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South Africa's (SAPHRA): Renewal Of Human Medicines Requirements and Process

Earlier today (09 June, 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated guideline on "Renewal of Human and Veterinary Medicines Requirements and Process".

Several aspects of the registered medicinal product may significantly change during the course of five (5) years.

It is important to renew registration as these collective changes may significantly impact the product's quality, safety and efficacy.

The renewal process will ensure that the product remains safe, effective, and of good quality for continued public use.

This guideline outlines the steps required from submission of the renewal application to the outcome, the timeframe, and procedures by which the Authority can amend the conditions of renewal of registration when necessary.

There are three major parts of this guideline that address:

  • the general requirements and application procedures for human and veterinary medicinal products;

  • the processing of applications; and

  • the technical requirements for applications for renewals.

Renewal applications should be made to the Authority at least six (6) months before the expiry of the validity of registration of a particular medicinal product.

No variations will be accepted as part of the renewal of registration as this will impact the processing and swift turn-around of renewals. Variations to a registered pharmaceutical product shall be made in accordance with the requirements stipulated in the Variations Addendum and relevant variation guidelines.

To know more about the requirements and renewal procedure click this LINK.


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