Table 5 Review of contravention of the law by three online pharmacies (see Table 6) identified during the study

Scheduled medicines/authorised persons: The websites were open to the public so any person can order scheduled medicine being offered (Scheduled 4 unregistered Biological injectable products are being offered)

Section 22A of Act 101 clearly states—“(…) no person shall sell, have in his or her possession or manufacture any medicine or Scheduled substance, except in accordance with the prescribed conditions.” Furthermore, Section 14 (5) stipulates who may possess or sell Scheduled medicines and under what conditions

Registration of medicines: Some of the Schedule 4 medicines (biological injectable) offered were not yet registered in South Africa, i.e. Xeomin; Bocouture; Azzalure; NeouroBloc etc.

Section 14 of Act 101 clearly states—“(…) no person shall sell any medicine which is subject to registration by virtue of a resolution published in terms of subsection (2) unless it is registered.”

Labelling requirements: Products advertised do not comply with local labelling requirements

Regulation 8 of Act 101 clearly stipulates how scheduled medicines sold in South Africa should be labelled. The website offers non-English labelled BOTOX (again Scheduled 4 Biological medicines are being offered direct to the Public)

Pharmacovigilance: No local South African contact person or site was provided on the websites. There was no indication on how adverse drug effect would be handled—an issue of public health safety

To satisfy the requirements of Regulation 37 on Adverse Drug Reactions

Pricing requirements: Products were offered and sold at higher prices than the approved Department of Health Single Exit Prices (SEP)

Section 22G of Act 101 clearly states the following under heading Pricing Committee 3(b)—“(…) no pharmacist or person licensed in terms of Section 22C (1)(a) or wholesaler or distributor shall sell a medicine at a price higher than the price contemplated in paragraph (a).”

Procurement requirements (warehousing/storage): some of the products were cold chain products—so it is unclear under what conditions these products are being shipped—a major quality concern

It is difficult to verify if GMP and GWP standards were maintained

Licensing of pharmacies: Some of the companies were not registered importers: e.g. Monarch Medical Supplies is not an authorised importer. All three websites were not registered with the SAPC

Section 22C of Act 101 clearly states the following on Licensing: “(…) no manufacturer, wholesaler or distributer referred to in subsection (1) (b) shall manufacture, import, export, act as a wholesaler of or distribute, as the case may be any medicine unless he or she is the holder of a license contemplated in the said.” subsection.” Regulation 12 of the Act states the conditions required to be able to import medicines (permits)