Article 12 of the Regulation (EU) 2023/1182 states that “Medicinal products that have been lawfully placed on the market in Northern Ireland before the date of application referred to in Article 14, and that are not repackaged or relabelled after that date, may be further made available on the market in Northern Ireland until their expiry date without being required to comply with the specific rules laid down in Articles 3, 4 and 5.”

NOTE: We strongly recommend that OBPs DO NOT UPLOAD any packs on the 31 of December 2024 as the cut-off point will be at 23h00 GMT on 31 December 2024, should Regulation (EU) 2023/1182 enter into force on 1 January 2025*.

*The date is subject to the relevant written guarantees from the UK being in place.