National Authority Guidance

HPRA

The Irish Health Authority released Brexit guidance for stakeholders on 03 January 2018. This document laid out the HPRA’s aim to support all stakeholders already on the market, their intention to take a pragmatic approach where possible and maintaining joint labelling to ensure medicines supply in Ireland.

HPRA have offered to waive RMS transfer fees in relation to Brexit where the required transfer criteria are met. This includes already being a CMS in a UK lead procedure and all pending applications being finalised prior to RMS transfer.

The full guidance document can be found here.

HPRA

DKMA

The Danish Medicines Authority released a statement on 01 February 2018 offering to waive any RMS transfer fees for marketing relating to Brexit on a first come first served basis. The DKMS has listed the following criteria:

  • Denmark must already be the CMS in the concerned procedure
  • All ongoing regulatory procedures where the UK is the RMS, e.g. variations, applications for renewal of marketing authorisations, must be closed before a switch can take place

The full press release can be found on the agency website here

DKMA

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