Category: Regulation & compliance
Extraordinary Times, Extraordinary Measures: How to become a medical supply manufacturer in Europe in the times of the COVID-19 pandemic
The extraordinary times we find ourselves in during the global COVID-19 crisis has led to extraordinary measures being taken by product manufacturers and suppliers across the globe. Regulatory bodies and governments around the world are taking equally unprecedented measures.
Adapting to the New World
An update on how the Cooley products team is responding to the changes brought on by COVID-19.
Disruption caused by COVID-19
We all hope that the predictions about the spread and seriousness of COVID-19 (coronavirus) prove to be unfounded. Whatever course the development of the virus takes, many of the measures that have been taken or are under consideration by governments, businesses and other organisations are already having or will have a significant effect on commercial relationships and commercial life generally.
No chance of makeup – Brexit update for cosmetics companies in the EU and UK
Sarah-Jane Dobson
Due to some unique aspects of the EU Cosmetics Regulation compared to other EU product safety regulations, the cosmetics industry has been particularly impacted by Brexit. Given that Brexit has now taken place, it is timely to reconsider this ongoing impact on industry and provide some guidance on forward-looking planning.
The Regulator: European Commission sets out approach on the future regulation of AI
Jamie Humphreys and Tracey Bischofberger
The European Commission released its proposals on a future regulatory framework for AI, favouring mandatory risk-based requirements for high-risk applications, along with targeted amendments to existing EU safety and liability legislation.
The MHRA make it clear: the UK will take a backseat in EU’s medicine licensing regime post-Brexit
Sarah-Jane Dobson
On 18 February 2020, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), updated its guidance on medicine licensing post-Brexit “Apply for a licence to market a medicine in the UK”. The update provides further clarity on the UK’s status in the licensing process now that Brexit has taken place.
E-labelling: are EU ready for the digital age yet?
Tracey Bischofberger and Julia Maskell
A new public consultation on the labelling of fragrance allergens could open the door to e-labelling in the EU.