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Document 22016D0503
Decision of the EEA Joint Committee No 15/2015 of 25 February 2015 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2016/503]
Decision of the EEA Joint Committee No 15/2015 of 25 February 2015 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2016/503]
Decision of the EEA Joint Committee No 15/2015 of 25 February 2015 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2016/503]
OJ L 93, 7.4.2016, p. 26–27
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
|
7.4.2016 |
EN |
Official Journal of the European Union |
L 93/26 |
DECISION OF THE EEA JOINT COMMITTEE
No 15/2015
of 25 February 2015
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2016/503]
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 Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (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 15zp (Commission Implementing Decision 2012/707/EU) of Chapter XIII of Annex II to the EEA Agreement:
|
‘15zq. |
32012 R 0520: Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (OJ L 159, 20.6.2012, p. 5).’ |
Article 2
The text of Implementing Regulation (EU) No 520/2012 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 26 February 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, 25 February 2015.
For the EEA Joint Committee
The President
Gianluca GRIPPA
(1) OJ L 159, 20.6.2012, p. 5.
(*1) Constitutional requirements indicated.