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Document 22022D2014
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]
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]
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]
OJ L 279, 27.10.2022, p. 14–14
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
Date of entry into force unknown (pending notification) or not yet in force.
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27.10.2022 |
EN |
Official Journal of the European Union |
L 279/14 |
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:
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(1) |
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 (1) is to be incorporated into the EEA Agreement. |
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(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:
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‘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
(*) No constitutional requirements indicated.