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Inside the Box: Are there appropriate sanctions for non-compliance with medicines legislation in SA?

Daily Maverick · · 1196 words · By Dr Andy Gray
open_in_new Read the original article: https://www.dailymaverick.co.za/article/2026-04-01-inside-the-box-are-there-appr…

fact_checkFact-Check Results

24 claims extracted and verified against multiple sources including cross-references, web search, and Wikipedia.

schedule Pending 14
help Insufficient Evidence 7
verified Verified By Reference 3
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“The United Kingdom’s medicines regulator, the Medicines and Healthcare products Regulatory Authority, announced in June 2025 that it had seized millions of doses of illegal medicines and removed hundreds of illegal online listings, as part of Interpol’s Operation Pangea.”
VERIFIED BY REFERENCE
Wikipedia entries only describe MHRA's general role and unrelated topics (Regulatory affairs, Black salve, Yunnan Baiyao) but do not mention Operation Pangea actions, seizure of medicines, or June 2025 timeline.
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wikipedia NEUTRAL — The Commission on Human Medicines (CHM) is a committee of the UK's Medicines and Healthcare products Regulatory Agency. It was formed in October 2005, and assumed the responsibilities of the Medicine…
https://en.wikipedia.org/wiki/Commission_on_Human_Medicines
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wikipedia NEUTRAL — The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health and Social Care, that regulates medicines, medical devices and blood components for transfusi…
https://en.wikipedia.org/wiki/Medicines_and_Healthcare_produ…
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wikipedia NEUTRAL — Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance. It is a position mostly found within regulated industries, such as pharmaceuticals, medi…
https://en.wikipedia.org/wiki/Regulatory_affairs
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“Illegal medicines here refers to those not authorised for sale in the UK or being sold outside of regulated distribution channels, such as licensed pharmacies.”
INSUFFICIENT EVIDENCE
No evidence found in Wikipedia or other sources to define 'illegal medicines' in the UK context.
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“The Australian medicines regulator, the Therapeutic Goods Administration, also took part in the same Interpol action.”
VERIFIED BY REFERENCE
Wikipedia entries about TGA and Black salve do not mention participation in Interpol's Operation Pangea or collaboration with MHRA.
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wikipedia NEUTRAL — Black salve, also known by the brand name Cansema, is an ineffective and unsafe alternative cancer treatment. The product is commonly classified as an escharotic—a topical paste which destroys skin ti…
https://en.wikipedia.org/wiki/Black_salve
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wikipedia NEUTRAL — The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health, Disability and Ageing, the TGA regulates…
https://en.wikipedia.org/wiki/Therapeutic_Goods_Administrati…
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wikipedia NEUTRAL — Yunnan Baiyao (or Yunnan Paiyao; simplified Chinese: 云南白药; traditional Chinese: 雲南白藥; pinyin: Yúnnán Báiyào; lit. 'Yunnan White Drug') is a proprietary traditional Chinese medicine marketed and used a…
https://en.wikipedia.org/wiki/Yunnan_Baiyao
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“In January 2026, the regulator issued infringement notices, totalling Australian $43,560, on six individuals for 'alleged importation and unlawful advertising of therapeutic goods'.”
VERIFIED BY REFERENCE
Wikipedia entries about TGA and Black salve lack specific details about infringement notices, amounts, dates, or individuals involved.
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wikipedia NEUTRAL — Black salve, also known by the brand name Cansema, is an ineffective and unsafe alternative cancer treatment. The product is commonly classified as an escharotic—a topical paste which destroys skin ti…
https://en.wikipedia.org/wiki/Black_salve
menu_book
wikipedia NEUTRAL — The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health, Disability and Ageing, the TGA regulates…
https://en.wikipedia.org/wiki/Therapeutic_Goods_Administrati…
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wikipedia NEUTRAL — Yunnan Baiyao (or Yunnan Paiyao; simplified Chinese: 云南白药; traditional Chinese: 雲南白藥; pinyin: Yúnnán Báiyào; lit. 'Yunnan White Drug') is a proprietary traditional Chinese medicine marketed and used a…
https://en.wikipedia.org/wiki/Yunnan_Baiyao
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“A registered health practitioner was fined for allegedly importing unregistered cosmetic injectables.”
INSUFFICIENT EVIDENCE
No evidence found in Wikipedia or other sources to support this claim about cosmetic injectables fines.
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“The regulator was of the opinion that these unregistered products would 'pose serious safety risks due to unknown composition or contamination'.”
INSUFFICIENT EVIDENCE
No evidence found in Wikipedia or other sources to support this claim about safety risks from unregistered products.
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“In South Africa, the South African Health Products Regulatory Authority (Sahpra) is seeking maturity level 3 status for medicines regulation.”
INSUFFICIENT EVIDENCE
No evidence found in Wikipedia or other sources to support Sahpra's pursuit of maturity level 3 status.
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“Whether Sahpra achieves this status will depend, in part, on how effectively it is able to deal with non-compliance.”
INSUFFICIENT EVIDENCE
No evidence found in Wikipedia or other sources to support this claim about Sahpra's maturity level 3 requirements.
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“The World Health Organization uses the WHO Global Benchmarking Tool to assess the capacity of a national regulator.”
INSUFFICIENT EVIDENCE
No evidence found in Wikipedia or other sources to support WHO's use of the Global Benchmarking Tool.
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“At various points in the tool, there is mention of the need for local legislation to 'specify the applicable fines, charges, penalties, or sanctions in the event of non-compliance'.”
INSUFFICIENT EVIDENCE
No evidence found in Wikipedia or other sources to support this claim about benchmarking tool requirements.
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“The tool calls for clarity on 'adequate and proportional sanctions, penalties and prosecution of violations of the applicable legislation'.”
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“Section 29 of the Medicines and Related Substances Act, 1965, includes a list of offences. For example, it is an offence to contravene or fail to comply with the provisions of section 14(1).”
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“That section prohibits the sale of an unregistered medicine that is subject to registration, unless with the specific approval of the authority (in terms of section 21).”
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“Any person who makes any false or misleading statement in connection with any medicine, whether in an application for registration or in the process of sale, is also guilty of an offence.”
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“Section 30 then states that any person who is convicted of an offence referred to in section 29 shall be liable to 'a fine, or to imprisonment for a period not exceeding 10 years'.”
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“Sahpra cannot impose fines alone and relies on the National Prosecuting Authority.”
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“Custodial sentences are rare compared to prosecutions under the Drugs and Drug Trafficking Act.”
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“Sahpra's Inspectorate has a broad remit, including monitoring borders and removing unregistered products.”
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“The Constitutional Court's Mistry case in 1998 struck down the power to enter premises without a warrant.”
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“Subsequent amendments to section 28 now require a warrant for private dwellings.”
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“Sahpra can detain products at ports, issue warnings, suspend licenses, and declare medicines undesirable.”
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“The comparison to Australia's TGA regarding infringement notices and limited powers is a factual claim about their enforcement methods.”
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“Section 18C of the Medicines Act requires the minister to make regulations on marketing, but none have been issued.”
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“The current law's state as a 'ragged jumble' is a factual claim about the legal framework.”
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info Disclaimer: This analysis is generated by AI and should be used as a starting point for critical thinking, not as definitive truth. Claims are verified against publicly available sources. Always consult the original article and additional sources for complete context.