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.
New guidance has been added to the page. This guidance explains the steps companies will need to take to register new artwork for medicines packaging as a result of new marketing authorisations being issued in the event the UK leaves the EU without a deal.
New no deal guidance has been added to the page on procedures for UK-PIPs in the event the UK leaves the EU without a deal
New guidance on registration of clinical trials for investigational medicinal products and publication of summary results if the UK leaves the EU without a deal.
Added a link to a new guidance page on licensing of biological products: biosimilars, ATMPs and PMFs in a no deal scenario.
Added links to new guidance covering marketing authorisations, centrally authorised products and other information about medicines and medicinal products licensing.
Added new guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) if the UK leaves the EU without a deal.
Added a new section on importing and exporting in a no deal scenario.
New section on Vigilance and Risk Management added to the page in addition to a new guidance document which addresses Completed Paediatric Studies - submission, processing and assessment in the event of a no deal scenario.
Added links to two new statements from NIBSC, covering information for customers of biological reference materials and information for collaborators.
Added link to guidance on making submissions to the MHRA in a no deal scenario.
New guidance on regulating medical devices in the event of a no deal scenario added to the page.
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.