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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 8 CELEX: 32023R1182 Written guarantees provided by the United Kingdom to the Commission
The United Kingdom shall provide the Commission with written guarantees that the placing on the market of medicinal products as referred to in Article 1(1) does not increase the risk to public health in the internal market and that such medicinal products will not be moved to a Member State, including guarantees to the effect that: (a) economic operators comply with the labelling requirements laid down in Article 5; (b) effective monitoring, enforcement and controls of the specific rules laid down in Articles 3, 4 and 5 are in place and are carried out, by means of, inter alia, inspections and audits. |