Regulation 2023/1182 - Specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland - Main contents
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official title
Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2023/1182 |
| Original proposal | COM(2023)122  |
| CELEX number i | 32023R1182 |
| Document | 14-06-2023; Date of signature |
|---|---|
| Publication in Official Journal | 20-06-2023; OJ L 157 p. 1-7 |
| Signature | 14-06-2023 |
| Effect | 21-06-2023; Entry into force Date pub. +1 See Art 14 01-01-2025; Application See Art 14 And 52024XC07473 |
| End of validity | 31-12-9999 |
20.6.2023 |
EN |
Official Journal of the European Union |
L 157/1 |
REGULATION (EU) 2023/1182 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 14 June 2023
on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC
(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 (the ‘Withdrawal Agreement’) was concluded on behalf of the Union by Council Decision (EU) 2020/135 (3) 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. |
(2) |
The Protocol on Ireland/Northern Ireland (the ‘Protocol’) forms an integral part of the Withdrawal Agreement. |
(3) |
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 Directive 2001/83/EC of the European Parliament and of the Council (4) and Regulation (EC) No 726/2004 of the European Parliament and of the Council (5). Therefore, medicinal products placed on the market in Northern Ireland are required to comply with those provisions of Union law. |
(4) |
Directive 2001/83/EC lays down rules for medicinal products for human use and Regulation (EC) No 726/2004 lays down Union procedures for the authorisation of medicinal products for human use. |
(5) |
In order to take account of the specific situation of Northern Ireland, it is appropriate to adopt specific rules relating to the placing on the market in Northern Ireland of medicinal products for human use. |
(6) |
It is appropriate to clarify that the provisions of Union law listed in Annex 2 to the Protocol should apply in respect of medicinal products for human use intended to be placed on the market in Northern Ireland, unless specific rules are laid down in this Regulation. Where specific rules of this Regulation apply, and there is an inconsistency between those specific rules of this Regulation and the provisions of Union law listed in Annex 2 to the Protocol, those specific rules of this Regulation should take precedence. |
(7) |
Furthermore, it is important to ensure that the application of the specific rules laid down in this Regulation does not lead to an increased risk to public health in the internal market. |
(8) |
The specific rules should include a prohibition against displaying the safety features referred to in Directive 2001/83/EC on the outer packaging or, where there is no outer packaging, on the immediate packaging of medicinal products for human use intended to be placed on the market in Northern Ireland and a prohibition against placing on the market in Northern Ireland new and innovative medicinal products that have been granted a marketing authorisation in accordance with Regulation (EC) No 726/2004. Furthermore, the specific rules should include certain labelling requirements for medicinal products for... |
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