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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)

article  1

CELEX:  32023R1182

Subject matter and scope
1. This Regulation lays down specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland in accordance with Article 6 of Directive 2001/83/EC.
2. This Regulation also lays down rules regarding the suspension of the application of the specific rules laid down in this Regulation.
3. The provisions of Union law listed in Annex 2 to the Protocol on Ireland/Northern Ireland (the ‘Protocol’) shall apply in respect of the placing on the market in Northern Ireland of medicinal products as referred to in paragraph 1 of this Article, unless specific rules are laid down in this Regulation.