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Questions and Answers on the Windsor Framework and medicines for human use

The following Q&As are not a comprehensive overview of the implications of the Windsor agreement, rather we are answering questions received from companies. Any questions not included below should be addressed to brexit@hpra.ie and we will update this page accordingly.

The Windsor Framework (WF)

Windsor Framework implementation timelines

Joint labels for national products between IE/UK

Over-labelling of the 'UK only' label:

Over-labelling of the 'UK only' label and addition of the 2-D matrix serialisation safety feature:

Product moving between Northern Ireland and Republic of Ireland

The Brexit Derogations

To prevent shortages of medicinal products and ultimately to ensure a high level of public health protection, Directives 2001/20/EC and 2001/83/EC were amended to provide for derogations for medicinal products supplied to Cyprus, Ireland, Malta and Northern Ireland. It was clearly specified that to ensure uniform application of Union law in the Member States, that the derogations applicable in Cyprus, Ireland and Malta would be of a temporary nature only. Directive 2022/642/EC amended Directives 2001/83/EC and 2001/2/EC. The derogations approved in Ireland expired on 31st December 2024. After this time, all medicines released to the Irish market will need to be EU regulatory compliant. To assist MAHs with this change the following guidance is published.

Quality Control testing:

Batch release: