The sale of unregistered medicine has become a talking point in South Africa and globally with the advent of SARS-CoV-2. Jargon such as “compassionate use”, “public health emergency”, “section 21” and “compounding” has come to the fore.
BUT, MAY UNREGISTERED MEDICINE BE SOLD IN SOUTH AFRICA?
Complementary medicines come to mind immediately, since these are sold unregistered currently. However, complementary medicines will be called up for registration in the future.
WHAT ABOUT MEDICINES WHICH HAVE ALREADY BEEN CALLED UP FOR REGISTRATION?
The Medicines Act provides legal mechanisms allowing access to unregistered medicines which are subject to registration:
- Section 21 of the Medicines Act allows SAHPRA to provide written authorisation to any person to sell a certain quantity of an unregistered medicine for a specified period to a specific person or institution. An example of the application of this mechanism is the access to unregistered COVID-19 vaccines as well as Ivermectin-containing medicine.
- Ivermectin-containing medicine also became available under section 14(4) which provides that registration requirements shall not apply in respect of the sale of any medicine compounded, with conditions.
- Furthermore, section 36 may be employed to exclude, subject to conditions, any medicine from the operation of any or all of the provisions of the Medicines Act, including registration provisions. An example of the application of this provision was the exemption of CBD from its scheduling status and the right of sale, without registration of CBD-containing medicines, which followed.
- Lastly, provision is also made for permission to use unregistered medicines for analytical, scientific and other purposes, on certain conditions.
MAY UNREGISTERED MEDICINES BE SOLD IN SOUTH AFRICA?
Yes, but care has to be taken to utilise the correct mechanisms and also to abide to the accompanying conditions.
I hope you have found this letter informative. Please let me know should you need further assistance in this regard.
