Diario Oficial de la Unión Europea del 20/4/2022 - Sección Legislación
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Source: Diario Oficial de la Unión Europea - Sección Legislación
EN
20.4.2022
Official Journal of the European Union
L 118/1
I
Legislative acts
REGULATIONS
REGULATION EU 2022/641 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 12 April 2022
amending Regulation EU No 536/2014 as regards a derogation from certain obligations concerning investigational medicinal products made available in the United Kingdom in respect of Northern Ireland and in Cyprus, Ireland and Malta Text with EEA relevance
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 1684, point c, thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee 1, After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure 2, Whereas:
1
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 3 the Withdrawal Agreement was concluded on behalf of the Union by Council Decision EU 2020/135 4 and entered into force on 1 February 2020. The transition period referred to in Article 126 of the Withdrawal Agreement, during which Union law continued to apply to and in the United Kingdom in accordance with Article 127 of the Withdrawal Agreement, ended on 31 December 2020. On 25 January 2021, the Commission issued a Notice 5 on the application of the Unions pharmaceutical acquis in markets historically dependent on medicinal products supply from or through Great Britain, namely Cyprus, Ireland, Malta and Northern Ireland, after the end of that transition period. That Notice includes explanations of how the Commission was to apply the Unions pharmaceutical acquis in those markets with regard to investigational medicinal products. That Notice ceased to apply on 31 December 2021.
1 Opinion of 24 February 2022 not yet published in the Official Journal.
2 Position of the European Parliament of 7 April 2022 not yet published in the Official Journal and decision of the Council of 12 April 2022.
3 OJ L 29, 31.1.2020, p. 7.
4 Council Decision EU 2020/135 of 30 January 2020 on the conclusion of 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 OJ L 29, 31.1.2020, p. 1.
5 Commission Notice Application of the Unions pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period 2021/C 27/08 OJ C 27, 25.1.2021, p. 11.
