Archive | MCC (Medicines Control Council)

SAHPRA warns the public about consuming illicit sexual enhancement drugs

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Posted 23 September 2019

Warning – Illicit and dangerous erectile dysfunction medicines

Pretoria, 28 June 2019 – The South African Health Products Regulatory Authority (SAHPRA) warns consumers not to buy illicit and dangerous medicines containing sildenafil, a substance used in the treatment of erectile dysfunction. Medicines such as Viagra, Dynafll and Avigra are approved by SAHPRA and must be prescribed by a doctor.

Any person who wishes to acquire these products needs diagnosis, prescription, management and close monitoring by authorised medical professional/s. Viagra contains sildenafil, which is a substance listed in Schedule 4 of the Medicines Schedules, as treatment for erectile dysfunction. Substances listed in this schedule require registration with SAHPRA together with the licensing of the facility that either manufactures, distributes or sells these.

Most of the illegal products are imported into the country illegally. There are few manufacturing facilities in the country, like the one that was recently Read the rest

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12 questions answered on the state of SAHPRA

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Posted 13 December 2018

In February 2018 the Medicines Control Council (MCC) was replaced by the South African Health Products Regulatory Authority (SAHPRA). Spotlight sent SAHPRA a list of 12 questions to gauge how things are going with the new regulator, particularly regarding the backlog of medicines to be registered.

https://www.spotlightnsp.co.za/2018/12/05/12-questions-answered-on-the-state-of-sahpra/

The below responses were sent to us by SAHPRA Acting CEO Portia Nkambule on behalf of the SAHPRA board chairperson Professor Helen Rees. We quote these responses in full so as not to lose any of the rich and valuable detail.

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Medicine Act: General Regulation 42 – 18 C Marketing of medicines

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Posted 04 May 2018

Section 18C of the Medicines Act has been amended to read as follows:

“18C. Marketing of medicines, medical devices or IVDs.-The Minister shall, after consultation with the relevant industries and other stakeholders, make regulations relating to the marketing of medicines, medical devices or IVDs and such regulations shall also provide for Codes of Practice for relevant industries.”

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Regulating the South African sport supplement industry: ‘Whey’ overdue

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Posted 19 March 2018

This article by K Naidoo, R Naidoo, and V Bangalee from the Discipline of Pharmaceutical Sciences, School of Health Sciences, Westville Campus, University of KwaZulu-Natal, Durban, and Discipline of Biokinetics, Exercise and Leisure Sciences, published in the South African Medical Journal, addresses the sorely needed regulation of the sports supplements industry.

Many sport supplements currently on the market are likely to be little more than placebos, containing either grossly under-dosed products or ingredients with no proven benefit. In a largely unregulated industry, consumers who complement their diet with supposedly safe and effective supplements, may be doing so to their own detriment, particularly when these are used in high doses or without medical supervision.

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Wondernut (Indian Walnut) – Toxic weight-loss product

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Posted 03 October 2017

This press-release today from the Medicines Control Council, warns that a weight-loss product containing Indian Walnut, it toxic and can harm consumers.

The product is sold at www.wondernut.co.za and www.wondernutjoburg.co.za

Most of our postings are about Wondernut. However, the same nut is being sold on other websites and Facebook under different names: Zemiente (zemiente.com); Nuez de la India (nuezdelaindia.co.za); Indian Walnuts (indianwalnutsa.co.za); Leynate (indianwalnutsa.co.za); Magic Nut (magicnut.co.za); and others.

I have searched everywhere for credible evidence that this product will result in weight-loss. I cannot find a single source to confirm the claims, even in traditional sources.  Natural Medicines Comprehensive Database (“Unbiased, Scientific Clinical Information on Complementary, Alternative, and Integrative Therapies”) does not mention its use for weight loss, but “is used [traditionally] for asthma, bloody diarrhea, dysentery, sprue, and as a bowel stimulant“. For safety, it states, among other: “. . . seeds Read the rest

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Finalised Medicines Regulations have been published

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Posted 28 August 2017

The Finalised Medicines Regulations have been published at last: http://www.gov.za/sites/www.gov.za/files/41064_gon859.pdf

Regulation 42(5)(c)(ii)(cc) requires that advertisements for unregistered complementary medicines include the disclaimer: “This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use.”

It also includes regulations governing Complementary medicines, and “Health Supplements

“complementary medicine” means any substance or mixture of substances that –

(a) originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substance as determined by the Authority;

(b) is used or purporting to be suitable for use or manufactured or sold for use –

(i) in maintaining, complementing or assisting the physical or mental state; or

(ii) to diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or the symptoms or signs thereof or abnormal physical or

mental state of a human being or animal; and is used-

  • as a health
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Complementary medicines: When regulation results in revolution

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Posted 30 May 2017

This article, published in the South African Medical Journal (SAMJ), is in related to the recent publication of regulations and drafts that will regulate so-called ‘complementary medicines (CAMS). The authors point out that “[T]he majority of complementary medicines that were on the market before the General Regulations came into effect, are now under threat and the nature of the industry will change once the new laws are fully implemented”. The important point is made that the Amendments do not change the process of regulation of complementary medicines.

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Complementary Medicines – 2 more guidelines published for comment

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Posted 21 April 2017

Two more complementary medicines/health supplements guidelines have been published for comment by the MCC:

The deadline for comment is 31 May 2017.

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Medicine: Section 29: Offences

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Posted 14 March 2017

  • Section 29: Offences
    • Violation of s14
  • Making false or misleading statement in connection with any medicine or Scheduled substance in registration application or in sale
  • Container has false or misleading statement
  • Selling is defined broadly
  • Distributing and promoting are included
    • Violation of s20
  • False or misleading advert or making additional unauthorised claims re.  efficacy or purpose
  • Section 30: Penalties
    • Fine; or
    • Imprisonment for a period not exceeding 10 years
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Cultivation of Cannabis and Manufacture of Cannabis-related Pharmaceutical Products for Medicinal and Research Purposes

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Posted 07 March 2017

The MCC has published a draft guideline for comment entitled “Cultivation of Cannabis and Manufacture of Cannabis-related Pharmaceutical Products for Medicinal and Research Purposes”, accessible at http://www.mccza.com/Publications/DownloadDoc/5500.

The closing date for comment is 30 March 2017.

This is an extensive document, arranged as follows:

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