Mac GmbH v Ministère de l’Agriculture, de l’Agroalimentaire et de la Forêt.
Date: 2014-11-06
24. It should be noted, first, that plant protection products are to be regarded as identical if, at least, they share a common origin in that they have been manufactured by the same company or by an associated undertaking or under licence according to the same formulation, were manufactured using the same active ingredient, and also have the same effect with due regard to differences which may exist in conditions relating to agriculture, plant health and the environment, in particular climatic conditions, relevant to the use of the product (see, to that effect, judgment in Commission  v France , C‑201/06, EU:C:2008:104, paragraph 39).
25. According to the basic relevant rule, all plant protection products placed on the market of a Member State must be authorised by the competent authorities of that Member State. Article 3(1) of Directive 91/414 thus provides that no plant protection product can be placed on the market and used in a Member State unless a prior marketing authorisation has been issued by that Member State in accordance with the directive. That requirement applies even when the product concerned already has a marketing authorisation in another Member State (judgment in Commission  v France , EU:C:2008:104, paragraph 31).
26. However, as regards parallel imports, Directive 91/414 does not set out the conditions for the authorisation of a plant protection product imported in parallel to a plant protection product already covered by a marketing authorisation in the importing Member State which has been granted in accordance with the directive. Nevertheless, such a situation falls within the scope of the provisions on the free movement of goods, with the result that the legality of national measures restricting parallel imports must be examined in the light of Article 34 TFEU et seq. (see judgments in Escalier and Bonnarel , C‑260/06 and C‑261/06, EU:C:2007:659, paragraph 28, and Commission  v France , EU:C:2008:104, paragraph 33).
27. In that regard, the Court has already held that where such an operation relates to a plant protection product which has already been authorised in accordance with Directive 91/414 in the exporting Member State and in the importing Member State, that product cannot be regarded as being placed on the market for the first time in the importing Member State. It is not therefore necessary, for the purpose of protecting human and animal health and the environment, to make parallel importers subject to the marketing authorisation procedure laid down by that directive, given that the competent authorities in the importing Member State already have all the information necessary for the exercise of that scrutiny. To make the product to be imported subject to the marketing authorisation procedure would go beyond what is necessary to achieve the objectives of Directive 91/414 as to the protection of public and animal health and of the environment and may, without justification, run counter to the principle of the free movement of goods laid down in Article 34 TFEU (see judgments in British Agrochemicals Association , C‑100/96, EU:C:1999:192, paragraph 32, and Commission  v France , EU:C:2008:104, paragraph 34).
28. If a plant protection product must be regarded as having already been authorised in the importing Member State, the competent authorities of that State must allow the product concerned to benefit from the marketing authorisation granted in accordance with Directive 91/414 to the plant protection product already on the market, unless that is precluded by considerations relating to the effective protection of human and animal health and of the environment (see judgments in British Agrochemicals Association , EU:C:1999:129 paragraph 36, and Commission  v France , EU:C:2008:104, paragraph 35).
29. However, a plant protection product introduced into the territory of a Member State as a parallel import cannot, automatically or absolutely and unconditionally, have the benefit of a marketing authorisation issued to a plant protection product already on the market of that State. If the plant protection product cannot be regarded as having already been authorised in the importing Member State, that State may issue a marketing authorisation for that product only in accordance with the conditions laid down by Directive 91/414 or prohibit its being placed on the market and used (see, to that effect, judgment in Commission  v France , EU:C:2008:104, paragraph 36 and the case-law cited).
30. It follows from the foregoing that Member States are required to subject plant protection products which are intended to be imported into their territory as parallel imports to an examination procedure, which can, as in the case before the national court, take the form of a ‘simplified’ procedure. The purpose of such a simplified parallel import authorisation procedure is to verify whether the product to be imported requires a marketing authorisation or whether it should be treated as already having been authorised in the importing Member State. It is for the competent authorities of the importing Member State to examine, when requested by the parties concerned, whether they can allow the product in question to have the benefit of a marketing authorisation issued in favour of a plant protection product already on the market of that State (see, to that effect, judgments in Escalier and Bonnarel , EU:C:2007:659, paragraph 32, and Commission  v France , EU:C:2008:104, paragraph 37).
33. However, in the event that it cannot be established that the product to be imported and the reference product are identical, the authorities of the importing Member State may authorise the importation of the former product only if the conditions laid down in Directive 91/414 are complied with or prohibit its being placed on the market and used (see, to that effect, judgment in Commission  v France , EU:C:2008:104, paragraph 36 and the case-law cited).
36. Second, as the Court has already observed, the authorities of the importing Member State have available to them legislative and administrative means of compelling the manufacturer, his duly appointed representative or the licensee for the plant protection product already covered by marketing authorisation granted in accordance with Directive 91/414 to supply information in their possession which the authorities consider necessary. Those authorities may also consult the file submitted in connection with the application for marketing authorisation of that product and seek information from the authorities of the Member State in which the product was authorised as a parallel import (see judgment in British Agrochemicals Association , EU:C:1999:129, paragraph 34). Thus, Article 9(5) of Directive 91/414 provides that Member States are to make available, on request, to the other Member States the files which they are required to compile on each application for authorisation and supply to them all information necessary for the full comprehension of the applications.
39. While it is for the national authorities to ensure that the primary objective of EU legislation, namely the safeguarding of human and animal health and the environment, is strictly observed, the principle of proportionality nevertheless requires that, in order to protect the free movement of goods, the legislation in question be applied within the limits of what is necessary in order to achieve the aim of protection of the environment and of human and animal health that is legitimately being pursued (see judgment in Escalier and Bonnarel , EU:C:2007:659, paragraph 37).