Decision of the UK to withdraw from the European Union
At the end of March 2017, the United Kingdom (UK) notified the European Council that it intends to withdraw from the European Union (EU). Together with other Member States and the European Medicines Agency (EMA), the HPRA is making preparations to ensure that we continue to deliver on our patient and animal health remit even if the UK fully exits the current systems on 29 March 2019.
The UK continues to play a full role within the European regulatory network during the ongoing discussions in relation to its withdrawal from the EU. Although the eventual outcomes of these negotiations are unknown, there are potentially significant implications for the European network as a whole and particularly for Ireland with its shared market place.
Protecting the availability of medicines for Irish patients and the integrity of our market are key strategic aims of the HPRA’s Brexit-related activities while also optimising our role within the European regulatory network and maintaining our strong working relationships with UK colleagues.
The HPRA has established an internal working group under the direction of Rita Purcell, Deputy Chief Executive, to ensure that we are prepared for the UK’s withdrawal from the EU. The HPRA will provide information on this dedicated section of our website to keep stakeholders informed of developments. This includes the publication of a detailed Brexit guidance document for human and veterinary medicines (last updated 18 October 2018).
Stakeholders should check these pages regularly for further guidance and updates in respect of the product areas highlighted below. Companies wishing to discuss any aspect of their operations related to the UK’s withdrawal from the EU should submit their queries to email@example.com.
Update 17 August 2018: UK technical announcement on the withdrawal agreement
The HPRA acknowledges the UK Government’s technical announcement on how the implementation period under the withdrawal agreement will operate. The document is explained on its website as follows:
“This document sets out what recent developments, such as agreement on the terms of an implementation period would mean for the life sciences sector, once finalised as part of the Withdrawal Agreement”
While the HPRA believes that a transition period will be very helpful in managing the impact of Brexit for both UK and European stakeholders, we must advise caution on relying solely on an implementation / transition arrangement at this point. While there is broad political support across the EU for the transition period, it is dependent upon the successful completion of the ongoing negotiations between the EU and the UK over the Withdrawal Agreement. As such an outcome cannot be guaranteed at this point, the advice of the Commission and EU medicines network, including the HPRA, is that companies should plan on the basis that the UK becomes a full third country on 29 March 2019.
In particular, given the critical role of medicines and medical devices for European patients and animal health, it is recommended that companies have contingency plans that are based on a potential ‘no agreement’ outcome. It is expected that the position in relation to the Withdrawal Agreement will have greater clarity in the coming weeks and the HPRA will communicate further as information becomes available.
Our Commitment to Supporting Stakeholders
The HPRA would like to re-iterate its commitment to supporting all stakeholders in managing the regulatory and operational implications arising from Brexit. In particular, the HPRA and Ireland are:
- Willing and prepared to take over the role of RMS where a change in RMS is required. There will be no fee for this service. In addition, the HPRA is open to acting as RMS for new marketing authorisation applications and invites applicants to contact us to discuss planned applications.
- Willing to work with companies who need to transfer some or all of their operations to Ireland to access the EU market.
- Planning to continue to work with our UK colleagues after Brexit to help maintain, where possible, dual labelling for products that are on both the UK and Irish markets.
- Exploring opportunities for dual labelled packaging with other European markets.
- Open to discuss pragmatic or innovative solutions to individual regulatory issues, such as, for example, older nationally authorised products and bulk transfers.
- Planning to increase our commitment to assessment within the centralised network and for new outgoing MRP/DCP.
- Actively facilitating the continued supply of critical medicines to the Irish market to ensure patient care.
- Participating in both the EMA and the HMA fora for Brexit preparedness and seeking to ensure that the specific needs of the Irish market are recognised and addressed.
The HPRA recognises that there is still uncertainty over the outcome of the Brexit negotiations but we are planning on the basis that the UK becomes a third country in April 2019. This approach will allow us to manage all eventualities from a soft to a hard Brexit. However, it is critical that companies also engage in this process. The HPRA’s commitment to supporting stakeholders is dependent on companies engaging with us on a timely basis. We are willing to use existing resources and increase resources to meet the commitments expressed above, but to deliver on this industry will need to give regulators timely and advance notice of their plans so we can prepare accordingly.