Case C-114/15: Judgment of the Court (Fourth Chamber) of 27 October 2016 (request for a preliminary ruling from the Cour d’appel de Pau — France) — Criminal proceedings against Association des utilisateurs et distributeurs de l’agrochimie européenne (Audace) and Others (Reference for a preliminary ruling — Free movement of goods — Articles 34 and 36 TFEU — Quantitative restrictions — Parallel imports of veterinary medicinal products — Directive 2001/82/EC — Article 65 — National system of prior authorisation — Livestock farmers excluded from simplified marketing authorisation procedure — Obligation to hold a wholesale trading authorisation — Obligation to have an establishment within the Member State of import — Pharmacovigilance obligations)
Date: 2016-10-27
Institutions: Court of Justice
Subjects: branch, farmer, free movement of goods, import (EU), market approval, national law, pharmaceutical legislation, quantitative restriction, veterinary drug, wholesale trade








C_2017006EN.01001202.xml










9.1.2017   


EN


Official Journal of the European Union


C 6/12





Judgment of the Court (Fourth Chamber) of 27 October 2016 (request for a preliminary ruling from the Cour d’appel de Pau — France) — Criminal proceedings against Association des utilisateurs et distributeurs de l’agrochimie européenne (Audace) and Others
(Case C-114/15) (1)

((Reference for a preliminary ruling - Free movement of goods - Articles 34 and 36 TFEU - Quantitative restrictions - Parallel imports of veterinary medicinal products - Directive 2001/82/EC - Article 65 - National system of prior authorisation - Livestock farmers excluded from simplified marketing authorisation procedure - Obligation to hold a wholesale trading authorisation - Obligation to have an establishment within the Member State of import - Pharmacovigilance obligations))
(2017/C 006/14)
Language of the case: French

Referring court

Cour d’appel de Pau

Parties in the main proceedings

Association des utilisateurs et distributeurs de l’agrochimie européenne (Audace), Association des éleveurs solidaires, Cruzalebes EARL, Des deux rivières EARL, Mounacq EARL, Soulard Max EARL, Francisco Xavier Erneta Azanza, Amestoya GAEC, La Vinardière GAEC reconnu, Lagunarte GAEC, André Jacques Iribarren, Ramuntcho Iribarren, Phyteron 2000 SAS, Cataloune SCL

intervening party: Conseil national de l’Ordre des vétérinaires, formerly Conseil supérieur de l’Ordre des vétérinaires, Syndicat national des vétérinaires d’exercice libéral, Administration des douanes et des droits indirects

Operative part of the judgment







1.


Articles 34 and 36 TFEU must be interpreted as precluding national legislation which restricts access to parallel imports of veterinary medicinal products to wholesale distributors holding the authorisation laid down in Article 65 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 and which, consequently, excludes from access to such imports the livestock farmers wishing to import veterinary medicinal products for the needs of their own livestock farms;










2.


Articles 34 and 36 TFEU must be interpreted as not precluding national legislation which requires livestock farmers who import in parallel veterinary medicinal products for the needs of their own livestock farms to have an establishment in the Member State of destination and to fulfil all the pharmacovigilance obligations laid down in Articles 72 to 79 of Directive 2001/82, as amended by Regulation No 596/2009.






(1)  OJ C 171, 26.5.2015.