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/ECText with EEA relevance.

Article 5a of Directive 2001/83/EC is deleted with effect from the date of application referred to in Article 14 of this Regulation.

Article 14

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 14 June 2023.

For the European Parliament

The President

R. Metsola

For the Council

The President

J. Roswall