The Commission and the European Medicines Agency (EMA) restated the rules this week, warning that firms not “established in the EU” or conducting batch release and pharmacovigilance in the Union after the UK leaves in March 2019 are likely to face disruption.
The Commission said: “Marketing authorisation holders may be required to adapt processes and to consider changes to the terms of the marketing authorisation in order to ensure its continuous validity and exploitation, once the United Kingdom has left the Union.”
It urged companies to screen marketing authorizations to identify those that will need to be changed, advising them to do promptly to “avoid any impact on the continuous supply of medicines for human and veterinary use within the European Union.”
The Association of the British Pharmaceutical Industry (ABPI) – which represents more than 150 pharmaceutical firms – told us it would work with companies, regulators and government to make the transition as easy as possible and minimise disruption.
The industry group also reiterated its call on the UK Government to “secure co-operation with the EU on the regulation of medicines. This should achieve alignment between the UK and EU regulatory framework, to deliver proportionate, robust and effective regulation of medicines in the UK.”
The ABPI’s response is in keeping with comments it made before the referendum when it warned that after Brexit drug companies would prioritize the larger EU market and seek approval for their products in member states before the UK.
Brexit is likely to have a significant impact on Indian companies according to one regulatory consultant we asked.
He told us "Indian companies traditionally pick UK as one of the their main bases in EU. If UK will not be part of the CP/DCP/MRP approval system, then it will potentially spell big trouble for applicants wishing to keep a door open to expansion with dossiers outside the UK.
The full impact of Brexit will not be clear until the UK's status is setting he continued, explaining "If UK will get status similar to Norway/Iceland/Liechtenstein then things may look much brighter. Some companies are now actively seeking dialogue with agencies ex-UK, for example for scientific advices and discussion of DCP/RMS submission slots."