• Version
• Download 24
• File Size 913.81 KB
• File Count 1
• Create Date April 4, 2025
• Last Updated April 4, 2025

Guideline on Evaluation And Authorisation of Unregistered Health Products and Technologies

This Guideline is intended to clarify the mandate, intent and scope of access to unregistered medicines for human use through the provisions of Rule 16 of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022, and clarifies the mandate, intent and scope of this Rule published in terms of the Act (CAP 244). It outlines the process to be followed when requesting an unregistered health product, as well as the information required to comply with the provisions of CAP 244 and the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022.

Attached Files