The ever-changing COVID-19 regulatory landscape: The European Commission issues guidance on the manufacture of certain medical supply products for COVID-19
The regulatory environment for rapid production of COVID-19 medical supplies changes on a daily basis. Most recently, the European Commission has weighed in to provide some Europe-wide insight. The guidance provided only serves to underline the significant pressures that all of those in these areas are having to grapple with, as well as the considerable complexity of applicable regulatory regimes.
Sarah-Jane Dobson and Olivia Flasch
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.
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.
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.
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.