Date: 2023-11-30Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 147/2023 of 13 June 2023 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2023/2544]
**Summary:**
EEA Joint Committee Decision No. 147/2023, dated June 13, 2023, amends Annex II (Technical regulations, standards, testing and certification) to the Agreement on the European Economic Area (EEA). The decision incorporates two EU acts into the EEA Agreement: Commission Delegated Regulation (EU) 2022/315 of December 17, 2021, which concerns a derogation for wholesalers from decommissioning unique identifiers on medicinal products exported to the United Kingdom, and Commission Implementing Decision (EU) 2023/172 of January 24, 2023, which adds Canada to the list of third countries recognized under Implementing Decision 2012/715/EU. Article 1 details the specific amendments to Chapter XIII of Annex II, adding references to the aforementioned regulations. Article 2 stipulates that the Icelandic and Norwegian language versions of the incorporated regulations will be published in the EEA Supplement to the Official Journal of the European Union and shall be authentic. The decision entered into force on June 14, 2023, contingent upon completion of notifications required under Article 103(1) of the EEA Agreement. The decision was published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.
Key Entities Referenced
EEA Joint Committee: The decision-making body responsible for amending the EEA Agreement.
EEA Agreement: The Agreement on the European Economic Area.
Commission Delegated Regulation EU 2022/315: A regulation amending Delegated Regulation EU 2016/161 regarding the decommissioning of unique identifiers for medicinal products exported to the United Kingdom.
Commission Implementing Decision EU 2023/172: A decision amending Implementing Decision 2012/715/EU regarding the inclusion of Canada in the list of third countries.
United Kingdom: A country mentioned in the context of medicinal product exports.
Canada: A country included in the list of third countries according to Implementing Decision EU 2023/172.
Annex II to the EEA Agreement: Technical regulations, standards, testing and certification to the EEA Agreement.
Brussels: The location where the decision was made.
Official Journal EN
of the European Union L series
2023/2544 30.11.2023
DECISION OF THE EEA JOINT COMMITTEE No 147/2023
of 13 June 2023
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2023/2544]
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 Delegated Regulation (EU) 2022/315 of 17 December 2021 amending Delegated Regulation
(EU) 2016/161 as regards the derogation from the obligation of wholesalers to decommission the unique identifier
of medicinal products exported to the United Kingdom(1)is to be incorporated into the EEA Agreement.
(2) Commission Implementing Decision (EU) 2023/172 of 24 January 2023 amending Implementing
Decision 2012/715/EU as regards the inclusion of Canada in the list of third countries established by that
Decision(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 shall be amended as follows:
1. The following indent is added in point 15qb (Commission Implementing Decision 2012/715/EU):
‘- 32023 D 0172: Commission Implementing Decision (EU) 2023/172 of 24 January 2023 (OJ L 24, 26.1.2023,
p. 37).’
2. The following indent is added in point 15qf (Commission Delegated Regulation (EU) 2016/161):
‘- 32022 R 0315: Commission Delegated Regulation (EU) 2022/315 of 17 December 2021 (OJ L 55, 28.2.2022,
p. 33).’
Article 2
The texts of Delegated Regulation (EU) 2022/315 and Implementing Decision (EU) 2023/172 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 14 June 2023, 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.
(1) OJ L 55, 28.2.2022, p. 33.
(2) OJ L 24, 26.1.2023, p. 37.
* No constitutional requirements indicated.
ELI: http://data.europa.eu/eli/dec/2023/2544/oj 1/2EN
OJ L, 30.11.2023
Done at Brussels, 13 June 2023.
For the EEA Joint Committee
The President
Nicolas VON LINGEN
2/2 ELI: http://data.europa.eu/eli/dec/2023/2544/oj