News Category: Regulatory news
The UK left the European Union on 31 January 2020 on the basis of the Withdrawal Agreement which was agreed by the European Council on 17 October 2019.
The agreement includes a transition period until at least 31 December 2020.
The EU and the UK will start negotiations on a new future relationship agreement which, if agreed, is due to come into effect from 1 January 2021.
No matter what the final shape of Brexit looks like, the decision of the UK to leave the EU will result in some changes, both here in Ireland and for our EU partners, which we will continue to prepare for.
What does this mean?
- The EU and the UK are now in a transition period that will last until at least 31 December 2020. The period may be extended to 31 December 2021 or 31 December 2022 if the UK requests an extension before 30 June 2020.
- During the transition period, EU rules and regulations will continue to apply to the UK and the UK will remain part of the EU's Single Market and Customs Union. Further details are available from the European Commission website.
- While the UK remains part of the free trade block and subject to EU law during the transition period, it cannot act as lead Member State and cannot be part of the EU institutions.
In brief, for human and veterinary medicines, and medical devices, this means;
- The UK cannot act as Reference Member State (RMS) or Rapporteur but can act as a Concerned Member State (CMS).
- UK companies can continue to manufacture, batch test, batch release and hold MAs in respect of the EU and UK.
- Medical devices with a UK notified body (UK CE mark), UK legal representative or manufacturer can continue to be distributed across the EU and UK.
- Parallel trade from the UK is permissible.
- At the end of the transition period the UK will revert to the status of third country. This means that all pharma and medical device companies need to have completed their Brexit preparations. As the UK has now left the EU, companies should have all outstanding regulatory issues, if not already resolved, complete by 31 December 2020.
- During the transition period, the EU and UK will seek to negotiate a trade deal.
- In addition to any trade deal that is negotiated, the Withdrawal Agreement contains provisions on the future relationship, across a wide range of areas, between the EU and UK. These provisions take effect at the end of the withdrawal period.
Further Information and Updates
The HPRA shall continue to update stakeholders as further clarity emerges during trade negotiations, particularly with respect to industry specific implications of the Withdrawal Agreement and the Northern Ireland protocol. We recommend registering for HPRA web alerts to ensure routine access to updates.
More information relating to Brexit is available on the Brexit section of the HPRA website.
A checklist is available to download, which outlines key steps for the Brexit transition period.
The Government continues to publish a range of practical advice to help businesses and citizens around the country to prepare for Brexit. The latest information is hosted on the Government's main website at gov.ie/brexit.