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Regulatory Focus™ > News Articles > 2019 > 3 > UK’s NIBSC Updates on No-Deal Brexit Plans

UK’s NIBSC Updates on No-Deal Brexit Plans

Posted 07 March 2019 | By Michael Mezher 

UK’s NIBSC Updates on No-Deal Brexit Plans

With less than a month remaining before the UK exits the EU, the UK’s National Institute for Biological Standards and Control (NIBSC) on Thursday provided an update in the event of a no-deal Brexit scenario.
 
In the update, the NIBSC, which produces and distributes a wide range of biological reference materials and functions as the UK’s official medicines control laboratory for biological products, says that while a Brexit deal “remains the Government’s top priority” it is accelerating its no-deal planning.
 
Despite the increasing prospect of a no-deal Brexit, NIBSC says it does not “anticipate significant difficulties in the supply of [its] products in Europe or elsewhere” as most are shipped by air freight. Companies and institutions within the UK are also advised that there should be no changes to delivery arrangements regardless of whether a Brexit deal is made.
 
NIBSC also conducts research on biotherapeutics, bacteriology and virology, some of which is funded by the EU through the Horizon 2020 research and innovation framework.
 
“Following the UK’s exit from the EU, NIBSC will remain committed to this program and will endeavor to fulfil its obligations under all existing and proposed research collaboration agreements. This will also be the case if the UK leaves the EU without a deal,” NIBSC says.
 
NIBSC also says it will manage its relationships with funding programs under Horizon 2020 according to the Horizon 2020 Framework Program for Research and Innovation (EU Exit) Regulations 2018, which revokes portions of the EU legislation for Horizon 2020.
 
The UK is currently considering whether to create its own research fund similar to Horizon 2020 to address concerns that UK-based institutions will suffer funding losses if future EU grants and other funding sources are restricted after Brexit. The details for the EU’s next major research funding framework, Horizon Europe, are still being worked out and it is unclear whether changes to the framework will make it more difficult for non-EU entities to receive grants.
 
Updates: Reference Materials, Science & Research

To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe.

 

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