Source: EURLEX
Language: en
Format: md

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| 27.10.2022 | EN | Official Journal of the European Union | L 279/14 |

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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)](#ntr1-L_2022279EN.01001401-E0001) 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](./../../../legal-content/EN/AUTO/?uri=OJ:L:2016:032:TOC)).’ |

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 [(\*)](#ntr*-L_2022279EN.01001401-E0002).

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

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