# C_2012307EN.01002401.xml

| 11.10.2012 | EN | Official Journal of the European Union | C 307/24 |
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11.10.2012

EN

Official Journal of the European Union

C 307/24

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JUDGMENT OF THE COURT

of 30 March 2012

in Case E-7/11

Grund, elli- og hjúkrunarheimili v the Icelandic Medicines Agency (Lyfjastofnun)

(Directive 2001/83/EC — Free movement of goods — Pharmaceuticals — Parallel import — Control reports — Protection of public health — Justification — Language requirements for labelling and package leaflets)

2012/C 307/10

In Case E-7/11 Grund, elli- og hjúkrunarheimili v the Icelandic Medicines Agency (Lyfjastofnun) — REQUEST to the Court under Article 34 of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice by Héraðsdómur Reykjavíkur (Reykjavik District Court) concerning the interpretation of Directive 2001/83/EC and Articles 11 and 13 of the EEA Agreement, the Court, composed of Carl Baudenbacher, President, Per Christiansen (Judge-Rapporteur) and Páll Hreinsson, Judges, gave judgment on 30 March 2012, the operative part of which is as follows:

| 1. | The national authorities may make importation by a health care institution, such as the Plaintiff, for use by the people in the care of the institution, of medicinal products from Norway which have been granted national marketing authorisation in Norway, and which are identical or essentially similar to products which have national marketing authorisation in Iceland, subject to a parallel import licence.
  Such a licence must be issued under a procedure limited to controlling that the medicinal products in question have a valid marketing authorisation in the EEA State of export, and that the product is identical or essentially similar to products having marketing authorisation in the EEA State of importation.
  In this context, the national authorities may not require parallel importers, such as the Plaintiff, to submit manufacturing control reports. Such a practice cannot be justified under Article 13 EEA. |
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1.

The national authorities may make importation by a health care institution, such as the Plaintiff, for use by the people in the care of the institution, of medicinal products from Norway which have been granted national marketing authorisation in Norway, and which are identical or essentially similar to products which have national marketing authorisation in Iceland, subject to a parallel import licence.

Such a licence must be issued under a procedure limited to controlling that the medicinal products in question have a valid marketing authorisation in the EEA State of export, and that the product is identical or essentially similar to products having marketing authorisation in the EEA State of importation.

In this context, the national authorities may not require parallel importers, such as the Plaintiff, to submit manufacturing control reports. Such a practice cannot be justified under Article 13 EEA.

| 2. | When a medicinal product is not intended to be delivered directly to the patient, the competent authorities’ right to grant exemptions under Article 63(3) of Directive 2001/83/EC is limited by the general principles of EEA law. The discretion must not be exercised in a disproportionate, arbitrary or abusive, in particular protectionist, manner. |
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2.

When a medicinal product is not intended to be delivered directly to the patient, the competent authorities’ right to grant exemptions under Article 63(3) of Directive 2001/83/EC is limited by the general principles of EEA law. The discretion must not be exercised in a disproportionate, arbitrary or abusive, in particular protectionist, manner.

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