Medicines Application Form Module 1.2.1

Medicines Application Form Module 1.2.1

This application form should be included in the South African Common Technical Document – Module 1 Administrative Information.

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.

A separate application form for each strength and pharmaceutical dosage form is required.  However, different strengths may be submitted in one dossier.

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Document Number: GLF-BAU-HPA-07A
Version: 7
Date Updated: 18/05/2023
File Type: docx
Category: Application forms, Form
Unit: General ECTD & human medicines