Pink Sheet

UK Explains New Reliance Routes To Approval Based On EU Dossiers

By Ian Schofield 27 Jan 2021

Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.

Topic Brexit Pharma-Brexit

Pink Sheet

UK BIA To Push For Post-Brexit Regulatory Agreement With EU

By Ian Schofield 27 Jan 2021

There may not be a great deal in the new UK-EU trade and cooperation deal for the life sciences industry but a new working group could act as the forum for constructive discussions on regulatory cooperation.

Topic Regulation Brexit Pharma-Brexit

Medtech Insight

UK All-Party Report Assesses Brexit Medtech Impact While Germany Worries Over Border Delays

By Ashley Yeo 27 Jan 2021

Government and industry in the UK are determined to make the best of the Brexit free trade deal, but German medtechs are eager for trade flow practicalities to be prioritized.

Topic Brexit Medtech-Brexit

Pink Sheet

How The UK Regulatory System Would Work In A No-Deal Brexit – Part 1

By Ian Schofield 27 Nov 2020

Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.

Topic Pharma-Brexit Brexit Regulation

Pink Sheet

Desperate Measures: How To Soften The Impact Of No-Deal Brexit

By Ian Schofield 27 Nov 2020

Building more cold chain warehouses, finding alternative sources of medicine supplies, and halting parallel exports to mitigate product shortages. Just some of the ideas for tackling the consequences of a no-deal Brexit scenario put forward by industry representatives at a recent parliamentary committee hearing.

Topic Pharma-Brexit Brexit EU

Medtech Insight

BSI Continues UK CE Marking Operations Until Year End

By Amanda Maxwell 27 Nov 2020

There has been quite a lot of conjecture over whether UK notified bodies would have to cease their CE marking operations on Brexit day, 31 January, or whether they would be able to continue until the end of the EU/UK withdrawal agreement. BSI's Gary Slack explains that BSI, for one, is still open for business. 

Topic EU Brexit

Medtech Insight

Brexit Response: Patient Safety Prioritized In Forthcoming UK MHRA Device Regulatory System

By Ashley Yeo 27 Nov 2020

Although the EU MDR and IVDR will fall outside the scope of new post-Brexit medtech regulations for Great Britain in 2021, the UK MHRA says it has the chance of developing its own world-leading regulatory regime.

Topic Medtech-Brexit Regulation Brexit

Medtech Insight

Brexit: Medical Supplies Facing ‘Significant Disruption’ At Ports

By Ian Schofield 27 Nov 2020

As negotiators struggle to reach agreement on the future UK/EU relationship following Brexit, suppliers have been warned to expect major hold-ups next year for medical products crossing the English Channel.

Topic EU Brexit

Pink Sheet

BIA Sees Some Hope For Regulatory Alignment After Brexit

By Ian Schofield 27 Nov 2020

Could the UK carry on playing a part in the European Medicines Agency from 2021? Much will depend on the complex negotiations on the future relationship that are expected to kick off in March. 

Topic Brexit EU