The Danish Medicines Agency (DKMA) has offered to omit reference member state (RMS) transfer fees for companies who are affected by Brexit. It is likely that the United Kingdom (UK) will become a third country in March 2019, therefore companies with drugs approved under the mutual recognition and decentralised procedures that use the UK as their RMS will need to move their records to another agency based in the European Union (EU). The Health Products Regulatory Authority in Ireland is also allowing marketing authorisation holders to make them the RMS for free.
However there are some limitations, due to European rules, on which countries companies can pick as their RMS. For example, the new RMS must already be involved with the approved drug as a concerned member state. Before a transfer can take place, all ongoing regulatory procedures where the UK is the RMS, such as variations and applications for renewal of marketing authorisations, must be completed.
It may be that Danish and Irish regulators are willing to waive their fees as part of a plan to claim regulatory ground which is currently held by the UK, and to attract companies who are affected by Brexit.
For further information regarding changing the RMS to the DKMA, please click here.
If you require help with your regulatory Brexit strategy or activities, please contact our regulatory team via our Contacts page.