For all your Regulatory Affairs challenges

News

Brexit Update: Ireland and Denmark to drop fees for RMS transfer post-brexit

The Danish Medicines Agency (DKMA) is following the footsteps of Irish regulator Health Products Regulatory Authority (HPRA) regarding the fees waiver for transfer of reference member state (RMS) for companies affected by Brexit. The decisions are based on the premise that there will be a hard Brexit and the UK will become a third country by 30 March 2019. It is also based on individual agency's current understanding of the potential legal impact of an exit by the UK. Consequently, companies with drugs approved under the MR/DC procedures that use UK as their RMS will need to transfer the RMS elsewhere.

There would however be certain regulatory considerations regarding the choice of new RMS and their eligibility such as only the countries that were part of the procedure or listed as CMS could be used and there should be no pending regulatory procedures with the earlier RMS in order to allow the transfer.

Please refer to the official guidance published by Health Products Regulatory Authority (HPRA) and The Danish Medicines Agency (DKMA) by referring to individual links.

If you are an existing MA holder and looking to carry out RMS transfer for your products please contact us using the customer enquiry form.