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Understand Section 21 Regulations

Navigating Section 21

Your Guiding Partner Through Regulatory Compliance

MC Pharma can assist with import and supply of unregistered orthodox medicine or veterinary medicine into South Africa on a Section 21 basis.

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Section 21 Regulations

An Overview

The main purpose of any authorisation granted by SAHRPA in terms of section 21 of the Act is to provide access to medicines on an exceptional basis, where conventional therapies have been ruled out, have failed or are unavailable.

Section 21 Safety

Efficacy and Quality

This must always have regard to the safety, efficacy and quality of medicines accessed through section 21 which are set out in regulation 29. Affordability on its own is not generally a significant reason to grant a section 21 authorisation, however, applications will be considered by SAHPRA on a case-by-case basis.

Expertise Tailored to Your Needs

Seamless Navigation Through Regulatory Hurdles

Leverage MC Pharma’s seasoned expertise in navigating Section 21 compliance.

FAQ's

Clarifying Your Regulatory Queries

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