DECISION OF THE EEA JOINT COMMITTEE

No 82/2014

of 16 May 2014

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

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 Implementing Decision 2013/196/EU of 24 April 2013 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union(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 indent is added in point 15qb (Commission Implementing Decision 2012/715/EU) of Chapter XIII of Annex II to the EEA Agreement:

‘—

32013 D 0196:

Commission Implementing Decision 2013/196/EU of 24 April 2013 (

OJ L 113, 25.4.2013, p. 22

).’

Article 2

The texts of Implementing Decision 2013/196/EU 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 17 May 2014, provided that all the notifications under Article 103(1) of the EEA Agreement have been made(2).

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, 16 May 2014.

For the EEA Joint Committee

The President

Gianluca GRIPPA

(1)

OJ L 113, 25.4.2013, p. 22

(2) No constitutional requirements indicated.