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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
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. 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.’
This Decision shall enter into force on the date of its adoption.
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 ).’
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).’
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.
This Decision shall enter into force on …, provided that all the notifications under Article 103(1) of the EEA Agreement have been made ( *1 ) .
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union .
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.