Source: EURLEX
Language: en
Format: md

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| 23.9.2021 | EN | Official Journal of the European Union | L 337/30 |

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DECISION OF THE EEA JOINT COMMITTEE No 238/2018

of 5 December 2018

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2021/1505]

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 Regulation (EU) 2018/781 of 29 May 2018 amending Regulation (EC) No 847/2000 as regards the definition of the concept ‘similar medicinal product’ [(1)](#ntr1-L_2021337EN.01003001-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 is added in point 15n (Commission Regulation (EC) No 847/2000) of Chapter XIII of Annex II to the EEA Agreement:

‘, as amended by:

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| — | 32018 R 0781: Commission Regulation (EU) 2018/781 of 29 May 2018 ([OJ L 132, 30.5.2018, p. 1](./../../../legal-content/EN/AUTO/?uri=OJ:L:2018:132:TOC)).’ |

Article 2

The text of Commission Regulation (EU) 2018/781 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 6 December 2018, provided that all the notifications under Article 103(1) of the EEA Agreement have been made [(\*)](#ntr*-L_2021337EN.01003001-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, 5 December 2018.

For the EEA Joint Committee

The President

Oda Helen SLETNES

The Secretaries

To the EEA Joint Committee

Hege M. HOFF

Mikołaj KARŁOWSKI

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