Commission of the European Communities v French Republic.
Date: 2008-02-21
30. This action raises the question whether Article 28 EC precludes Article 1 of Decree No 2001-317 in so far as the latter restricts the simplified authorisation procedure for the parallel importation of plant protection products only to cases where the imported product and the reference product have a common origin, in the sense that they have been manufactured according to the same formulation by the same company or by an associated undertaking or under licence.
31. 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 (see to that effect, Joined Cases C-260/06 and C-261/06 Escalier and Bonnarel  [2007] ECR I-0000, paragraph 24).
32. However, Directive 91/414 tempers that principle by providing, in Article 10(1), that, when there is presented in one Member State a marketing authorisation application for a plant protection product already authorised in another Member State, the former State must, subject to certain conditions and allowing for certain exceptions, refrain from requiring the repetition of tests and analyses already carried out in that other State, which thereby permits a saving of time and money involved in gathering the required information (see Escalier and Bonnarel , paragraph 25).
33. By contrast, Directive 91/414 contains no specific provision as regards parallel imports by which an operator buys a product in one Member State for the purpose of reselling it in another in order to benefit from a difference in price between those two geographical markets. The directive does not set out the conditions for the authorisation of a plant protection product covered by a marketing authorisation granted in accordance with its provisions and imported in parallel to a plant protection product already covered by a marketing authorisation in the Member State of importation. Such a situation falls, however, 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 28 EC et seq. (see, to that effect, Escalier and Bonnarel , paragraph 28, and Commission  v Germany , paragraph 27).
34. Where such an operation relates to a plant protection product which has already been authorised in accordance with Directive 91/414 in the Member State of exportation and in the Member State of importation, that product cannot be regarded as being placed on the market for the first time in the Member State of importation. It is not therefore necessary, in order to protect human and animal health and the environment, to make parallel importers subject to the marketing authorisation procedure provided for by that directive, given that the competent authorities in the Member State of importation already have all the information necessary for the exercise of that scrutiny. To make the imported product 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 could, without justification, run counter to the principle of the free movement of goods laid down in Article 28 EC (see, to that effect, British Agrochemicals Association , paragraph 32).
35. In that regard, the Court has already held that if a plant protection product must be regarded as having already been authorised in the Member State of importation, the competent authorities of that State must allow the product concerned to benefit from the marketing authorisation granted 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 ( British Agrochemicals Association , paragraph 36).
36. 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 Member State of importation, that State must issue a marketing authorisation according to the conditions laid down by Directive 91/414 or prohibit its being placed on the market and used (see, to that effect, British Agrochemicals Association , paragraph 37, and Escalier and Bonnarel , paragraphs 30 and 31).
37. In order to verify whether a product authorised in another Member State in accordance with Directive 91/414 is to be regarded as having already been authorised in the Member State of importation, it is for the competent authorities of that Member State (i) to ascertain whether the importation of the plant protection product covered by the marketing authorisation in the other Member State constitutes a parallel import of a product already covered by a marketing authorisation in the Member State of importation, and (ii) to examine, when requested by the parties concerned, whether the product concerned may have the benefit of the marketing authorisation issued in favour of a plant protection product already on the market of the Member State of importation.
38. To that end, the notion of common origin allows parallel imports to be distinguished from other situations in which the importer of a product authorised in another Member State seeks to benefit from a marketing authorisation already granted in the Member State of importation. Furthermore, a common origin constitutes an important indication that the products at issue are identical, which would show that the marketing authorisation for the reference product may be used for the imported product (see, to that effect, Kohlpharma , paragraphs 16 and 17).
39. In paragraph 40 of British Agrochemicals Association , the Court ruled that where the competent authority of a Member State finds that a plant protection product imported from a State party to the Agreement on the European Economic Area in which it is already covered by a marketing authorisation granted in accordance with the Directive, if not identical in all respects to a product already authorised within the Member State of importation, at least,
– shares a common origin with that product in that it has been manufactured by the same company or by an associated undertaking or under licence according to the same formulation,
– was manufactured using the same active ingredient, and
– also has 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,
that product must be able to benefit from the marketing authorisation already granted in the Member State of importation, unless that is precluded by considerations concerning the protection of human and animal health and of the environment.
41. Contrary to what the Commission submits, Kohlpharma  does not call that assessment into question. In that case, the Court took as a basis the premise that, for the purposes of assessing their safety and efficacy, the imported medicinal product and the reference medicinal product did not differ significantly although they had been manufactured by two separate undertakings. After pointing out that the principle of proportionality requires that the legislation in question be applied within the limit of what is necessary in order to achieve its primary objective of protecting public health, the Court stated that the circumstances of that case were characterised by the fact that the active ingredient had been sold to two different manufacturers of medicinal products established in two Member States, with the result that the applicant for the parallel import authorisation could, for the purpose of assessing its safety and efficacy, demonstrate by means of available or accessible information that the medicinal product to be imported did not differ significantly from the medicinal product which had already been authorised ( Kohlpharma , paragraphs 11, 14 and 19). In such circumstances, the assessment of safety and efficacy carried out for the medicinal product which had already been authorised could be used in the application for a marketing authorisation for the second medicinal product without any risk to public health ( Kohlpharma , paragraph 21, third indent).
45. It must therefore be held that, by requiring, for the purpose of the grant of an import authorisation for a plant protection product, that the imported product and the product already authorised in France must have a common origin, the French Republic has not failed to fulfil its obligations under Article 28 EC.