The Health Products Regulatory Authority (HPRA) Ireland has published guidance regarding the key issues facing the HPRA and their stakeholders, in light of the withdrawal of the United Kingdom (UK) from the European Union (EU). The guidance brings welcome national agency information.
The implementation and details of any transitional period will depend on the outcome of the Brexit negotiations, however there have been discussions at EU level on the introduction of transitional arrangements.
The guidance from the HPRA is based on the assumption that there will be a hard Brexit and the UK will become a third country by 30th March 2019. In the lead up to Brexit the advice currently provided may require updating throughout the negotiations process.
The guidance from the HPRA contains information regarding medicines availability, joint labelling, post Brexit licensing scenarios for marketing authorisation holders, clinical trials, pharmacovigilance operations, GMP compliance, QC testing and batch release.
On joint packs the HPRA says that they recognise that the maintenance of joint labelling with other markets is key to retaining medicines on the Irish market – good news indeed for both the industry and Irish patients!
Where the UK is RMS and there is only one concerned member state (CMS), then that CMS will automatically become the new RMS. Therefore, in instances where Ireland is the CMS, the HPRA will become the RMS. Where there are two or more CMSs, the MAH can choose the new RMS; touting for business, the HPRA states that they are very willing to become the RMS for any product where currently the UK is RMS and Ireland is a CMS.
The HPRA, European agencies and all other stakeholders in the health products supply chain must plan for all eventualities including that the UK will fully exit the current regulatory system on 30 March 2019.
To read the HPRA’s full Brexit guidance, please click here.