Source: EURLEX
Language: en
Format: md

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| 7.7.2022 | EN | Official Journal of the European Union | L 182/41 |

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DECISION OF THE EEA JOINT COMMITTEE No 63/2022

of 18 March 2022

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2022/1131]

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 Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials [(1)](#ntr1-L_2022182EN.01004101-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 18b (Commission Decision (EU) 2021/1240) of Chapter XIII of Annex II to the EEA Agreement:

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| ‘18c. | 32022 R 0020: Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials ([OJ L 5, 10.1.2022, p. 14](./../../../legal-content/EN/AUTO/?uri=OJ:L:2022:005:TOC)).’ |

Article 2

The text of Implementing Regulation (EU) 2022/20 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 19 March 2022, provided that all the notifications under Article 103(1) of the EEA Agreement have been made [(\*)](#ntr*-L_2022182EN.01004101-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, 18 March 2022.

For the EEA Joint Committee

The President

Nicolas VON LINGEN

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