DECISION OF THE EEA JOINT COMMITTEE

No 88/2015

of 30 April 2015

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2016/1271]

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 Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (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 point is inserted after point 15qc (Commission Delegated Regulation (EU) No 357/2014) of Chapter XIII of Annex II to the EEA Agreement:

‘15qd.

32014 R 1252: Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (OJ L 337, 25.11.2014, p. 1).’

Article 2

The text of Delegated Regulation (EU) No 1252/2014 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 May 2015, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*1).

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, 30 April 2015.

For the EEA Joint Committee

The President

Gianluca GRIPPA

(1) OJ L 337, 25.11.2014, p. 1.

(*1) No constitutional requirements indicated.