South Africa's SAHPRA Issues Call-Up Notice for Complementary Medicine Regulation

• The Medicines and Related Substances Act, 1965, regulates medicines in South Africa.
• A 'call-up notice' can be issued to declare a category or class of medicine subject to registration.
• Homeopathic medicines are exempt from full registration but must still comply with Good Manufacturing Practice and labeling requirements.
• Complementary medicines that are not registered may still be subject to control according to their scheduling status.

The provision applied to homeopathic mother substances and so-called 'minute-dose forms' made in accordance with homeopathic principles.

The regulation of complementary and alternative medicines in South Africa has been a contentious issue for decades. In the 1960s, when the Medicines and Related Substances Act was first passed, many medicines on the local market had not been assessed for safety, efficacy, or quality. To address this, a stepwise approach was followed between 1967 and the mid-1980s, where medicines were identified for registration by pharmacological classification. This process is still evident in section 14(1) and (2) of the Act.

In 1986, an important exception was created that exempted homeopathic medicines from the full registration process. However, this exemption came with two key restrictions: no medical claims could be made for the medicine, and a specific warning label had to be included stating 'Use only as directed by a medical practitioner, pharmacist or homeopath'.

The scope of complementary medicines has since been broadened, with amendments to the legislation accommodating a wider range of traditional health professions. The South African Health Products Regulatory Authority (SAHPRA) now regulates Category D medicines, including co-medicines and homeopathic products.

The Medicines and Related Substances Act, 1965, sets out the framework for regulating medicines in South Africa. Section 14(1) and (2) of the Act provides that a 'call-up notice' can be issued to declare a category or class of medicine subject to registration. This notice can apply to both new and existing medicines, with those already marketed but exempted from full registration still subject to control according to their scheduling status.

Good Manufacturing Practice (GMP) is also crucial for the production of these medicines, regardless of whether they are registered or not. Manufacturers must provide evidence of a medicine's safety, efficacy, and quality to justify registration, although this exemption for homeopathic medicines has been in place since 1986.

While some complementary medicines may be exempt from full registration, they still require compliance with Good Manufacturing Practice and specific labeling requirements. This includes a warning to use only as directed by a medical practitioner or homeopath. Lawyers should be aware of these regulations when advising clients on the sale and marketing of complementary medicines in South Africa.

Lawyers should be aware that while some complementary medicines are exempt from full registration, they must still comply with Good Manufacturing Practice and include specific labeling requirements, including a warning to use only as directed by a medical practitioner or homeopath.

Source: Original reporting via Inside the Box With Dr Andy Gray