Date: 2022-06-30Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 28/2022 of 4 February 2022 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/1076]
**Summary:**
EEA Joint Committee Decision No. 28/2022, adopted on February 4, 2022, amends Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement. The amendment incorporates Commission Decision (EU) 2021/1240 of July 13, 2021, into the EEA Agreement. This Commission Decision concerns the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements outlined in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council. The text of Decision (EU) 2021/1240 will be published in Icelandic and Norwegian in the EEA Supplement to the Official Journal of the European Union and will be considered authentic. This Decision entered into force on February 5, 2022, following the completion of notifications under Article 103(1) of the EEA Agreement. The decision will be published in the EEA Section of, and 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, governing trade and economic relations between the EU and certain other European countries.
Annex II to the EEA Agreement: A section of the EEA Agreement pertaining to technical regulations, standards, testing, and certification.
Commission Decision EU 2021/1240: A decision by the European Commission regarding the compliance of the EU portal and EU database for clinical trials of medicinal products for human use.
Regulation EU No 536/2014: A regulation of the European Parliament and of the Council concerning clinical trials on medicinal products for human use.
European Parliament: One of the legislative branch of the European Union
Council of the European Union: The other legislative branch of the European Union
Brussels: The city where the decision was made.
30.6.2022 EN Official Journal of the European Union L 175/45
DECISION OF THE EEA JOINT COMMITTEE No 28/2022
of 4 February 2022
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2022/1076]
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 Decision (EU) 2021/1240 of 13 July 2021on the compliance of the EU portal and the EU database for
clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation
(EU) No 536/2014 of the European Parliament and of the Council(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
The following point is inserted after point 18a (Commission Delegated Regulation (EU) 2017/1569) of Chapter XIII of
Annex II to the EEA Agreement:
‘18b. 32021 D 1240: Commission Decision (EU) 2021/1240 of 13 July 2021on the compliance of the EU portal and the
EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2)
of Regulation (EU) No 536/2014 of the European Parliament and of the Council (OJ L 275, 31.7.2021, p. 1).’
Article 2
The text of Decision (EU) 2021/1240 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 5 February 2022, 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, 4 February 2022.
For the EEA Joint Committee
The President
Nicolas VON LINGEN
(1) OJ L 275, 31.7.2021, p. 1.
(*) No constitutional requirements indicated.