Pharmaceutical & Cosmetic Review

Legal

12 Aug 2020

New cannabis rules announced

The legal classification of cannabis, or THC, has shifted significantly. Werksmans Attorneys takes a closer look at the amendments to the Medicines Act published on 22 May 2020. Cannabidiol is a Schedule 4 substance. However, cannabidiol is a Schedule 0 substance when the following criteria are met: It’s contained a complementary medicine as that term...
10 Mar 2020

How to mitigate the risk of nitrosamine formation during medicine manufacturing

The European Medicines Agency (EMA) have recently released a publication instructing Marketing Authorisation Holders (MAH) to take precautionary measures to mitigate the risk of nitrosamine formation or presences during manufacture of all medicines containing chemically synthesised active substances.  Nitrosamine impurities have been in the regulatory spotlight since they were discovered in several blood pressure medicines...
10 Dec 2019

The key objectives of the new EU medical device regulations

The past number years have seen a significant improvement in medical device sciences and technologies that have transformed the industry for the better of the patient. A medical device is a healthcare product or piece of equipment a person uses for a medical purpose. Medical devices play a crucial role in improving the lives of...
15 Nov 2017

Revised standards to improve medicinal product description

A series of Identification of Medicinal Products (IDMP) standards are under revision and will bring a host of benefits to patients and the global health care community.

07 Nov 2016

Innovation and compliance converge on UL’s Prospector

It is crucial for formulators to remain abreast of global regulatory changes. The latest developments on Prospector, the materials and ingredients search engine from UL, provide the personal care industry with an overview of global regulatory information.

24 Aug 2016

Setting the quality standards

A quality system is crucial in the manufacturing of cosmetics to maximise product quality outcomes and maintain compliance, be it with local or international regulations. The essence of this is outlined in a white paper by John Garvey, CEO of Compliance Architects.

20 Jul 2016

Understanding the EU Cosmetics Regulation and attaining compliance

It has been almost three years since the EU Cosmetics Regulation was put in force across Europe, replacing the preceding EU Cosmetics Directive. It is evident that it has become a real challenge for the cosmetics industry - even global brand leaders - to meet the robust regulatory requirements of the regulations. Even now, we are witnessing many providers of cosmetics products supplying products that do not fulfil all of the robust regulatory requirements of the cosmetic regulation.

28 Feb 2016

Rotoflex Security Series brings advancements in stringent label inspection

Rotoflex has released the new Security Series for stringent label inspection and finishing. The fully integrated modules seamlessly integrate into the Rotoflex VSI, HSI and VLI product lines, either as a new equipment option or as a retrofit to existing installations.

11 Aug 2015

Your waste, your responsibility

Coschem held a lecture evening on 22 July 2015 on the topic of Hazardous waste management in South Africa. The talk outlined the steps cosmetics manufacturers should take to ensure they comply with legislation surrounding the responsible management of their waste streams.

06 Jul 2015

Offline coding a solution to FMD compliance

Pyrotec PackMark recently reminded pharmaceutical manufacturers who sell their products on the European market about the Falsified Medicines Directive (FMD). Producers will have to comply with this legislation from January 2016.