Recital (46) · Regulation (EU) 2025/2645

(46)On 1 February 2020, the United Kingdom of Great Britain and Northern Ireland (the ‘United Kingdom’) withdrew from the Union. The Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community^note (the ‘Withdrawal Agreement’) was concluded between the Union and the European Atomic Energy Community, of the one part, and the United Kingdom, of the other part. It was approved by Council Decision (EU) 2020/135^note on 30 January 2020, and entered into force on 1 February 2020. The Withdrawal Agreement provided for a transition period which ended on 31 December 2020. At the end of the transition period, Union law ceased to apply to the United Kingdom, whilst the Protocol on Ireland / Northern Ireland (the ‘Windsor Framework’), which forms an integral part of the Withdrawal Agreement, became applicable. In accordance with Article 5(4) of the Windsor Framework and point 7 of Annex 2 to the Windsor Framework, Regulation (EC) No 816/2006, as well as legal acts of the Union implementing, amending or replacing that legal act, apply to and in the United Kingdom in respect of Northern Ireland. Considering that the amendments to Regulation (EC) No 816/2006 would be applicable to and in the United Kingdom in respect of Northern Ireland in accordance with the Windsor Framework and that the competent authorities of the United Kingdom should continue to exercise their responsibility for issuing compulsory licences in respect of Northern Ireland, it is appropriate to stipulate that the procedure for granting a Union compulsory licence, and a Union compulsory licence granted under that Regulation, should not apply to or in the United Kingdom in respect of Northern Ireland. However, the United Kingdom in respect of Northern Ireland should ensure that the products manufactured under such a licence are not reimported into the territory of the Union or Northern Ireland, in accordance with Article 13 of Regulation (EC) No 816/2006, and should take necessary actions to that end in accordance with Article 14 of that Regulation.

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Defined terms · 8

Show every defined term

competent advisory body
means the advisory body competent under a Union crisis or emergency mechanism as listed in the Annex or, where applicable, the ad hoc advisory body referred to in Article 6(5);
crisis or emergency mode
means a crisis or emergency mode listed in the Annex, which has been declared pursuant to a Union crisis or emergency mechanism;
crisis-relevant product
means a product that is indispensable for responding to a crisis or emergency in the Union, or for addressing the impact of a crisis or emergency in the Union;
customs authorities
means customs authorities as defined in Article 5, point (1), of Regulation (EU) No 952/2013 of the European Parliament and of the Council.
protected invention
means any invention protected by any of the intellectual property rights referred to in Article 2(1);
relevant activities
means the act of manufacturing, namely making, or the act of marketing, namely using, offering for sale, selling or importing;
right holder
means the holder or holders of any of the intellectual property rights referred to in Article 2(1);
Union compulsory licence
means a compulsory licence granted by the Commission to exploit a protected invention in order to carry out in the Union relevant activities concerning crisis-relevant products or processes required to manufacture those products;