Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no deal scenario.
The Agency is publishing a series of guidance documents for industry and other stakeholders covering our proposed arrangements for the regulation of medicines, medical devices and clinical trials, if we leave the EU with no deal.
We have added a link to updated guidance for manufacturers of biological medicines on NIBSC.org. The guidance addresses independent batch release in the United Kingdom following the UKs departure from the EU without a deal.