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Document E2015J0033
Judgment of the Court of 2 August 2016 in Case E-33/15 — EFTA Surveillance Authority v Iceland (Failure by an EEA/EFTA State to fulfil its obligations — Failure to implement Directive 2012/26/EU amending Directive 2001/83/EC as regards pharmacovigilance)
Judgment of the Court of 2 August 2016 in Case E-33/15 — EFTA Surveillance Authority v Iceland (Failure by an EEA/EFTA State to fulfil its obligations — Failure to implement Directive 2012/26/EU amending Directive 2001/83/EC as regards pharmacovigilance)
Judgment of the Court of 2 August 2016 in Case E-33/15 — EFTA Surveillance Authority v Iceland (Failure by an EEA/EFTA State to fulfil its obligations — Failure to implement Directive 2012/26/EU amending Directive 2001/83/EC as regards pharmacovigilance)
OJ C 120, 13.4.2017, p. 22–22
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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13.4.2017 |
EN |
Official Journal of the European Union |
C 120/22 |
JUDGMENT OF THE COURT
of 2 August 2016
in Case E-33/15
EFTA Surveillance Authority v Iceland
(Failure by an EEA/EFTA State to fulfil its obligations — Failure to implement Directive 2012/26/EU amending Directive 2001/83/EC as regards pharmacovigilance)
(2017/C 120/10)
In Case E-33/15, EFTA Surveillance Authority v Iceland — APPLICATION for a declaration that Iceland has failed to fulfil its obligations under the Act referred to at point 15q of Chapter XIII of Annex II to the Agreement on the European Economic Area (Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance) as adapted to the Agreement under Protocol 1 thereto, and under Article 7 of the Agreement, by failing to adopt the measures necessary to implement the Act within the time prescribed, or in any event by failing to inform the EFTA Surveillance Authority thereof, the Court, composed of Carl Baudenbacher, President (Judge-Rapporteur), Per Christiansen and Páll Hreinsson, Judges, gave judgment on 2 August 2016, the operative part of which is as follows:
The Court hereby:
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1. |
Declares that Iceland has failed to fulfil its obligations under the Act referred to at point 15q of Chapter XIII of Annex II to the Agreement on the European Economic Area (Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance) as adapted to the Agreement under its Protocol 1, and under Article 7 of the Agreement, by failing to adopt the measures necessary to implement the Act within the time prescribed. |
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2. |
Orders Iceland to bear the costs of the proceedings. |