16 March 2021
In the wake of the UK’s agreed deal with the EU, Andrew Howard, Deputy Director for Trade, Regulation and Analysis in the Office for Life Sciences, offers advice to those life sciences businesses navigating the transition to a new regulatory landscape.
The UK has agreed a deal with the EU that supports continued regulatory cooperation to promote public health, engender patient safety and help ensure medicines and medical devices continue to be available both here and in Europe.
It includes an agreement to recognise Good Manufacturing Practice (GMP) inspections and the sharing of information, as well as establish a medical product working group that is empowered to exchange regulatory information. We are confident that the deal will support our ambition for the UK to be the best place in the world to develop and launch innovative medicines, technologies and diagnostics for the benefit of patients and businesses alike.
As with any major change there will be bumps in the road and challenges to overcome. With an investment of £4 billion, the UK Government has laid the groundwork to minimise disruption and give traders time to adjust to new processes. New border controls will be introduced in three stages until 1 July 2021,1 with simplified Rules of Origin procedures. These have been temporarily agreed with the EU until the end of December 2021, by implementing a 12-month waiver on supplier declarations. The flow of critical goods, such as vaccines and vital medicines, has been safeguarded by increasing freight capacity, so that no one need worry about food, medicine or vital supply chains.
Many UK pharmaceutical companies have already taken the necessary steps to operate under the new rules around exports, imports, tariffs, data, hiring and travel. For those companies yet to take action, there is a wealth of support available.2
If you move goods into, out of or through Northern Ireland, check the guidance and find help and support on GOV.UK:
In addition, make sure that you stay abreast of the latest COVID-19 guidance that may affect your business, such as changes to travel corridors.3
The UK has a highly ambitious strategy for life sciences, written in collaboration with industry and underpinned by a government commitment to create a global hub for life sciences in the UK. It sets out a plan to harness the UK’s competitive advantages in life sciences so that we remain a global leader and seize emerging opportunities.
The EU-UK deal means the UK can now regulate in a way that suits the UK economy and UK businesses – doing things in a more innovative and effective way. But businesses should act now to take advantage of the opportunities this change brings. Internationally, the UK will operate an independent trade policy for the first time in 50 years, creating new opportunities for exporters and delivering better choice and value for consumers. The best place for businesses to get support is GOV.UK/transition.
For any further queries please contact the business support helpline, 0800 998 1098, Monday to Friday, 9am to 6pm. Alternatively, contact Find Business Support Scotland: 0300 303 0660, Business Wales Helpline: 0300 060 3000 or the Invest Northern Ireland helpline: 0800 181 4422.
Andrew Howard is Deputy Director for Trade, Regulation and Analysis in the Office for Life Sciences, a joint office of the Department for Business, Energy and Industrial strategy and the Department of Health and Social Care at the UK Government.
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