Tag Archives | 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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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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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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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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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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Our medicines regulatory authority: plans for reform in South Africa

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Posted 18 October 2012

By Andy Gray 

From the 3rd issue of the NSP Review  

One of the most important building blocks of any effective health system is a fully-functional medicines regulatory authority. In South Africa, this structure, established by an act of parliament, is entrusted with ensuring that the medicines made available in our country are safe, of good quality, and can be expected to have the effect for which they are indicated. 

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