As you have heard, the United Kingdom has left the European Union. This has far-reaching consequences for the way medicinal products will be assessed in the future. Instead of being part of the European Union regulatory framework, the UK will independently assess and regulate medicinal products, and it won’t be business as usual. Until end of December 2020, a transition period is in place. This period ends January 1st, 2021 and from that day onward, there will be new rules.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidelines for industry on this matter. The guidelines can be found here.
Bronsing Life Science Consultancy will continue to provide the full range of services in the UK, ranging from Scientific Advice to Marketing Authorization Application.