G&L reflects on the new MHRA legislation ahead of Brexit
We examine the implications of a no-deal Brexit agreement with just six weeks to go until the UK leaves the EU.
While a deal is still being ironed out, many business leaders and political commentators are warning of massive detrimental impacts both economically and socially if the UK formally removes itself from the trade agreements, which have operated since 1973, without agreement.
With deal deadlines looming and passing regularly, there is tangible trepidation of a so-called ‘double whammy’ as the economy, already ailing under the effects of the Coronavirus pandemic, could be further impacted by new barriers and tariffs by our former EU colleagues.
The implications of no-deal will reach far and wide, with no sector left unscathed. The Regulatory Affairs and Quality Assurance industries are already among the most stringently legislative, and this could increase even further with new customs and registrations laws now being faced for the first time in almost 50 years.
Delays in healthcare are costly and not just financially. They must be avoided, especially as we stand on the edge of ground-breaking advancements in the fight against Coronavirus and other illnesses.
G&L Scientific has welcomed the announcement that as of January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator and has published new guidance on the vital assessment routes for pharmaceutical products following Brexit.
As well as the licensing of medicines and devices, the document gives welcome direction on clinical trials, exporting active substances for medicines, importing medicines and investigational medicinal products, pharmacovigilance procedures and new IT systems.
At G&L Scientific, we take great pride in our unrivalled local knowledge combined with our ability to operate on a global basis. This new guidance allows us to continue our work, and it will be critical going ahead as we prepare for the significant changes the industry will face in 2021 and will allow our work to continue unfettered at this crucial time.
Further information on MHRA guidelines can be found here
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