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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 14 CELEX: 32023R1182 Entry into force and application
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2025, provided that the United Kingdom has provided the written guarantees referred to in Article 8 and that the Commission has published prior to that date the notice referred to in the fifth paragraph of this Article.
In the event that those written guarantees are provided earlier than 1 January 2025 or later than that date, this Regulation shall apply from the first day of the month following the month during which the United Kingdom provides those written guarantees.
Within one month of reception of those written guarantees, the Commission shall provide a report to the European Parliament and to the Council with its assessment of those written guarantees.
The Commission shall publish a notice in the Official Journal of the European Union indicating the date from which this Regulation applies. |