After the United Kingdom’s exit from the European Union, the UK and EU established the Windsor Framework, aiming to restore the smooth trade flow within the UK’s internal market while at the same time safeguarding Northern Ireland’s position in the Union. So, under this new arrangement, the United Kingdom holds the authority to license all medicines, including those previously regulated under the EU Centralised Authorisation Procedure (EU CAP) across the entire UK.
Following the upcoming effective date which is 1 January 2025, business representatives have issued questions to the Health Products Regulatory Authority (HPRA). The latest Q&A was updated on 19 June 2024 including updated information about:
Joint labels between IE/UK
Medicines moving from Northern Ireland to the Republic of Ireland
The expiry of Breit Derogations approved in Ireland
Joint Labels for National Products between IE/UK
Joint outer labels and 2-d matrix serialization safety features as required by the Falsified Medicines Directive are not allowed for national products between IE/UK after the implementation date. All medicines products placed in Northern Ireland and Great Britain are compulsory to be labeled “UK Only” on the outer packaging.
Meanwhile, the inner packaging, immediate packaging, and information package leaflet are allowed to remain the same between IE/UK after the implementation date.
Nationally authorized products are not necessary to submit Article 61(3) application for HPRA assessment when:
Removing or changing the administrative information for EU member states or UK placed within the ‘blue box’
Removing a local representative for NI or UK in the product information updates
However, for products authorized through the centralized procedure, the Marketing Authorization Holders should submit the Article 61(3) application to the EMA.
Any joint packaging with the IE/NI or IE/UK labeling that has been approved pre-WF and contains UK information, is allowed to continue releasing the products on the Irish market for a temporary period. Marketing Authorization Holders must ensure to remove all NI/UK administrative details on the outer packaging or labeling by 31 December 2027. Note that this only applies to the outer carton with the immediate label and/or the package leaflet is jointly shared with the UK.
Medicines Moving from Northern Ireland to the Republic of Ireland
Based on Article 7 of Regulation (EU) 2023/1182, medicinal products as referred to Article 1(1) of the Regulation, authorized medicines intended to be placed on the market in Northern Ireland cannot be moved into IE or any other EU Member States and this means no parallel exports can be done.
The supply of packs from NI to IE as exempt medicinal products (EMPs) will also no longer be permitted where the packs have been placed on the NI market either in UK or NI labeled packs. However, products not intended for or placed on the NI market can continue to be wholesaled, manufactured, or batch-released from NI to the EU.
Medicines Moving from the Republic of Ireland to Northern Ireland
Any medicine movements from IE to NI is not considered as export from the EU. The movements should comply with the standard regulatory requirements.
Products manufactured and released by a Qualified Person of an importer/manufacturer established in NI will be considered as batch released for the EU market.
The Brexit Derogations
Derogations for medicinal products supplied to Cyprus, Ireland, Malta, and Northern Ireland were provided by the amended Directives 2001/20/EC and 2001/83/EC. Temporary derogations applicable in Cyprus, Ireland, and Malta while for Northern Ireland will expire on 31 December 2024. After the expiry date, all medicines released to the Irish market are required to comply with the standard EU regulations.
A Qualified Person may use the quality control data generated in the UK to batch-release product for the Irish market in 2025, under a derogation, before 11 pm of 31 December 2024. This product will be received under a Wholesaler’s Distribution Authorization in Ireland if it is dispatched during pre-year-end and can still be placed on the market post-year-end, as long as it is facilitated by a derogation before January 2025.
Contact us at info@arqon.com for more information.
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