Counterfeit Medicines: Proposed Amendments of the General Regulations of the Medicines Act
The General Regulations currently defines a counterfeit medicine as a medicine in respect of which a false representation has been made about its contents, identity or source by any means including its labelling and packaging. The proposed definition for falsified medicine describes it as a medicine for which the identity, composition, or source is deliberately […]
What is the difference between registration and licensing?
Quite a lot. The words “registration” and “licensing” used in the Medicines Act and its regulations have different meanings and cannot be used interchangeably. Registration pertains to medicines, medical devices and IVDs. In general, the sale of these products is prohibited if they are subject to registration and are not registered. On successful application for […]
Complimentary MedicinesCategories, sub-categories & legal implications
Medicines are categorized in accordance with the General Regulations made in terms of the Medicines Act. Categories of medicines are designated as A, B, C and D. Category A medicines are conventional medicines intended for human use and category C medicines are conventional medicines for animal use, both without further manipulation. Category D medicines are complementary medicines […]
Pharmacodynamic and Pharmacokinetic Synergism
Synergy has become a popular word indicating that a whole entity is worth more than the sum of its parts. Investment bankers refer to synergy when company mergers result in a new company of a greater value than the sum of the values of the individual companies. A synergistic relationship occurs when two people create […]
The status of Complementary Medicines
This opinion was written in order to clarify the current status of complementary medicines. The matter of the Alliance of Natural Health Products (South Africa) v The Minister of Health and Another (case number 11203/2018) (ANHP case) and the following appeal by the Minister of Health and Another v Alliance of Natural Health Products (South […]
Pharmalaw Newsletter Jan – Feb ’22
Another year has started following the eventful 2020 and 2021. Some of us may look back on these years with anxiety and sadness. But 2022 has arrived and it is a New Year bringing with it new ideas, new opportunities, a new way of living and hopefully some travelling locally and abroad. In the pharmaceutical […]
May unregistered medicines be sold in South Africa?
The sale of unregistered medicine has become a talking point in South Africa and globally with the advent of SARS-CoV-2. Jargon such as “compassionate use”, “public health emergency”, “section 21” and “compounding” has come to the fore. BUT, MAY UNREGISTERED MEDICINE BE SOLD IN SOUTH AFRICA? Complementary medicines come to mind immediately, since these are […]