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United Kingdom’s withdrawal from the European Union (‘Brexit’)
One of the consequences of Brexit is that EMA will relocate to Amsterdam, the Netherlands, where it has to take up its operations on 30 March 2019 at the latest.
EMA is working on the scenario that the UK will become a third countryas of 30 March 2019. As a consequence, the UK will no longer be able to engage as (co)-rapporteurfor new marketing authorisation applicationsfor which the centralised procedurewould finish after 30 March 2019.
Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders – Revision 3
From 18/08/2018 the draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders – Revision 3 is available for consultation until 17/02/2019.
As described by EMA, it should be read in conjunction with other EMA and ICH guidelines.
The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support of a monotherapy claim on a case-by-case basis, the inclusion of new sections on neonates and status epilepticus and other changes related to paediatric developments. This guideline provides assistance for the development and evaluation of medicinal products for the treatment of epilepsy in adults and children. The scope of this document is restricted to treatment of seizures in epileptic disorder although there are some remarks concerning non-seizure features of epilepsy syndromes.