Drug Registration In South Africa

What is a Drug?

A drug is any chemical substance that when consumed causes a change in an organism’s physiology, including its psychology, if applicable.

Drug Registration In South Africa

The product dossier compiled by the applicant company must be submitted to and approved by the MCC and is regarded as a legal contract.

The Certificate of Registration of a medicine confirms this and is the license to sell the medicine. Any amendment made by the company after registration must be approved by the MCC.

What are the requirements to import medication into South Africa?

This is stipulated in the Medicines and Related Substances Act (Act 101 of 1965 as amended).

South African legislation prescribes that only a South African registered company that is licensed by SAHPRA can import medicines registered by SAHPRA into South Africa.