Tag Archives | MCC

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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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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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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The 2002 “call-up notice” for complementary medicines rescinded

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Posted 27 February 2017

GOVERNMENT NOTICE: DEPARTMENT OF HEALTH

No. 157

24 February 2017

MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965)

The Medicines Control Council by virtue of the powers vested in it by section 14(2) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), has by resolution approved by the Minister of Health, resolved to rescind the call -up notice for medicines frequently referred to as complementary medicines as published in the Government Notice R.204, Gazette No 23128 of 22 February 2002.

DR JC GOUWS

REGISTRAR OF MEDICINES

http://www.gov.za/sites/www.gov.za/files/40637_gon157.pdf

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MCC: Two new sets of regulations

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Posted 31 January 2017

The Minister of Health has published two sets of regulations on 27 January 2017

  1. General Regulations to the Medicines and Related Substances Act (GoN 50, GG. 40577, 27 January 2017), for comment by 27 February 20167 according to the gov.za web site, but within 3 months according to the text – http://www.gov.za/sites/www.gov.za/files/40577_gon50.pdf

This is a comprehensive set of proposed regulations to accompany the launch of SAHPRA and allow for the promulgation of the 2008 and 2015 Amendment Acts. The ToC is as follows (and includes 25A. Sub -categories of complementary medicines):

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South African Medical Device and IVD regulations

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Posted 21 December 2016

The medical device and IVD regulations have been published as Government Notice No. 1515 in Government Gazette No. 40480, dated 9 December 2016, and are accessible at http://www.gov.za/sites/www.gov.za/files/40480_gon1515.pdf

(also available on CamCheck as a pdf, and converted to text)

The Sepedi version is at http://www.gov.za/sites/www.gov.za/files/40480_gon1515_pedi.pdf

These are final regulations, for implementation and the ToC is as below:

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South African Medical Device and IVD regulations

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Converted but not checked for errors 

DEPARTMENT OF HEALTH NO. 1515         09 DECEMBER 2016

MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT NO. 101 OF 1965)

REGULATIONS RELATING TO MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVDs)

I, Dr A Motsoaledi, the Minister of Health has, in consultation with the Medicines Control Council, in terms of section 35(1)(xxvii) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), made the regulations in the Schedule.

SCHEDULE LIST OF CONTENTS

1.      Definitions

2.     Manner and conditions for allowing international tendering

3.     Importation of medical devices and IVDs into the Republic

4.     Transmission of medical devices or IVDs through the Republic

5.     Licence to manufacture, import, export, or act as a distributor or wholesaler of medical devices or IVDs

6.     Period of validity of licence issued in terms of regulation 5 and renewal of licences

7.     Appeal against the decision Read the rest

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Court affirms Medicines Control Council’s powers

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Posted 13 December 2016

Court affirms Medicines Control Council’s powers

Judgement is a victory for the scientific governance of medicine

By and

Acting Judge Vuyani Ngalwana delivered an important judgment in the Gauteng High Court on 6 December. Although the case is technical and superficially obscure, the judgment has important positive consequences for our health.

Since the scandal surrounding the fake AIDS medicine Virodene in the 1990s, there has been controversy about how we legislate the use of medicines. Simply put, on the one side of the controversy are the supporters of what is called the scientific governance of medicine, the principle that the state, through the Medicines Control Council (MCC), should regulate medical claims about products based on the best available evidence. On the other side are companies that make untested or plain false health claims about the products they

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