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South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1

Recently (18 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Application form template "Medicines Application Form Module 1.2.1", which should be included in the South African Common Technical Document – Module 1 Administrative Information effective from

Module 1.2.1 of the eCTD is an important component of the application that contains specific information related to the applicant and the application itself.

This section includes crucial administrative and prescribing information about the medicine being submitted for regulatory approval.

This module serves as the foundation for the application, providing the necessary details for SAHPRA to identify and assess the submitted medicine accurately.

The Application form captures important details such as the applicant's information, the proposed medicine's name, intended indication, and other relevant administrative information. It acts as a cover page and facilitates the efficient handling and tracking of the application.

The application form is to be used for an application for registration, variation, or renewal of a medicinal product for Human or Veterinary use submitted to the South African Health Products Regulatory Authority.

Applicants must submit a separate application form for each strength and pharmaceutical dosage form. Different strengths may however be submitted in one application form.


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