Date: 2025-11-06Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 173/2025 of 11 July 2025 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2025/2109]
**Executive Summary**
This document is a decision by the EEA Joint Committee amending Annex II to the EEA Agreement. The amendment incorporates Commission Implementing Regulation (EU) 2024/1381 regarding procedural rules for health technology assessment into the EEA Agreement. The Decision enters into force on 12 July 2025, pending notifications.
**Key Points / Main Content**
* **Amendment to Annex II:**
* Chapter XIII is amended by inserting point '23a' which refers to Regulation (EU) 2024/1381.
* Chapter XXX is amended by inserting point '17a' which refers to Regulation (EU) 2024/1381.
* **Incorporation of Regulation (EU) 2024/1381:**
* Regulation (EU) 2024/1381 concerns procedural rules for interaction, information exchange, and participation in joint clinical assessments of medicinal products for human use at the Union level.
* It also includes templates for these joint clinical assessments.
* **Authentic Text:**
* The text of Implementing Regulation (EU) 2024/1381 in Icelandic and Norwegian is to be published in the EEA Supplement to the Official Journal of the European Union.
* **Entry into Force:**
* The decision enters into force on 12 July 2025, provided all notifications under Article 103(1) of the EEA Agreement have been made.
* **Publication:**
* The Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.
**Impact Analysis**
**EEA Member States**
* **Impact:** EEA Member States are now bound by the provisions of Implementing Regulation (EU) 2024/1381, which includes health technology assessment procedures and related templates.
* **Action Required:** Ensure compliance with the procedural rules for interaction, information exchange, and participation in joint clinical assessments, and adopt and implement the templates for the clinical assessments.
**Health Technology Assessment (HTA) Bodies**
* **Impact:** HTA bodies will be impacted by the procedural rules and must adhere to them during joint clinical assessments of medicinal products.
* **Action Required:** Familiarize themselves with Implementing Regulation (EU) 2024/1381 and adjust their procedures accordingly to ensure compliance.
**Manufacturers of Medicinal Products**
* **Impact:** Manufacturers may need to adjust their processes to align with the health technology assessment procedures outlined in Regulation (EU) 2024/1381, including providing necessary data and participating in joint clinical assessments.
* **Action Required:** Review and adapt processes to comply with the requirements for data submission and participation in joint clinical assessments.
Key Entities Referenced
EEA Agreement: Agreement on the European Economic Area, central to the scope of the Decision
Commission Implementing Regulation (EU) 2024/1381: Implementing regulation on health technology assessment, whose rules are being incorporated into the EEA Agreement
Regulation (EU) 2021/2282: Regulation on health technology assessment, providing the basis for Commission Implementing Regulation (EU) 2024/1381
EEA Joint Committee: The body responsible for adopting the Decision
Official Journal EN
of the European Union L series
2025/2109 6.11.2025
DECISION OF THE EEA JOINT COMMITTEENo 173/2025
of 11 July 2025
amending Annex II (Technical regulations, standards, testing and certification) to the
EEA Agreement [2025/2109]
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) Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 laying down, pursuant to Regulation
(EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of
information on, and participation in, the preparation and update of joint clinical assessments of medicinal products
for human use at Union level, as well as templates for those joint clinical assessments(1)is to be incorporated into
the EEA Agreement.
(2) Annex II to the EEA Agreement should therefore be amended accordingly,
HAS ADOPTED THIS DECISION:
Article 1
Annex II to the EEA Agreement is amended as follows:
1. The following point is inserted after point 23 (Regulation (EU) 2021/2282 of the European Parliament and of the
Council) of Chapter XIII:
‘23a. 32024 R 1381: Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 laying down,
pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the
interaction during, exchange of information on, and participation in, the preparation and update of joint
clinical assessments of medicinal products for human use at Union level, as well as templates for those joint
clinical assessments (OJ L, 2024/1381, 24.5.2024).’
2. The following point is inserted after point 17 (Regulation (EU) 2021/2282 of the European Parliament and of the
Council) of Chapter XXX:
‘17a. 32024 R 1381: Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 laying down,
pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the
interaction during, exchange of information on, and participation in, the preparation and update of joint
clinical assessments of medicinal products for human use at Union level, as well as templates for those joint
clinical assessments (OJ L, 2024/1381, 24.5.2024).’
Article 2
The text of Implementing Regulation (EU) 2024/1381 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 3
This Decision shall enter into force on 12 July 2025, provided that all the notifications under Article 103(1) of the EEA
Agreement have been made(*).
(1) OJ L, 2024/1381, 24.5.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/1381/oj.
(*) No constitutional requirements indicated.
ELI: http://data.europa.eu/eli/dec/2025/2109/oj 1/2EN
OJ L, 6.11.2025
Article 4
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, 11 July 2025.
For the EEA Joint Committee
The President
Kristján Andri STEFÁNSSON
2/2 ELI: http://data.europa.eu/eli/dec/2025/2109/oj