Date: 2026-05-21Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 22/2026 of 6 February 2026 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2026/952]
**Executive Summary**
This decision, adopted on 6 February 2026, amends Annex II of the EEA Agreement to incorporate Regulation (EU) 2023/1182 and Directive (EU) 2022/642 concerning medicinal products for human use. The amendments establish specific adaptations for EFTA States and clarify the non-applicability of certain provisions. The decision is scheduled to enter into force on 7 February 2026, provided all necessary notifications under the EEA Agreement have been made.
**Key Points / Main Content**
**Incorporation of EU Legislation**
* **Directive (EU) 2022/642:** This directive, which concerns derogations for certain medicinal products made available in the UK (Northern Ireland), Cyprus, Ireland, and Malta, is formally incorporated into Annex II of the EEA Agreement.
* **Regulation (EU) 2023/1182:** Specific rules regarding medicinal products intended for the Northern Ireland market and amendments to Directive 2001/83/EC are now included in the agreement.
**Adaptations and Exemptions for EFTA States**
* **Directive 2001/83/EC Limitations:** The decision specifies that Article 5a, Article 8(2a), Article 8(2b), the second subparagraph of Article 20, and Article 126c of Directive 2001/83/EC shall not apply to EFTA States.
* **Regulation (EU) 2023/1182 Limitations:** For the purposes of the EEA Agreement, Article 1(3), Articles 3–6, and Articles 8–12 of Regulation (EU) 2023/1182 are excluded from application in EFTA States.
**Administrative and Legal Provisions**
* **Authentic Texts:** The texts of the incorporated Regulation and Directive will be published in Icelandic and Norwegian, with these versions being considered authentic.
* **Force and Publication:** The decision enters into force on 7 February 2026, following required notifications, and will be published in the EEA Section of and the EEA Supplement to the Official Journal of the European Union.
**Impact Analysis**
**EFTA States (Iceland, Liechtenstein, and Norway)**
**Impact**
EFTA States are affected by the updating of technical regulations regarding medicinal products. However, they are granted specific exemptions from various articles of the incorporated EU legislation, meaning those particular rules do not apply within their jurisdictions.
**Action Required**
EFTA States must ensure all notifications required under Article 103(1) of the EEA Agreement are completed to facilitate the entry into force of the decision.
**EEA Joint Committee**
**Impact**
The Committee is responsible for maintaining the consistency of the EEA Agreement by incorporating relevant EU law.
**Action Required**
The Committee must oversee the publication of the decision and ensure the Icelandic and Norwegian translations of the incorporated acts are published in the EEA Supplement.
Key Entities Referenced
EEA Agreement: The fundamental treaty establishing the European Economic Area, the technical annexes of which are amended by this decision to incorporate new EU medicinal product rules.
Regulation (EU) 2023/1182: Legislation establishing specific rules for medicinal products for human use intended for the market in Northern Ireland.
Directive (EU) 2022/642: Amending act providing derogations for medicinal products made available in the United Kingdom (Northern Ireland), Cyprus, Ireland, and Malta.
Directive 2001/83/EC: The Community code relating to medicinal products for human use, which serves as the primary legal framework modified by the incorporated acts.
EEA Joint Committee: The administrative body responsible for the management of the EEA Agreement and the issuance of this decision.
Official Journal EN
of the European Union L series
2026/952 21.5.2026
DECISION OF THE EEA JOINT COMMITTEENo 22/2026
of 6 February 2026
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2026/952]
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) 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/EC(1)is to be incorporated into the EEA Agreement.
(2) Directive (EU) 2022/642 of the European Parliament and of the Council of 12 April 2022 amending
Directives 2001/20/EC and 2001/83/EC as regards derogations from certain obligations concerning certain
medicinal products for human use made available in the United Kingdom in respect of Northern Ireland and in
Cyprus, Ireland and Malta(2)is to be incorporated into the EEA Agreement.
(3) Annex II to the EEA Agreement should therefore be amended accordingly,
HAS ADOPTED THIS DECISION:
Article 1
Chapter XIII of Annex II to the EEA Agreement is amended as follows:
1. Point 15q (Directive 2001/83/EC of the European Parliament and of the Council) is amended as follows:
(i) the following indents are added:
‘— 32022 L 0642: Directive (EU) 2022/642 of the European Parliament and of the Council of 12 April
2022 (OJ L 118, 20.4.2022, p. 4),
— 32023 R 1182: Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June
2023 (OJ L 157, 20.6.2023, p. 1).’;
(ii) adaptations (b) to (d) shall be renumbered as adaptations (c) to (e);
(iii) the following adaptation is inserted after adaptation (a):
‘(b) Article 5a, Article 8(2a), Article 8(2b), second subparagraph of Article 20 and Article 126c shall not
apply to the EFTA States.’.
2. The following is inserted after point 23b (Commission Implementing Regulation (EU) 2025/117):
‘24. 32023 R 1182: 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/EC (OJ L 157, 20.6.2023, p. 1).
The Regulation shall, for the purposes of this Agreement, be read with the following adaptation:
Article 1(3), Articles 3–6 and Articles 8–12 shall not apply to the EFTA States.’
(1) OJ L 157, 20.6.2023, p. 1.
(2) OJ L 118, 20.4.2022, p. 4.
ELI: http://data.europa.eu/eli/dec/2026/952/oj 1/2EN
OJ L, 21.5.2026
Article 2
The texts of Regulation (EU) 2023/1182 and Directive (EU) 2022/642 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 7 February 2026, provided that all the notifications under Article 103(1) of the EEA
Agreement have been made(*).
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, 6 February 2026.
For the EEA Joint Committee
The President
Nicolas VON LINGEN
(*) No constitutional requirements indicated.
2/2 ELI: http://data.europa.eu/eli/dec/2026/952/oj