Date: 2022-10-27Category: Not ApplicableState: Union GovernmentCountry: Europe
Decision of the EEA Joint Committee No 116/2019 of 8 May 2019 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/2014]
**Policy Summary:**
This decision of the EEA Joint Committee, numbered 116/2019 and dated 8 May 2019, amends Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement. The amendment incorporates Commission Delegated Regulation (EU) 2016/161 into the EEA Agreement. Regulation (EU) 2016/161, dated 2 October 2015, supplements Directive 2001/83/EC of the European Parliament and of the Council. It establishes detailed rules for safety features on the packaging of medicinal products for human use. The authentic Icelandic and Norwegian language texts of Delegated Regulation (EU) 2016/161 will be published in the EEA Supplement to the Official Journal of the European Union. This decision took effect on 1 June 2019, contingent upon completion of all notifications required under Article 103(1) of the EEA Agreement. The decision was 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.
Annex II to the EEA Agreement: A section of the EEA Agreement pertaining to technical regulations, standards, testing, and certification.
Commission Delegated Regulation EU 2016/161: A European Union regulation supplementing Directive 2001/83/EC regarding safety features on medicinal product packaging.
Directive 2001/83/EC: A directive of the European Parliament and of the Council concerning the Community code relating to medicinal products for human use.
European Parliament: One of the legislative branches of the European Union.
Council of the European Union: A legislative body of the European Union comprising government ministers from each member state.
Brussels: The location where the decision was made.
L 279/14 EN Official Journal of the European Union 27.10.2022
DECISION OF THE EEA JOINT COMMITTEE No 116/2019
of 8 May 2019
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
[2022/2014]
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) 2016/161 of 2 October 2015supplementing Directive 2001/83/EC of the
European Parliament and of the Council by laying down detailed rules for the safety features appearing on the
packaging of medicinal products for human use(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 15qe (Commission Directive (EU) 2017/1572) of Chapter XIII of Annex II to the
EEA Agreement:
‘15qf. 32016 R 0161: Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive
2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features
appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).’
Article 2
The text of Delegated Regulation (EU) 2016/161 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 1 June 2019, 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, 8 May 2019.
For the EEA Joint Committee
The President
Claude MAERTEN
(1) OJ L 32, 9.2.2016, p. 1.
(*) No constitutional requirements indicated.