# C_2015410EN.01000701.xml

| 10.12.2015 | EN | Official Journal of the European Union | C 410/7 |
| --- | --- | --- | --- |

10.12.2015

EN

Official Journal of the European Union

C 410/7

---

Action brought on 17 August 2015 by the EFTA Surveillance Authority against the Principality of Liechtenstein

(Case E-22/15)

(2015/C 410/06)

An action against the Principality of Liechtenstein was brought before the EFTA Court on 17 August 2015 by the EFTA Surveillance Authority, represented by Markus Schneider, Clémence Perrin and Íris Ísberg, acting as Agents of the EFTA Surveillance Authority, 35 Rue Belliard, 1040 Brussels, Belgium.

The EFTA Surveillance Authority requests the EFTA Court to:

| 1. | Declare that by failing to adopt the measures necessary to implement the Act referred to at point 15q of Chapter XIII of Annex II to the Agreement on the European Economic Area (Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of entry into the legal supply chain of falsified medicinal products and 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 by way of Protocol 1 thereto, within the time prescribed, Liechtenstein has failed to fulfil its obligations under Article 2 of the Acts and under Article 7 of the EEA Agreement. |
| --- | --- |

1.

Declare that by failing to adopt the measures necessary to implement the Act referred to at point 15q of Chapter XIII of Annex II to the Agreement on the European Economic Area (Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of entry into the legal supply chain of falsified medicinal products and 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 by way of Protocol 1 thereto, within the time prescribed, Liechtenstein has failed to fulfil its obligations under Article 2 of the Acts and under Article 7 of the EEA Agreement.

| 2. | Order Liechtenstein to bear the costs of these proceedings. |
| --- | --- |

2.

Order Liechtenstein to bear the costs of these proceedings.

Legal and factual background and pleas in law adduced in support:

Legal and factual background and pleas in law adduced in support:

| — | The application addresses the failure by the Principality of Liechtenstein to comply, no later than on 11 April 2015, with a reasoned opinion delivered by the EFTA Surveillance Authority on 11 February 2015 regarding that State’s failure to implement into its national legal order Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of entry into the legal supply chain of falsified medicinal products,

  and

  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 referred to at point 15q of Chapter XIII of Annex II to the Agreement on the European Economic Area, and as adapted to that Agreement by way of Protocol 1 thereto (‘the Act’). |
| --- | --- |

—

The application addresses the failure by the Principality of Liechtenstein to comply, no later than on 11 April 2015, with a reasoned opinion delivered by the EFTA Surveillance Authority on 11 February 2015 regarding that State’s failure to implement into its national legal order Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of entry into the legal supply chain of falsified medicinal products,

Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of entry into the legal supply chain of falsified medicinal products,

and

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 referred to at point 15q of Chapter XIII of Annex II to the Agreement on the European Economic Area, and as adapted to that Agreement by way of Protocol 1 thereto (‘the Act’).

Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance

| — | The EFTA Surveillance Authority submits that Liechtenstein has failed to fulfil its obligations under Article 2 of the Acts and under Article 7 of the EEA Agreement by failing to adopt the measures necessary to implement the Acts within the time prescribed. |
| --- | --- |

—

The EFTA Surveillance Authority submits that Liechtenstein has failed to fulfil its obligations under Article 2 of the Acts and under Article 7 of the EEA Agreement by failing to adopt the measures necessary to implement the Acts within the time prescribed.

---