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

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

Pink Sheet

Brexit: New Rules Will Hit Parallel Trade From UK to EU

By Ian Schofield 23 Nov 2020

From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries. 

Topic EU Pharma-Brexit Brexit

Pink Sheet

Brexit: UK Joining US-Led Project Orbis To Speed Cancer Drug Approvals

By Neena ​ Brizmohun 23 Nov 2020

Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.

Topic Pharma-Brexit Brexit

Pink Sheet

UK Offers Pragmatic Approach To Safety Reporting From Jan 2021

By Vibha Sharma 09 Sep 2020

The UK’s approach to pharmacovigilance system requirements in the post-Brexit transition period will allow companies to leverage some of the existing structures put in place for EU systems.

Topic Pharma-Brexit Brexit

Pink Sheet

UK Set For January Brexit After Conservatives Win Election

By Ian Schofield 26 Aug 2020

The Conservative Party's victory in the UK general election means the Brexit withdrawal deal will be able to pass. The UK will leave the EU by 31 January and enter a transition period during which medicines regulation will remain broadly unchanged.

Topic Regulation Brexit Pharma-Brexit

Pink Sheet

Long-Awaited Brexit White Paper Lays Out UK’s Plans For Medicines Regulation

By Francesca Bruce 26 Aug 2020

The UK government has finally published its white paper on the UK’s future relationship with the EU following Brexit, to the relief of the pharmaceutical industry.

Topic Pharma-Brexit Brexit Regulation EU