The MHRA has published information for pharmaceutical companies preparing for the end of the Brexit transition period.
The guidance provides some information on how to operate from 1 January 2021, including on licensing of medicines and devices, clinical trials, exporting active substances for medicines, importing medicines and investigational medicinal products, pharmacovigilance procedures and new IT systems.
Companies will welcome the important detail included in this guidance which will support them in planning for the end of the transition period.
Whilst the guidance is largely similar to the Brexit ‘no deal’ guidance published in 2019 (which was withdrawn as a deal was secured), there are some additions relating to the added complexity of the Northern Ireland protocol and a more time-restricted acceptance of EU batch testing and release. The ABPI will continue to seek more engagement with the Government in these areas.
In response, Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry, said:
“Our members will be reassured that Government has provided some critical information to help them continue preparations for the end of the transition.
“Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. If we are to ensure uninterrupted supply for the NHS from January, the MHRA must continue to work closely with them on details related to individual medicines as well as on issues related to the Northern Ireland Protocol and other areas of regulation.
“However, we have always said that the best way to avoid disruption in the long term is for both sides to consider the impact on patients in the UK and the EU and agree a deal.”
What is needed
Pharmaceutical companies are still waiting for the MHRA to provide additional technical information on other issues such as the handling of Decentralised [DCP] and Mutual Recognition Procedures [MRP], how variations to Marketing Authorisations (MAs) will be handled and new assessment routes from 1 January 2021.
Companies are also still waiting for detailed guidance on the regulation of medicines in Northern Ireland.
Even with the guidance published today pharmaceutical companies are going to face a significant change in the way they need to operate and will have to work through the practicalities of implementing the guidance. The MHRA will need to be available to work through the detail on an individual company basis, given the complexity of medicines regulation.
In the future
Alongside planning for the end of transition, industry is working with the MHRA to ensure that the UK remains at the forefront of medicines regulation.
By expanding the work it does with other regulators around the world to quickly adopt new breakthroughs, exploring new routes for approving medicines and aligning standards with the best in the world, the UK would be an attractive destination for pharmaceutical companies to submit their research.