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Wednesday, November 23, 2022

EXPLAINER | Sisulu meds comments: What does the law say about importing medicines?

Must read

  • The SA Well being Merchandise Regulatory Authority is partaking with Tourism Minister Lindiwe Sisulu after stories that she introduced drugs from Russia for ANC deputy secretary-general Jessie Duarte.
  • Duarte died on Sunday after a battle with most cancers.
  • News24 appeared on the legal guidelines in place to regulate the importation of medication.

The SA Well being Merchandise Regulatory Authority (Saphra) has approached the workplace of Tourism Minister Lindiwe Sisulu for clarification after she reportedly mentioned on Sunday that she introduced remedy from Russia for ANC battle stalwart Jessie Duarte.

Duarte died of most cancers earlier that day.

TimesLIVE reported that Sisulu was talking at Duarte’s residence in Observatory, Johannesburg on the time and that she mentioned she arrived with the remedy in South Africa too late.

However when she spoke to the Weekend Argus, she mentioned the media had misinterpreted her feedback exterior of Duarte’s residence and the medication was all “in my head”.

“The drugs is in my head, not in my pocket.”

News24 appeared on the guidelines in place to regulate the import and export of medicines.

What does the legislation say about bringing drugs into the nation?

In a press release on Wednesday, Sahpra CEO Boitumelo Semete mentioned it famous the quite a few media articles on the matter and that it was subsequently partaking with the minister.

Semete indicated there have been strict guidelines for the import and export of medicines and that solely a South Africa-registered firm that was licensed by Sahpra may import medicines.

Semete added that Sahpra had a mechanism in place that authorises entry to particular portions of a product for a selected affected person if a treating oncologist must safe an unregistered drugs for a affected person.

Werksmans Attorneys’ head of healthcare and life sciences, Neil Kirby, instructed News24 that whereas the circumstances round Sisulu’s feedback have been unclear, the import of medicines was strictly managed by way of the rules promulgated underneath the Medicines and Associated Substances Act, 1965.

“Extra notably, Regulation 6, which requires that an individual importing medicines or scheduled substances will need to have a licence to take action,” Kirby added.

He mentioned:

An individual could, nonetheless, import medicines or scheduled substances for his or her private use by way of Regulation 8, however solely underneath sure situations.

The situations embody Schedule 3, 4, or 5 substances the place the amount doesn’t exceed the amount required to be used over six months, or Schedule 6 substances the place the amount doesn’t exceed the required use for a interval of 30 days.

Schedule 3 to six medicine are medicine which are solely out there on prescription.

Kirby mentioned a person needed to be in possession of the unique prescription for such a substance, an authorized copy of the prescription or a certificates or letter issued by the one that prescribed and distributed the substance.

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