Tag: UK
COVID-19: Weekly Life Sciences Digest – International Collaboration and New Guidance in the EU and UK
Sarah-Jane Dobson, Edward Turtle and Julia Maskell
With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.
The right to be recognised, rebooted: Regulation (EU) 2019/515 on the mutual recognition of goods starts to apply
Claire Temple, Edward Turtle and Olivia Flasch
The EU’s new regulation on the mutual recognition of goods has started to apply. One part of the so-called “Goods Package”, it aims to improve the application of the mutual recognition principle for goods and remove unjustified barriers to trade within the EU.
COVID-19: Weekly Life Sciences Digest – Guidance for Industry in EU, UK and US
Natasha Leskovsek, Sarah-Jane Dobson, Edward Turtle, Harriet Jones and Julia Maskell
With COVID-19 heralding unprecedented changes in the sector, our life sciences products experts provide a weekly summary of key international developments to keep you up to date.
The EU delays application of its new medical devices regime
Sarah-Jane Dobson and Ross Lennox
The EU has decided to postpone application of its new medical regime by one year. Although COVID-19 is cited as the reason, the delay is no doubt welcomed by an industry that has lobbied for postponement of the regime for some time because of perceived issues with its implementation.
RED Talk: EU consulting on proposed laws to deal with software that alters the safety or compliance of connected devices
Tracey Bischofberger and Alicia Johnson-Cole
The European Commission is holding a targeted consultation on proposed new laws to deal with software that alters the safety or compliance of connected devices. The consultation closes on 22 May 2020.
2020 ICPHSO Annual Meeting and Training Symposium: key highlights
Jamie Humphreys and Carol Holley
Product safety professionals from around the globe attended the ICPHSO Anunal Symposium in Orlando. We are pleased to bring you some of the highlights coming out of the many interesting sessions.
UK-specific guidance for manufacture and supply of certain medical devices for COVID-19
As noted in our previous overview article, it is vital that interested companies continue to monitor and strategically act on the rapidly changing government position on the regulation of specific medical supply product types in the context of COVID-19.
COVID-19 and consumer rights in the UK
Jamie Humphreys and Carol Holley
Considerations for UK companies regarding the significant impact the ongoing restrictions will have on businesses and their consumers.
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 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.