Brexit

The United Kingdom (UK) left the European Union (EU) on 31 January 2020. It became a third country on 1 February 2020. A transitional period lasting until 31 December 2020 was established in the agreement on the UK’s withdrawal. During this period – with some exceptions – the conditions and obligations laid down in EU law continued to apply for the UK. The transitional period has also expired and has not been extended.

As of 1 January 2021, EU pharmaceutical law as laid out in the ‘acquis communautaire’ still applies to Northern Ireland. The basis for this is the Protocol on Ireland/Northern Ireland. This Protocol forms part of the withdrawal agreement concluded by the EU and the UK that established the terms of the UK's withdrawal from the EU.

Implementation at the BfArM

As a result of Brexit, the Federal Institute for Drugs and Medical Devices (BfArM) has further expanded its commitment and capacities to take over authorisation and post authorisation procedures in the European network of medicines authorities. The BfArM has also intensified its activities in the areas of clinical trial authorisations, scientific advice, inspections, and pharmacovigilance.

The relevant European bodies have established Brexit working parties, which publish European decisions and FAQs on different topics on their websites. The BfArM fully supports the comments made available thus far and the decisions made at the European level.