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Thursday, 18.04.2024, 18:49
Lithuania to incur 200,000 euros medicine registration burden after Brexit
The Lithuanian government estimates that 200,000 euros in additional
funding will be needed for the purpose from the next year's budget.
Lina
Businskaite-Sriubene, spokeswoman for the Lithuanian health minister,
told the UK has so far played an important role in processing applications for
registering medicines, applying mutual recognition and decentralized
procedures, and has often carried out the role of the reference state which
carries out the primary assessment.
The European Medicines Agency which issues permission to market medicines
in the EU is based in London, and the UK has been actively participating in the
agency's activity.
"After the UK leaves the EU, other EU member states will have to
take over its functions in the medicine sector, for example, take over the
reference state function which the UK has carried out so far and accept new
applications for the registration of medicines. And the European Medicines
Agency will be moved to the Netherlands," Businskaite-Sriubene told.
In her words, after the UK leaves the EU, Britain will no longer be
subject to the common market principles on medicines, therefore, the remaining
member states will have to review their medicine registries and the cases of
medicines registered in the UK to ensure that UK-produced medicines are
imported and legal persons established in the EU and having a production
license.