Ireland’s Health Products Regulatory Authority (HPRA) has outlined conditions in which Marketing Authorisation Holders (MAHs) can apply for a time-limited conditional exemption to the implementation of new rules following Brexit.
Following the end of the transition period, the European Commission (EC) published a notice entitled “Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period.” The notice acknowledges that the historic dependence of Ireland, Malta, Cyprus and Northern Ireland on medicines supplied from GB combined with the exceptional circumstances of the COVID-19 pandemic, mean an additional period of up to a year (January 2021 – 31 December 2021) to transfer crucial functions to the European Union (EU)/European Economic Area (EEA) has been agreed.
Exemptions principally revolve around:
- Lack of operators holding the required marketing authorisation (MA) for importing medicinal products/investigational medicinal products (IMPs) from third countries. As long as the relevant quality standards are upheld (such as batch testing), medicines and IMPs can be imported from GB and placed on the market in any of the dependent states during the exemption period.
- Requirements relating to the placement of the unique identifier (UI) for medicinal products for human use. At present, exporters taking products from the EU to any third country like the UK must decommission any UIs and any importers must affix new ones. However, the lack of available importers with an MA in the historically dependent states means this requirement is also subject to a temporary exemption in those countries.
As a result of this notice and its conditions, the HPRA has now released information on how to apply for this time-limited conditional exemption in Ireland. Initially, applicants must submit a request form to the HPRA via Brexit@hpra.ie. Approvals are based on the information provided by the applicant hence it should be detailed and completed according to the instructions provided within the form.
If accepted by the HPRA, exemptions apply only to medicinal products/investigational medicinal products supplied to the Irish market and clinical trials being carried out in Ireland. Granted exemptions require the applicant to keep the HPRA regularly updated on their progress towards compliance. Exemptions will expire by 31 December 2021.
Note that there are no fees for exemption requests.
To view full details of the exemptions, click here.