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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 4 CELEX: 32023R1182 Specific rules for medicinal products as referred to in Article 1(1) of this Regulation belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004
1. A medicinal product as referred to in Article 1(1) of this Regulation belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004 that has been granted a marketing authorisation in accordance with Article 10 of that Regulation shall not be placed on the market in Northern Ireland. |
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 4 CELEX: 32023R1182 2. Notwithstanding paragraph 1 of this Article, a medicinal product as referred to in Article 1(1) of this Regulation belonging to the categories referred to in Article 3(1) and (2) of Regulation (EC) No 726/2004 may be placed on the market in Northern Ireland provided that all of the following conditions are fulfilled: (a) the competent authorities of the United Kingdom have authorised the placing on the market of the medicinal product in accordance with the law of the United Kingdom and under the terms of the authorisation granted by them; (b) the medicinal product concerned is labelled in accordance with Article 5 of this Regulation; (c) written guarantees are provided by the United Kingdom to the Commission in accordance with Article 8 of this Regulation. |