New pharma guidelines published following Brexit
January 5, 2021
Following a year of negotiations, a trade deal between the UK and EU was agreed on 24 December 2020, and the final phase of Brexit was implemented at midnight on New Year’s Eve.
The new arrangements have wide-ranging implications on how both will continue to live, work and trade together, and include new rules and regulations for a multitude of industries including medicines and healthcare.
As part of these changes, the Medicines and Healthcare products Regulatory Agency (MHRA) is now the UK’s standalone medicines and medical devices regulator. The MHRA has published new guidance on the essential assessment routes for pharmaceutical products following Brexit.
In addition to the licensing of medicines and devices, the MHRA publications provide information on clinical trials, exporting active substances for medicines, importing medicines and investigational medicinal products, pharmacovigilance procedures and new IT systems.
The new guidelines will ensure vital regulatory affairs work can continue without delay while maintaining the high standards of quality control and efficacy that have already been established and are expected.
The full MHRA guidance and information documentation can be found here
For further information contact:
Jonathan Walmsley
E: jwalmsley@gandlscientific.com
T: 0203 143 2195
