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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 9 CELEX: 32023R1182 Suspension of the specific rules laid down in Articles 3, 4 and 5
1. The Commission shall continuously monitor the application by the United Kingdom of the specific rules laid down in Articles 3, 4 and 5. 2. Where there is evidence that the United Kingdom is not taking appropriate measures to address serious or repeated infringements of the specific rules laid down in Articles 3, 4 and 5, the Commission shall inform the United Kingdom by means of written notification. For a period of three months from the date of the written notification referred to in the first subparagraph, the Commission shall enter into consultations with the United Kingdom with a view to remedying the situation giving rise to that written notification. In justified cases, the Commission may extend that period by a further three months. |
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 9 CELEX: 32023R1182 3. If the situation giving rise to the written notification referred to in paragraph 2, first subparagraph, of this Article is not remedied within the period referred to in paragraph 2, second subparagraph, of this Article, the Commission is empowered to adopt a delegated act in accordance with Articles 10 and 11 to supplement this Regulation by specifying the specific rules among those referred to in paragraph 1 of this Article whose application is to be temporarily or permanently suspended. 4. Where a delegated act has been adopted in accordance with paragraph 3 of this Article, the specific rules of Articles 3, 4 and 5 as specified in that delegated act shall cease to apply on the first day of the month following the entry into force of that delegated act. 5. Where the situation giving rise to the adoption of the delegated act in accordance with paragraph 3 of this Article has been remedied, the Commission shall adopt a delegated act in accordance with Articles 10 and 11 to supplement this Regulation by specifying those suspended specific rules of Articles 3, 4 and 5 that are to apply again. |
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 9 CELEX: 32023R1182 6. Where a delegated act has been adopted in accordance with paragraph 5 of this Article, the specific rules of Articles 3, 4 and 5 as specified in that delegated act shall apply again on the first day of the month following the entry into force of that delegated act. |