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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 12 CELEX: 32023R1182 Transitional provisions for safeguard requirements
Medicinal products that have been lawfully placed on the market in Northern Ireland before the date of application referred to in Article 14, and that are not repackaged or relabelled after that date, may be further made available on the market in Northern Ireland until their expiry date without being required to comply with the specific rules laid down in Articles 3, 4 and 5. |