New regulatory regime for medicines comes into force in SA
Ronald Gibson (15 June 2017):
And there you have it, for the notice of all the people in South Africa that many of us had warned since 2013, but took no notice. This includes those in the cosmetic trade, as well as home and cottage industry making affected hand made products, that thought I was crazy to say that they would sneak them in at the last minute. This is what happens when everybody sticks their heads in the sand, unwilling to support those that fight for their rights, sign a petition or write a measly letter to the minister of health.
By December of this year, every product that falls under the definition of this corrupt Amendment and that has not applied for registration, may NOT be sold in South Africa, period. Not in shops, via private sale or on the internet. I assume that this cancels the call-up period that was supposed to end in 2019.
This effectively takes away your right to self determination of your health and cosmetic choices. It also means that by December this year, tens of thousands of people will lose their jobs and businesses as they cannot afford the utterly ridiculous costs associated with registration with an institution whose staff circulates the following article to pharmacists in the country, encouraging them participate as in Australia to set up a whistle blower system in order to report on each other if they should dare sell an unregistered CAMs product: "WHY DO PHARMACIES SELL CMS?"https://ajp.com.au/columns/opinion/pharmacies-sell-cms/.
You will now be totally at the mercy of pharmaceutical companies like Aspen and their ever willing, open handed prostitutes. But then again, that seems to have been your default, do-nothing choice.
The definition of "medicine" has been amended to read as follows:
"(a) Means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in -
i. The diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in humans; or
ii. Restoring, correcting or modifying any somatic or psychic or organic function in humans; and
(b) Includes any veterinary medicine."
Please take note of the little sentence stating "Powers vested in SAHPRA include those to register products as one or more of a medicine, medical device, COMPLEMENTARY MEDICINE, FOODSTUFF, COSMETIC or in vitro diagnostic medical device. To this end, amendments have been effected to section 14 of the Medicines Act, WHICH REQUIRE THAT ONLY REGISTERED PRODUCTS ARE ALLOWED TO BE SOLD in South Africa.
With effect from June 1 2017, the Medicines and Related Substances Amendment Act, No 72 of 2008, came into force by proclamation by the President of the Republic of South Africa.
The coming into force of the Amendment Act is significant insofar as it shifts and fundamentally changes the medicines regulatory regime in South Africa, and alters the Medicines and Related Substances Act, No 101 of 1965, as amended (the Medicines Act).
The Amendment Act of 2008 must be read together with a further Amendment Act, being the Medicines and Related Substances Amendment Act, No 14 of 2015. Both Amendment Acts come into force simultaneously and give effect to numerous amendments to the Me-dicines Act."