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SA medicines regulator losing battle against illegal cannabis-products

South Africa’s medicines regulator is 'working closely' with the police to clamp down on illegal sales of unregistered cannabis-containing products claiming medical benefits, but has yet to successfully prosecute any companies or individuals breaking the law, according a senior official at the SA Health Products Regulatory Authority (Sahpra).

Business Day reports that it means businesses are continuing to cash-in on consumer demand for medical cannabis products, despite the regulator’s efforts to bring order to the sector. One of the most popular products is cannabidiol (CBD) oil, which proponents claim treats an array of medical conditions ranging from cancer to arthritis.

The Medicines and Related Substances Act says any products making medical claims must be registered with Sahpra as medicines. According to the report, Sahpra’s head of enforcement Griffith Molewa says none of the products currently on the market are registered, and the regulator has no applications pending. This means all the cannabis-containing products making medical claims currently on sale in South Africa are illegal, and consumers have no guarantee that they are safe and effective.

The penalty for selling unregistered medicines is a fine or a prison term of up to 10 years, he said.

The report says Sahpra is also trying to clarify the rules for products marketed as food supplements, and is collaborating with the health department to devise guidelines for the sector, he said.

At the other end of the supply chain, Sahpra has begun approving licences for the cultivation of medical cannabis, opening the way for local companies to gain a share of a rapidly growing international market. The report says the regulator has issued a statement saying it had written to three successful applicants, advising them of the conditions that would be attached to their five-year licences, but did not name the applicants.

Sahpra received 21 cultivation licence applications from March to December in 2018, and had continued to receive applications in 2019, said Molewa. Sahpra said in the report that none of the entities that had been granted cultivation licences had applied for licences to manufacture medicinal products containing cannabis, such as oil extracts.

Molewa said Sahpra had received applications for manufacturing medical cannabis products from other entities, but had yet to award any licences.

The report says while it is legal for doctors to prescribe cannabis-containing medicines in South Africa, the fact that no products have yet been registered by Sahpra means the only legal route for patients to access these products is by importing them under special provisions contained in section 21 of the Medicines Act.

A section 21 application has to be lodged by the prescribing doctor, and if approved, is valid for six months, according to Molewa. He said the application process had been streamlined, and could now be done online. It typically took less than a week to approve such applications, he is quoted in the report as saying.

[link url=""]Business Day report[/link]

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