1Regulation (EU) 2025/2645 of the European Parliament and of the Council of 16 December 2025 on compulsory licensing for crisis management and amending Regulation (EC) No 816/2006 (Text with EEA relevance)

32025R2645

Den Europæiske UnionForordning2025

European Union

§ Article 2

Article 2(4) shall apply mutatis mutandis.

Member States shall inform the Commission of the national authority tasked with providing the information under paragraph 1. The Commission shall publish the list of those national authorities on its website.

Article 23

Committee procedure

The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.

Article 24

Amendments to Regulation (EC) No 816/2006

Regulation (EC) No 816/2006 is amended as follows:

(1) the following article is inserted:

Article 18a

Union compulsory licence

By way of derogation from Article 1, second subparagraph, from Article 2, point (4), and from Article 3, the Commission may grant a compulsory licence applicable to the whole of the Union where the activities of manufacture and sale for export are spread across different Member States and would therefore require compulsory licences for the same product in more than one Member State.

Any person may submit an application for a Union compulsory licence referred to in paragraph 1 of this Article. By way of derogation from Article 6(1) and (2), that application shall be submitted to the Commission. The application shall fulfil the requirements laid down in Article 6(3), points (a) to (f), and shall specify the Member States in which the activities of manufacture and sale for export of the product to be covered by the Union compulsory licence are to be carried out.

Articles 7, 8, 9 and 12 shall apply mutatis mutandis.

The Union compulsory licence referred to in paragraph 1 of this Article shall be subject to the conditions set out in Article 10 and shall specify that it is applicable to the whole of the Union.

The Commission shall, by means of an implementing act:

(a) grant a Union compulsory licence referred to in paragraph 1;

(b) reject an application for a Union compulsory licence submitted pursuant to paragraph 2;

In cases referred to in the first subparagraph, point (b), of this paragraph, Article 11 shall apply mutatis mutandis.

In cases referred to in the first subparagraph, point (c), of this paragraph, Article 5, point (c), and Article 16 shall apply mutatis mutandis.

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 18b(2).

On duly justified imperative grounds of urgency relating to the impact of the public health problems to be addressed, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 18b(3).

;

(2) the following article is inserted:

Article 18b

Committee procedure

The Commission shall be assisted by a committee (the Compulsory Licensing Committee). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.

;

(3) the following article is inserted:

Article 18c

Applicability to and in the United Kingdom in respect of Northern Ireland

The procedure for granting a Union compulsory licence under Article 18a, and a Union compulsory licence granted under that Article, shall not apply to and in the United Kingdom in respect of Northern Ireland. The United Kingdom in respect of Northern Ireland shall ensure that the products manufactured under such a licence are not imported into the Union or Northern Ireland in accordance with Article 13, and shall take the necessary actions to that end in accordance with Article 14..

Article 25

Evaluation

The Commission shall, by the last day of the third year following the granting of the first Union compulsory licence in accordance with Article 7, present to the European Parliament, the Council and the European Economic and Social Committee an evaluation report on the application of this Regulation.

The Commission shall regularly, and for the first time by 31 December 2027, assess whether the list in the Annex is up to date, including, in particular, in relation to semiconductors for medical equipment. It may, where appropriate, submit proposals to amend the Annex.

Every five years from 19 January 2026, the Commission shall report on the assessments carried out pursuant to the second paragraph to the European Parliament and the Council.

Article 26

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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

Done at Strasbourg, 16 December 2025.

For the European Parliament

The President

R. Metsola

For the Council

The President

M. Bjerre

Annex

ANNEX

List of Union crisis or emergency mechanisms, crisis or emergency modes and advisory bodies

Union crisis or emergency mechanismCrisis or emergency modeAdvisory body

Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU

Public health emergency at Union level formally recognised by means of a Commission implementing act

(Article 23 of Regulation (EU) 2022/2371)

Health Security Committee

(Article 4 of Regulation (EU) 2022/2371)

Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level

Emergency framework activated by means of a Council Regulation

(Article 3 of Regulation (EU) 2022/2372)

Health Crisis Board

(Article 5 of Regulation (EU) 2022/2372)

Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act)

Internal Market emergency mode activated by means of a Council implementing act

(Article 18 of Regulation (EU) 2024/2747)

Internal Market Emergency and Resilience Board

(Article 4 of Regulation (EU) 2024/2747)

Metadata

Type: Forordning
År: 2025
Ikrafttrædelsesdato: 1. januar 1970