See Full Document Text
Official Journal EN
of the European Union L series
2025/30 9.1.2025
COUNCIL DECISION (EU) 2025/30
of 17 December 2024
on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee
concerning the amendment of Annex II (Technical regulations, standards, testing and certification),
Annex X (Services in general) and Protocol 37 (containing the list provided for in Article 101) to the
EEA Agreement (Health Technology Assessment)
(Text with EEA relevance)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168 in
conjunction with Article 218(9) thereof,
Having regard to Council Regulation (EC) No 2894/94 of 28 November 1994 concerning arrangements for implementing
the Agreement on the European Economic Area (1), and in particular Article 1(3) thereof,
Having regard to the proposal from the European Commission,
Whereas:
(1) The Agreement on the European Economic Area (2) (the ‘EEA Agreement’) entered into force on 1 January 1994.
(2) Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex II
(Technical regulations, standards, testing and certification), Annex X (Services in general) and Protocol 37
(containing the list provided for in Article 101) to the EEA Agreement.
(3) Regulation (EU) 2021/2282 of the European Parliament and of the Council (3) should be incorporated into the EEA
Agreement.
(4) Annex II (Technical regulations, standards, testing and certification), Annex X (Services in general) and Protocol 37
(containing the list provided for in Article 101) to the EEA Agreement should therefore be amended accordingly.
(5) The position of the Union within the EEA Joint Committee should therefore be based on the attached draft decision,
HAS ADOPTED THIS DECISION:
Article 1
The position to be adopted on behalf of the Union within the EEA Joint Committee on the proposed amendment of
Annex II (Technical regulations, standards, testing and certification), Annex X (Services in general) and Protocol 37
(containing the list provided for in Article 101) to the EEA Agreement, shall be based on the draft decision of the EEA Joint
Committee attached to this Decision.
Article 2
This Decision shall enter into force on the date of its adoption.
Done at Brussels, 17 December 2024.
For the Council
The President
BÓKA J.
(1) OJ L 305, 30.11.1994, p. 6.
(2) OJ L 1, 3.1.1994, p. 3.
(3) Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment
and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, p. 1).
ELI: http://data.europa.eu/eli/dec/2025/30/oj 1/3EN
OJ L, 9.1.2025
DRAFT
DECISION OF THE EEA JOINT COMMITTEE No …
of …
amending Annex II (Technical regulations, standards, testing and certification), Annex X (Services in
general) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement
THE EEA JOINT COMMITTEE,
Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98
thereof,
Whereas:
(1) Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health
technology assessment and amending Directive 2011/24/EU (1) is to be incorporated into the EEA Agreement.
(2) Annexes II and X and Protocol 37 to the EEA Agreement should therefore be amended accordingly,
HAS ADOPTED THIS DECISION:
Article 1
Annex II to the EEA Agreement shall be amended as follows:
1. The following is inserted after the seventeenth paragraph of the introductory part of Chapter XIII:
‘The EFTA States shall be fully associated with the work of the Member State Coordination Group on Health Technology
Assessment, including its subgroups, as established by Article 3 of Regulation (EU) 2021/2282 of the European
Parliament and of the Council and shall have the same rights and obligations within it as the EU Member States.
By way of derogation from the previous paragraph, the members designated by the EFTA States shall not be entitled to
participate in votes. However, where voting takes place, positions of the members designated by the EFTA States shall be
recorded separately upon their request.
Pursuant to Article 12(2) of Regulation (EU) 2021/2282, where consensus cannot be reached, divergent scientific
opinions by the EFTA States, including the scientific grounds on which those opinions are based, shall be incorporated in
the reports.’
2. The following is inserted after point 22k (Commission Implementing Regulation (EU) 2022/1255) of Chapter XIII:
‘23. 32021 R 2282: Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021
on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, p. 1).
The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:
Paragraph 4(a) of Protocol 1 to this Agreement shall not apply to Article 3.’
3. The following is inserted in the introductory part of Chapter XXX:
‘The EFTA States shall be fully associated with the work of the Member State Coordination Group on Health Technology
Assessment, including its subgroups, as established by Article 3 of Regulation (EU) 2021/2282 of the European
Parliament and of the Council and shall have the same rights and obligations within it as the EU Member States.
By way of derogation from the previous paragraph, the members designated by the EFTA States shall not be entitled to
participate in votes. However, where voting takes place, the positions of the members designated by the EFTA States shall
be recorded separately upon their request.
(1) OJ L 458, 22.12.2021, p. 1.
2/3 ELI: http://data.europa.eu/eli/dec/2025/30/ojEN
OJ L, 9.1.2025
Pursuant to Article 12(2) of Regulation (EU) 2021/2282, where a consensus cannot be reached, divergent scientific
opinions by the EFTA States, including the scientific grounds on which those opinions are based, shall be incorporated in
the reports.’
4. The following point is inserted after point 15 (Commission Implementing Regulation (EU) 2020/1207) of Chapter XXX:
‘16. 32021 R 2282: Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021
on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, p. 1).
The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:
Paragraph 4(a) of Protocol 1 to this Agreement shall not apply to Article 3.’
Article 2
The following is added in point 2 (Directive 2011/24/EU of the European Parliament and of the Council) of Annex X to the
EEA Agreement:
‘, as amended by:
— 32021 R 2282: Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 (OJ
L 458, 22.12.2021, p. 1).’
Article 3
The following point is inserted in Protocol 37 to the EEA Agreement:
‘50. Member State Coordination Group on Health Technology Assessment (Regulation (EU) 2021/2282 of the European
Parliament and of the Council).’
Article 4
The text of Regulation (EU) 2021/2282 in the Icelandic and Norwegian languages, to be published in the EEA Supplement
to the Official Journal of the European Union, shall be authentic.
Article 5
This Decision shall enter into force on …, provided that all the notifications under Article 103(1) of the EEA Agreement
have been made (*).
Article 6
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European
Union.
Done at Brussels, …
For the EEA Joint Committee The Secretaries
The President To the EEA Joint Committee
(*) [No constitutional requirements indicated.] [Constitutional requirements indicated.]
ELI: http://data.europa.eu/eli/dec/2025/30/oj 3/3