Tag Archives | MCC

Medicines Control Council (MCC): guidelines on complementary medicines

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Posted 13 June 2016

A number of updated guidelines for complementary medicines have been published on the MCC web site:

7.01 Complementary Medicines – Discipline Specific Safety and Efficacy V3 13-Jun-2016  –
http://www.mccza.com/Publications/DownloadDoc/4411

7.03 Complementary Medicines – Use of the ZA-CTD format in the Preparation of a Registration Application V3 13-Jun-2016  –
http://www.mccza.com/Publications/DownloadDoc/4413

7.04 Complementary Medicines – Health supplements Safety and Efficacy V2 13-Jun-2016 –
http://www.mccza.com/Publications/DownloadDoc/4412

7.05 Complementary Medicines – Registration Application ZA-CTD – Quality V1 13-Jun-2016 –
http://www.mccza.com/Publications/DownloadDoc/4414

The definition of a complementary medicine, to include the category ‘Health Supplements’ as suggested in a previous draft,  is expected to be finalised soon. CAMs will in future be divided into discipline-specific CAMs (linked to the AHPCSA-regulated disciplines) and ‘Health Supplements’. Guidelines on safety and efficacy will be then separated for the two types of CAMs, but the quality guideline and ZA-CTD guidelines are common to both types.

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Crackdown looms on complementary medicinal products

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Posted 09 May 2016

This article by Tamar Kahn in Business Day Live, reports on the MCC claiming to be gearing up to seize “scores of illegal products claiming to treat diabetes, heart disease, cancer and viral illnesses”. The complementary medicines regulations, which were gazetted on November 15 2013, allowed firms to continue selling complementary medicines until they were called up for assessment by the council, starting with those deemed most risky. Only those that applied for registration as a CAM may continue to be sold until their submission has been assessed, and accepted or rejected. What is remarkable is how few complementary medicines have been submitted for registration.

The report quotes Mr Norman Fels, Chairperson of the Health Products Association (HPA), as stating that “the low response rate from the industry suggested companies were experiencing problems with the process, rather than ignoring the regulations”. However, several … Read the rest

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Reviv – vitamin intravenous (IV) drips – a wellness ‘Drip Bar’

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Posted 01 December 2015

REVIV, an international company which has opened its doors in Sandton, offers intravenous ‘treatment’ for a range of ‘conditions’. For example, “HYDROMAX rebalances your body with fluids fortified with electrolytes and antioxidants to maximize athletic performance”, “MEGABOOST restores your body with minerals, different anti-oxidants, electrolytes to bring your body back into equilibrium, maximizing your productivity, leaving you feeling healthy and refreshed”, “ULTRAVIV recovery infusion delivers anti-nausea medication, pain reliever, vitamin B-12 and an energy booster, this IV is best for those recovering from illness, hangovers or jet lag“. (underlining added) The infusion “ROYAL FLUSH” combines ULTRAVIV and MEGABOOST.

Is there any basis to these claims or is this pseudoscience at its worst? Even if the substances in these drips are 100% available in the blood, this does not necessarily mean that they will be more effectively used by the body than if … Read the rest

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Open season for snake oil salesmen?

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Posted 23 November 2015

This article written by patent attorney, Hans Muhlberg, is reproduced here with permission from the author.

Open season for snake oil salesmen?

Does the Advertising Standards Authority of South Africa  (ASA) have the jurisdiction to rule on adverts placed by companies that aren’t members of the ASA?

If you’re involved in ASA matters, you’ll know that it’s not uncommon for the ASA to rule on such ads. You’ll also know that these rulings tend to be effective, despite the fact that the ASA is a voluntary body, whose rulings are only binding on its members. The reason is simple –  the SA media companies (electronic, TV, print, billboard) belong to the ASA, which means that as soon as the ASA rules that an ad contravenes the ASA Code (by making unsubstantiated claims for example), the media companies refuse to touch the ad. So the ad’s … Read the rest

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D-day for complementary weight loss medicines?

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On 15 November 2013 the Minister of Health finally published Regulations to the Medicines Act (Medicines and Related Substances Act, 1965 (Act 101 of 1965), not for comment, but for implementation. They defined complementary medicines for the first time in South Africa. In addition the Regulations incrementally “called up” various complementary medicines over the following six years.

If a product that has been called up, and has not been registered, or an application for registration has not been received by the MCC, then according to the Medicines Act (Section 14(1)) it may no longer be sold.

The Regulations also created a new category of medicines – category D – which are complementary medicines “subdivided into such disciplines as may be determined by the Council after consultation with the Allied Health Professions Council of South Africa.”

This left “dietary supplements” out in the cold and the Health Products Association … Read the rest

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Complementary Medicines – Health Supplements Quality, Safety, Efficacy

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Posted 24 November 2014

The MCC has proposed an additional category, ‘health supplement’, to be included in the definition of a complementary medicine. This category requires to comply with parameters that were to be furnished in a guideline, that would define the requirements for the claims for efficacy, quality, safety, etc. This has now been formally released.  This document, released on the 20th November, is a draft released for comment by 26 February 2015.

“The purpose of this Guideline is to provide clear guidance with regard to the quality, safety and efficacy (QSE) requirements for registration of Health Supplements as a subset of complementary medicines in South Africa. The intent of this document is to ensure that the levels of evidence for QSE are rigorous enough to protect public health and maintain consumer confidence, while providing a clearly defined pathway to register health supplements.”

The document is available here.… Read the rest

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Complementary medicines regulations – an interpretation

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Posted 24 February 2014

René Doms is a registered pharmacist and also holds a law degree. He has been closely observing regulations pertaining to complementary medicine.

In this article, first posted to the email discussion group, DrugInfo, he shares his interpretation of the new regulations governing CAMS published in November 2013.

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Controlling quackery: will new regulations help?

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Posted 27 November 2013

An article (opinion) written by Kevin Charleston in relation to the new complementary medicine regulations recently published, has been published on the GroundUp website. The CAMS Regulations were published on the 15th November and can be downloaded from here or from the Government website. They need to be read in context with the document, Complementary medicines – Quality, safety, and efficacy, which can be downloaded here. It should be read in conjunction with those of Andy Gray and published here.

Kevin Charleston has written an excellent overview/opinion of the new CAM regulations and is best read on the GroundUp website, but we are posting the article below.

 

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Administrative Guideline: Complementary Medicines

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Posted 11 November 2013

The Medicines Control Council of the South African Department of Health has made available three documents as part of “Draft Administrative Guideline: Complementary Medicines – Quality, Safety, And Efficacy”.

Although the documents do not have a specific publication date, they are simply indicated as “November 2013”. Some indicate a very short comment period (22 November 2013).. 

Interestingly, one of the documents indicate that this is not “new” draft, but had been first published for comment as far back as August 2011.

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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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