Section 21 Archives

22 Mar Requests to use unregistered veterinary medicines under Section 21 of Act 101 of 1965

Posted at 13:47h in

This document provides guidance on access to unregistered medicines for animal use through the provisions of Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965). Applicants are required to comply with the provisions of the Act and Regulations....

22 Mar Section 21 Emergency Medicines Bulk Application Form

Posted at 13:43h in

Request For Use of An Unregistered Product In Terms of Section 21 of Act 101 of 1965...

01 Sep Veterinary Medicines Section 21 Application Form

Posted at 10:58h in

Request For Use of an Unregistered Product In Terms Of Section 21 Of Act 101 of 1965...

01 Sep Progress Report Form After Use of An Unregistered Product

Posted at 10:55h in

25 Jul Guideline on application for use of unregistered veterinary medicines

Posted at 13:23h in

This document guides access to unregistered medicines for animal use through the provisions of Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and clarifies the mandate, intent and scope of this section and Regulation 29 of the General Regulations...

01 Feb Section 21 Authorisation of Sale Unregistered Medical Devices

Posted at 11:08h in

2017 Nov...

25 Jan Guideline For Section 21 Access To Unregistered Medicines

Posted at 13:20h in

This document provides guidance on access to unregistered medicine for human use through the provisions of section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), and clarifies the mandate, intent and scope of this section and regulation 29 of the...

25 Jan Section 21 Access to Unregistered Medicines – IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME

Posted at 13:18h in

Given that there is currently no credible evidence to support a therapeutic role for Ivermectin in COVID-19, SAHPRA has decided to terminate the Programme with immediate effect.

Date uploaded

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25 Jan Availability of medicines for use in a Public Health Emergency (PHE)

Posted at 10:24h in

This guideline provides recommendations to applicants who intend to submit applications for the registration or authorisation of medicines intended to be available to those affected by a public health emergency. It represents the current thinking of the South African Health Products Regulatory Authority (the Authority)...

30 Aug Complementary Medicines Section 21 Application Form

Posted at 15:09h in

In terms of this Section, the Authority may authorize the sale of unregistered orthodox medicine, complementary medicine, and veterinary medicine or device for certain purposes....

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