Regulation 2022/641 - Amendment of 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 - Main contents
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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| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2022/641 |
| Original proposal | COM(2021)998  |
| CELEX number i | 32022R0641 |
| Document | 12-04-2022; Date of signature |
|---|---|
| Signature | 12-04-2022 |
| Effect | 31-01-2022; Application See Art 2 20-04-2022; Entry into force Date pub. See Art 2 |
| End of validity | 31-12-9999 |
20.4.2022 |
EN |
Official Journal of the European Union |
L 118/1 |
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 168(4), 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 Union’s 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 Union’s pharmaceutical acquis in those markets with regard to investigational medicinal products. That Notice ceased to apply on 31 December 2021. |
(2) |
In accordance with the Protocol on Ireland/Northern Ireland (the ‘Protocol’), which forms an integral part of the Withdrawal Agreement, the provisions of Union law listed in Annex 2 to the Protocol apply, under the conditions set out in that Annex, to and in the United Kingdom in respect of Northern Ireland. That list includes Chapter IX of Regulation (EU) No 536/2014 of the European Parliament and of the Council (6) regarding the manufacturing and import of investigational medicinal products and auxiliary medicinal products. Therefore, investigational medicinal products used in clinical trials in Northern Ireland are to comply with those provisions of Union law. |
(3) |
Regulation (EU) No 536/2014 lays down the rules for investigational medicinal products intended to be used in clinical trials in the Union. That Regulation applies from 31 January 2022. |
(4) |
In accordance with Article 61(1) of Regulation (EU) No 536/2014, read in conjunction with the Protocol, the import of investigational medicinal products from third countries into the Union or Northern Ireland is subject to the holding of a manufacturing and import authorisation. Cyprus, Ireland, Malta and Northern Ireland have historically relied on the supply of medicinal products, including investigational medicinal products, from or through parts of the United Kingdom other than Northern Ireland, and the supply chains for those markets have not yet been fully adapted to comply with Union law. To ensure that clinical trial participants in Northern Ireland, as well as in Cyprus, Ireland and Malta continue to have access to new, innovative or improved treatments, it is necessary to amend Regulation (EU) No 536/2014 to provide for a derogation from the requirement of the holding of a manufacturing and import authorisation for investigational medicinal... |
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