act, 1965 (Act
No. 101 of 1965) as amended and Act 14 of 2015, regulations 15(1) and 15(2).

This guideline should be read together with the latest National Control Laboratory (NCL) circular on
General Information Regarding Vaccines and Lot Release, which is available on request at
(NclFHS@ufs.ac.za)

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This guidance document is to describe the procedures involved in the scheduling and conduct of Pre-Registration Consultation (PRC) meetings between the Office of the CRO of the SAHPRA and the applicant/sponsor of biological medicines. The primary purpose of the meetings is to address issues relating to the development of a product in the planning phase of such products.

This guideline describes the following points;

  • Terms, Definitions, and Abbreviations
  • Types of PRC Meetings
  • Procedure for Request To Schedule Meetings
  • Pre-Registration Consultation Meeting Material
  • Cancellation of Meeting

 

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