Archive | SAHPRA

Health supplements, complementary medicines will soon no longer be regulated

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Posted 29 October 2020

The headline of this IOL piece is somewhat misleading.

By Zelda Venter

IOL

Pretoria – Health supplements and complementary medicines – which are not scheduled medicines as defined by the Medicine’s Act – will soon no longer be regulated by the South African Health Products Regulatory Authority, which regulates all medicines, including scheduled medicines.

But, while the Gauteng High Court, Pretoria, did strike down the current regulations over these substances, it made it clear that alternative medicines still had to be regulated.

Judge Elizabeth Kubushi gave the minister of health and the regulatory authority 12 months to determine how best to regulate these alternative medicines.

“I am loath to leave the regulation of complementary medicines without a time frame.”

She said 12 months should give the health authorities ample time to decide how best to regulate this popular industry.

The order was sparked by the Alliance Read the rest

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Regulation 11 should prevent promotion of quack Covid-19 treatments, but does it?

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Posted 14 April 2020

By Tendai Mafuma• 31 March 2020

Daily Maverick

Tendai Mafuma describes what happened when SECTION27 tried to use new regulations to bring an end to the promotion of an unproven treatment for Covid-19 in South Africa and compares the current situation with the TAC’s successful court battle against Matthias Rath’s promotion of unproven Aids treatments.

The worldwide spread of the Covid-19 virus has led to widespread anxiety and panic. There are many factors causing this anxiety and panic with the absence of a vaccine or cure among the biggest factors.

South Africa’s public health system (that supports 84% of the population), is already buckling under the high prevalence of HIV/Aids and TB. Further, some life-saving medicines are often priced beyond the reach of many. It therefore comes as no surprise that everyone would be on edge and will desperately be on the lookout for affordable medicines Read the rest

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Warning: SAPS warns that dealing in cannabis is still illegal For immediate release

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Posted 07 November 2019

SAHPRA MEDIA RELEASE

Warning: SAPS warns that dealing in cannabis is still illegal For immediate release

Joint media statement issued by the South African Police Service and the South African Health Products Regulatory Authority (SAHPRA)

Pretoria: 4 November 2019 – The South African Police Service is issuing a stern warning that the establishment of illegal dispensaries/outlets, online sites and social media platforms which are marketing and selling cannabis and cannabis-related products to the public remains illegal, except where specifically allowed in terms of the Medicines and Related Substances Act.

Some of these illegal businesses, purporting to be operating legally in terms of the Traditional Health Practitioners Act (No. 22 of 2007), are also being sold to members of the public as franchises authorised to deal in cannabis and cannabis-related products. In terms of the Traditional Health Practitioners Act, the definition of “traditional medicine” means an object Read the rest

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Status of cannabis-containing products (including oils) and the cultivation of cannabis for medicinal use

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Posted 06 February 2019

This communication to stakeholders has been placed on the SAHPRA web site and should provide much-needed clarity on the legal status of the many cannabis-containing products that are currently on the South African market, but also on the use of the section 21 process for access to quality-assured medicinal products.

Status of cannabis-containing products (including oils) and the cultivation of cannabis for medicinal use

https://www.sahpra.org.za/Publications/DownloadDoc/7655

1 INTRODUCTION

On the 18th September 2018 the Constitutional Court handed down a judgment1, which declared existing legislation, criminalising the use, possession, and cultivation of cannabis, unconstitutional. It would, therefore, now not be an offence for an adult person to:

  1. use or be in possession of cannabis in private for his or her personal consumption in private; and b. to cultivate cannabis in a private place for his or her personal consumption in private.

The Court also found section 22A(9)(a)(i) of Read the rest

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Update on Current Operations at SAHPRA’s Interim Premises

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Posted 05 February 2019

To all SAHPRA Stakeholders

Further to our communication of 25 January 2019, this notice serves to provide clarity on current operations at SAHPRA’s interim premises (CSIR), following the recent emergency relocation. As with any physical relocation, it is taking time for SAHPRA’s infrastructure, systems and processes (including internet and remote access to the National Department of Health network) to be re-established. The cellphone contact numbers under Key Contacts on the website should be used. More details with regard to contact information and new landline phone numbers will be communicated shortly.

Whilst Reception in Building 38a will open on Friday 1 February 2019, all stakeholders are advised to please adhere to the following guidelines.

Medicines registrations and variations

As previously advised, SAHPRA is embarking on an ambitious change program to clear its inherited backlog of medicines registration and variation applications. This program involves designing and implementing new Read the rest

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Prof Roy Jobson, who fought against quackery, dies at 63

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Posted 23 January 2019

Roy Jobson was my friend, my colleague, my sounding board, and a tower in the fight against pseudoscience, quackery and scams. I often asked him to check the reasoning and facts of my posts to CamCheck and he contributed a number of articles himself. His death is a loss to South Africa, the medical community, and in particular to his family. I have lost a true comrade, and ‘brother’. Dr Harris Steinman (Editor, CamCheck)

Prof Helen Rees, the Chairperson of SAHPRA (South African Health Products Regulatory Agency), had this to say:

On behalf of SAHPRA,  I would like to echo the sadness that has been expressed by so many colleagues at the passing of Roy Jobson who was a truly unique man. His passion for medicines and for public health was underpinned by his belief in equity and honesty. He made a great contribution to medicines Read the rest

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Marketing Code Authority (MCA) Code of Marketing for Health products

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Posted 21 January 2019

With respect to the advertising and promotion of health products in South Africa, the Marketing Code Authority (MCA) Code of Marketing for Health products is very specific with respect to such “natural” claims. These requirements were implemented with the 2018 Code update:

“5.7.4.6         Natural Ingredients

5.7.4.6.1        ‘Natural’ used in the context of ‘Natural Ingredient’  means essentially ingredients provided by nature, not the work of man or interfered with by man.

5.7.4.6.2        It shall be misleading to use the term ‘natural’ to describe ingredients that employ chemicals to change their composition or comprise the products of new technologies, including additives and flavourings that are the product of the chemical industry or extracted by chemical processes.

5.7.4.6.3        Advertising and/or promotional material shall not suggest that the safety, quality or efficacy of a Health Product is due to the fact that it is natural.

5.7.4.6.4        Advertising and/or 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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