Regulation 2020/561 (Regulation) was passed by the EU in April last year to take account of issues raised by the COVID-19 pandemic and to defer the date of application of certain provisions of Regulation 2017/745 (MDR) by one year. The Regulation was published on 24 April 2020 through an EU accelerated procedure, and although the … Continue Reading
The EU-UK Trade and Cooperation Agreement (the Agreement), announced just before Christmas, has now been agreed by the UK Parliament and EU Commission. This is now in place with a requirement for further approval by the EU Parliament. The Agreement is wide-ranging but in terms of trade mainly focusses on the supply of goods. As … Continue Reading
The UK Cabinet Office released a statement last Thursday 5th November 2020 that could provide some breathing space for the UK/EU pharmaceuticals sector during the Brexit transition, by indicating that a one year implementation period would apply to application of the protocol for certain matters. For the pharmaceuticals sector, these include batch testing, importation and … Continue Reading
The work of UK health and regulatory authorities has mainly been targeted on COVID-19 work over recent months but there has been an increasing focus on End of Transition work in recent week’s and given that the Brexit transition period ends at 11pm on 31st December 2020 (GMT). As part of this work, UK MHRA … Continue Reading
