Criminal proceedings against Association des utilisateurs et distributeurs de l’agrochimie européenne (Audace) and Others.
Date: 2016-10-27
33


In that regard, it must be borne in mind that, according to the Court’s settled case-law, in the context of the cooperation between the Court and the national courts provided for in Article 267 TFEU, it is solely for the national court before which a dispute has been brought, and which must assume responsibility for the subsequent judicial decision, to determine, in the light of the particular circumstances of the case, both the need for a preliminary ruling to enable it to deliver judgment and the relevance of the questions which it submits to the Court. Consequently, where questions submitted concern the interpretation of EU law, the Court of Justice is bound, in principle, to give a ruling (judgment of 8 September 2015, Taricco and Others, C‑105/14, EU:C:2015:555, paragraph 29 and the case-law cited).
34


Accordingly, questions concerning EU law enjoy a presumption of relevance. The Court may refuse to rule on a question referred by a national court for a preliminary ruling only where it is quite obvious that the interpretation of EU law that is sought is unrelated to the actual facts of the main action or its purpose, where the problem is hypothetical, or where the Court does not have before it the factual or legal material necessary to give a useful answer to the questions submitted to it (judgment of 8 September 2015, Taricco and Others, C‑105/14, EU:C:2015:555, paragraph 30 and the case-law cited).
35


It must be borne in mind, in that regard, that, in the context of the cooperation instituted by Article 267 TFEU, the need to provide an interpretation of EU law which will be of use to the national court means that the national court is bound to observe scrupulously the requirements concerning the content of a request for a preliminary ruling, expressly set out in Article 94 of the Rules of Procedure of the Court of Justice, of which the referring court should be aware (see, to that effect, judgment of 5 July 2016, Ognyanov, C‑614/14, EU:C:2016:514, paragraphs 18 and 19 and the case-law cited).
36


It must also be emphasised in that regard that the information provided in orders for reference serves not only to enable the Court to give useful answers but also to ensure that it is possible for the Governments of the Member States and other interested parties to submit observations in accordance with Article 23 of the Statute of the Court of Justice of the European Union. It is the Court’s duty to ensure that that possibility is safeguarded, bearing in mind that, by virtue of the abovementioned provision, only the orders for reference are notified to the interested parties (see, inter alia, judgment of 1 April 1982, Holdijk and Others, 141/81 to 143/81, EU:C:1982:122, paragraph 6, and order of 3 July 2014, Talasca, C‑19/14, EU:C:2014:2049, paragraph 23).
37


In fact, given that it is the order for reference that serves as the basis for the proceedings before the Court, it is essential that the national court should give, in the order for reference itself, the factual and regulatory context of the case in the main proceedings and at least a minimum amount of explanation of the reasons for the choice of the provisions of EU law it seeks to have interpreted and on the link it establishes between those provisions and the national legislation applicable to the proceedings pending before it (see, inter alia, judgment of 21 February 2013, Mora IPR, C‑79/12, not published, EU:C:2013:98, paragraph 37, and order of 3 July 2014, Talasca, C‑19/14, EU:C:2014:2049, paragraph 20).
38


Admittedly, in view of the spirit of judicial cooperation which governs relations between national courts and the Court of Justice in the context of preliminary-ruling proceedings, the fact that the referring court did not make certain initial findings does not necessarily mean, however, that the request for a preliminary ruling is inadmissible if, in spite of those deficiencies, the Court, in the light of the information contained in the case file, considers that it is in a position to provide a useful answer to the referring court (see, to that effect, judgment of 28 January 2016, CASTA and Others, C‑50/14, EU:C:2016:56, paragraph 48 and the case-law cited, and order of 8 September 2016, Google Ireland and Google Italy, C‑322/15, EU:C:2016:672, paragraph 24).
47


It is appropriate to note, in that regard, that, in the case of veterinary medicinal products, a parallel import presupposes, first, that the medicinal product concerned is the subject of an MA in the Member State of export, issued in accordance with the provisions of Directive 2001/82, for the same target animals and, secondly, that, without being identical in all respects to a veterinary medicinal product already authorised in the Member State of import, it has at least a common origin with the latter product, that is to say, it has been manufactured by the same company or by an undertaking connected or working under licence according to the same formulation, using the same active ingredient, and, in addition, it has the same therapeutic effect (see, by analogy with human medicinal products, judgment of 16 December 1999, Rhône-Poulenc Rorer and May & Baker, C‑94/98, EU:C:1999:614, paragraph 28).
49


Secondly, it is appropriate to note that Article 5(1) of Directive 2001/82 requires no veterinary medicinal product to be placed on the market of a Member State unless an MA has been issued by the competent authorities of that Member State in accordance with that directive. Such a requirement applies even where the medicinal product concerned is already covered by an MA issued by the competent authority of another Member State, given that Directive 2001/82 requires prior authorisation to be obtained from the competent authority of each Member State in which such a medicinal product is placed on the market and used. That obligation placed on the importer of a veterinary medicinal product to obtain, prior to the placing on the market of that medicinal product in a Member State, an MA issued in accordance with Directive 2001/82 cannot, in principle, constitute a restriction on trade between the Member States prohibited by Article 34 TFEU. The same is true of the other obligations and prohibitions provided for in Directive 2001/82, such as the prohibition, laid down in Article 9 of that directive, on administering a medicinal product to animals, when its placing on the market has not first been authorised, excluding exceptions provided for in the Member State of import (see, by analogy with plant protection products, judgment of 8 November 2007, Escalier and Bonnarel, C‑260/06 and C‑261/06, EU:C:2007:659, paragraphs 24 and 26 and the case-law cited).
51


However, where a veterinary medicinal product covered by an MA granted in accordance with the provisions of Directive 2001/82 in one Member State is imported into another Member State and that import constitutes a parallel import by reference to a veterinary medicinal product already covered by an MA in the Member State of import, the provisions of that directive on the procedure for the grant of an MA do not apply. The authorisation system for parallel imports must nevertheless be examined in the light of the provisions of the FEU Treaty on the free movement of goods (see, by analogy with pharmaceutical products, judgment of 12 November 1996, Smith & Nephew and Primecrown, C‑201/94, EU:C:1996:432, paragraph 21, and as regards plant protection products, judgment of 8 November 2007, Escalier and Bonnarel, C‑260/06 and C‑261/06, EU:C:2007:659, paragraph 28).
52


Member States must, in that case, by a simplified procedure, determine whether the import of a veterinary medicinal product which has an MA in another Member State is a parallel import by reference to a veterinary medicinal product which already has an MA in the Member State of import, since they are obliged to ensure compliance with the obligations and prohibitions laid down in Directive 2001/82 (see, by analogy with plant protection products, judgment of 8 November 2007, Escalier and Bonnarel, C‑260/06 and C‑261/06, EU:C:2007:659, paragraphs 29 and 32).
53


If the veterinary medicinal product concerned must be regarded as having already been authorised in the Member State of importation, the competent authorities of that State must, by a simplified procedure, grant livestock farmers, who wish to import veterinary medicinal products for use on their own livestock farms, a parallel import authorisation, unless that is precluded by considerations relating to the effective protection of human and animal health. Accordingly, a Member State cannot be required to issue a parallel import authorisation automatically or absolutely and unconditionally to livestock farmers wishing to import veterinary medicinal products for use on their own livestock farms (see, by analogy with pharmaceutical products, judgment of 12 November 1996, Smith & Nephew and Primecrown, C‑201/94, EU:C:1996:432, paragraph 29, and as regards plant protection products, judgment of 8 November 2007, Escalier and Bonnarel, C‑260/06 and C‑261/06, EU:C:2007:659, paragraph 30).
54


Thirdly, it is appropriate to note that Article 5(2) of Directive 2001/82 states that the MA holder is to be responsible for the marketing of the medicinal product. It follows therefrom, as the Court has already held as regards plant protection products (judgment of 8 November 2007, Escalier and Bonnarel, C‑260/06 and C‑261/06, EU:C:2007:659, paragraphs 38 to 42 and 50), that livestock farmers, in order to be able to make parallel imports of veterinary medicinal products identical or similar to veterinary medicinal products which, in the Member State of import, have obtained an MA in accordance with Directive 2001/82, must hold an MA issued, even if by a simplified procedure, by the competent national authorities and become responsible for marketing the veterinary medicinal products imported in parallel in the Member State of import.
55


That finding, first, ensures that Article 5(2) of Directive 2001/82, under which the MA holder is responsible for marketing the veterinary medicinal product concerned, is effective and, secondly, guarantees the essential aim of safeguarding public health, as is clear from recital 2 of that directive. A person who has obtained authorisation to import a veterinary medicinal product in parallel is best placed to bear, in respect of that medicinal product, the responsibilities connected with the marketing of the veterinary medicinal product in question. In addition, since MAs may be re-examined and may be cancelled, Member States must, in such cases, be able to ensure the withdrawal as soon as practicable of all the products concerned on their territory, which would not be possible if an MA was not personal and if, in circumstances such as those of the main proceedings, every livestock farmer wishing to import in parallel veterinary medicinal products for the needs of his livestock farm were not required to obtain an MA (see, by analogy as regards plant protection products, judgment of 8 November 2007, Escalier and Bonnarel, C‑260/06 and C‑261/06, EU:C:2007:659, paragraph 41).
65


In that regard, apart from the fact that the interpretation of the national legislation given by the French Government does not differ greatly from that given by the referring court, it should also be noted that it is not for the Court, in the context of a reference for a preliminary ruling, to give a ruling on the interpretation of provisions of national law or to decide whether the interpretation given by the national court of those provisions is correct. Indeed, only the national courts are competent to decide upon the interpretation of domestic law (judgment of 17 December 2015, Tall, C‑239/14, EU:C:2015:824, paragraph 35 and the case-law cited).
66


Consequently, as regards the first question as set out in paragraph 63 of this judgment, it must be observed that, in accordance with settled case-law, all measures of a Member State which are capable of hindering, directly or indirectly, actually or potentially, trade within the European Union are to be considered as measures having an effect equivalent to quantitative restrictions on imports within the meaning of Article 34 TFEU (see, inter alia, judgments of 11 July 1974, Dassonville, 8/74, EU:C:1974:82, paragraph 5, and of 23 December 2015, Scotch Whisky Association and Others, C‑333/14, EU:C:2015:845, paragraph 31).
69


In accordance with settled case-law, a measure having equivalent effect to a quantitative restriction on imports can be justified, for example, on grounds of the protection of human and animal health only if that measure is appropriate for securing the achievement of the objective pursued and does not go beyond what is necessary in order to attain it (see, to that effect, judgment of 23 December 2015, Scotch Whisky Association and Others, C‑333/14, EU:C:2015:845, paragraph 33 and the case-law cited).
70


As regards the objective pursued by the legislation at issue in the main proceedings, it must be noted that public health ranks foremost among the assets or interests protected by Article 36 TFEU and it is for the Member States, within the limits imposed by EU law, to decide on the degree of protection which they wish to afford to human health and on the way in which that protection is to be achieved (see, inter alia, judgments of 11 December 2003, Deutscher Apothekerverband, C‑322/01, EU:C:2003:664, paragraph 103, and of 9 December 2010, Humanplasma, C‑421/09, EU:C:2010:760, paragraph 32).
80


Consequently, it is appropriate to find that the articles of the Public Health Code relating to the pharmacovigilance obligations, cited in paragraph 77 of this judgment, merely comply with the rules of pharmacovigilance laid down in Directive 2001/82. Those articles cannot thus be classified as measures having an effect equivalent to a quantitative restriction on imports within the meaning of Article 34 TFEU (see, to that effect, judgment of 23 March 2000, Berendse-Koenen, C‑246/98, EU:C:2000:153, paragraph 25).