The Queen v Ministry of Agriculture, Fisheries and Food, ex parte: British Agrochemicals Association Ltd.
Date: 1999-03-11
26 In that connection, it should be borne in mind that in De Peijper the Court held, at paragraphs 21 and 36, in the context of Articles 30 and 36 of the EEC Treaty, that, if the public health authorities of the importing Member State already have in their possession, as a result of a previous importation having led to the grant by those authorities of marketing authorisation, all the particulars for the purpose of checking that a medicinal preparation is effective and not harmful, it is clearly unnecessary, in order to protect the health and life of humans, for the said authorities to require a second trader who has imported a medicinal preparation which is in every respect the same or displays differences which have no therapeutic effect, to produce the abovementioned particulars to them again.
27 Furthermore, in Case C-201/94 Smith & Nephew Pharmaceuticals and Primecrown [1996] ECR I-5819, paragraph 21, concerning the interpretation of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 20), as amended in particular by Council Directive 87/21/EEC of 22 December 1986 (OJ 1987 L 15, p. 36, hereinafter `Directive 65/65'), the Court considered that that directive could not apply to a proprietary medicinal product covered by marketing authorisation in one Member State and imported into another Member State as a parallel import of a proprietary medicinal product already covered by marketing authorisation in the latter Member State, since that imported product cannot, in such a case, be regarded as being placed on the market for the first time in the Member State of importation.
28 It went on to explain, at paragraphs 25 and 26 of that judgment, that the competent authority in the Member State of importation must verify that the two proprietary medicinal products, which have a common origin by virtue of the fact that they are manufactured pursuant to agreements concluded with the same licensor, if not identical in all respects, have at least been manufactured according to the same formulation, using the same active ingredient, and have the same therapeutic effects.
31 Accordingly, where a plant protection product covered by marketing authorisation granted in accordance with the provisions of the Directive in one Member State is imported into another Member State as a parallel import of a plant protection product already covered by marketing authorisation in the Member State of importation, the provisions of the Directive on the procedure for the grant of marketing authorisation do not apply.
32 Where two marketing authorisations are granted in accordance with the Directive, the objectives which it pursues as to protection of human and animal health and of the environment do not call for the same treatment.  In such a situation, application of the Directive's provisions concerning the procedure for the grant of marketing authorisation would go beyond what is necessary to achieve those objectives and could, without justification, run counter to the principle of the free movement of goods laid down in Article 30 of the Treaty.
33 It is important, however, that the competent authority should verify, apart from the existence of a common origin, that the two plant protection products, if not identical in all respects, have at least been manufactured according to the same formulation, using the same active ingredient, and also have the same effect with due regard, in particular, 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.
34 In order to verify that those conditions are met, the competent authority of the Member State of importation has available to it, as the Court pointed out in paragraph 27 of the judgment in Smith & Nephew and Primecrown, legislative and administrative means capable of compelling the manufacturer, his duly appointed representative or the licensee for the plant protection product already covered by marketing authorisation to supply information in their possession which the authority considers to be necessary. Moreover, the competent authority may consult the file submitted in connection with the application for marketing authorisation in respect of the plant protection product already authorised.
36 If, on completion of the examination carried out by the competent authority of the Member State of importation, the latter finds that all the abovementioned criteria are fulfilled, the plant protection product to be imported must be considered to have already been placed on the market of the Member State of importation and, accordingly, must be able to benefit from the marketing authorisation granted in respect of the plant protection product already on the market, unless that is precluded by considerations concerning the effective protection of human and animal health and of the environment.
37 If the competent authority finds that the plant protection product to be imported from another Member State does not fulfil all the abovementioned criteria and the product cannot therefore be deemed to have already been placed on the market in the Member State of importation, that authority may grant the authorisation required for the marketing of the plant protection product to be imported only in compliance with the conditions laid down in the Directive.
40 Accordingly, it must be held, on the same grounds as those mentioned at paragraph 33 above, that, where the competent authority of a Member State finds that a plant protection product imported from an EEA State in which it is already covered by 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.