Author Archives: mraregulatory

Cosmetics in South Africa

When it comes to cosmetics every person has their preferences and different reasons for using the products and brands that that they use. This could be based on the ingredients, what the brand represents, the reactions it has on their skin or their policy on animal testing. However, South Africa has its own regulations when it comes to the cosmetics that it sells. Every country has its own regulations that they enforce with cosmetic companies. This includes the labelling, advertising and the actual contents of the products.

Cosmetic Labelling
There are laws in place in South Africa that enforce certain behaviours in cosmetic brands. These laws and requirements are in place for the benefits of the consumer. This is to ensure that there is brand and product transparency. A few of the things cosmetic brands need to comply with is that the labelling must include: the brand name, the product name, it must be in English, a list of ingredients, the labelling must not be misleading, the products with healing or medical claims needs to be registered at the Medical Control Council (MCC), and the products with slimming or muscle enhancement claims needs to be registered at the MCC.

Cosmetic Ingredients
There are some ingredients that are not allowed to be used in cosmetics that are sold in South Africa. These have been banned for health and safety reasons. The unfortunate reality is that some of these ingredients are still being used, and there have been recent problems with people using skin lightening creams and cosmetics that contained illegal ingredients such as: hydroquinone, steroids and mercury. These ingredients are harmful to the people who use them and they cause irreversible damage to the skin and the body.

MRA Regulatory Consultants
The winds of change are upon the cosmetics industry in South Africa, and it is highly imperative that all companies comply with the new rules and regulations that are coming into place and that will be brought into place. For great cosmetic regulatory consultation and evaluations, contact MRA Regulatory Consultants!

The Homeopathic Medication in South Africa Homeopathic medication and health supplements are not a new term to many people, it is the natural medications that people make and choose to use instead of conventional pharmaceuticals. There are many reasons that people choose to use homeopathic medication, such as their overall health, the fact that it… Continue Reading

The Different Classes of Medicines in the Pharmaceutical Industry Medicine has become a crucial part of contemporary life, and it comes in varying forms. Without advancements in science in this field life would be far shorter, and its quality far lower than we know it to be today. Vaccinations, treatments, supplements and cosmetic products have… Continue Reading

Different Forms of Complimentary Medicines and Treatments Complimentary medicines have become a fairly accepted part of the healthcare field, and while there is somewhat of a divide in people who believe in them and those who don’t, many of them do actually come with evidence of success and effectiveness. Because so many people rely on… Continue Reading

Phrases you Won’t See on a Label Anymore The food, consumables and many other industries have the responsibility of ensuring that their consumers are properly informed before making any purchases; which is why labels have become a standard on all retail products. And while they are generally well governed according to the Consumer Protection Act… Continue Reading

Guidelines for Labelling Regulations in South Africa Labelling and packaging on commercial goods serves a far more important function than simply attracting consumers. It provides them with information that allows them to make an informed decision about their purchases. This is because labels are expected to contain information on nutritional information (in the case of… Continue Reading

Templates for Authoring Regulatory Documents in Africa   MRA has created CTD document templates and their links to guidance documents to assist you in writing your regulatory documents. These templates will ensure consistency in presentation of documents and support the author in finding the relevant current guidance documents to consider and refer to when writing… Continue Reading

Other News 24 February 2017 Call-in for all businesses involved in the sale and distribution of Medical Devices and IVDs to license within a certain period: Manufacturers and Distributors – within 6 months Wholesalers – within 12 months Call-up Notice R 204, Gazette 23128 of 22.02.2002 rescinded. This call-up addressed the submission of abbreviated regulatory information… Continue Reading

eCTD News The eCTD has gone live as a submission format for all new applications for registration. The Implementation Guidance of the South African eCTD specification v2.1 and the related Validation Criteria v2.0 was published on the MCC website and updated in November 2016. Continue Reading

Changes to Regulations to the Medicines and Related Substances Act Draft General Medicine Regulations were published for comment on 27 January 2017. The comment period (3 months) closes on 26 April 2017. Follow the link to view the regulations: 2017-01-27_GG40577_MedicinesAct_Draft_GeneralMedicineRregulations Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs) were published on 9… Continue Reading

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