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]
THE EEA JOINT COMMITTEE,
Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,
Whereas:
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.
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:
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(**).
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.