C-100/96

* Original language: French. 2 — I'ourth, ninth and tenth recitals. I — OJ 1991 L 230, p. 1. 3 — Fifth and sixteenth recitals.

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5. To that end, the Community legislature consignment from the territory of the Com- adopted provisions designed to harmonise munity or disposal. Importation of a plant national rules governing the conditions and protection product into the territory of the procedures for the granting of marketing Community shall be deemed to constitute authorisation for plant protection products. 4 placing on the market for the purposes of this Directive'. Article 2(11) provides that 'autho- risation of a plant protection product' is the 'administrative act by which the competent authority of a Member State authorises, fol- lowing an application submitted by an appli- cant, the placing on the market of a plant protection product in its territory or in a part 6. Article 1(1) provides: 'This directive con- thereof'. cerns the authorisation, placing on the market, use and control within the Community of plant protection products in commercial form and the placing on the market and control within the Community of active substances intended for a use specified in Article 2(1).'

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10. The conditions for inclusion of the active placed on the market'. Article 9(2) stipulates substances in Annex I are set out in Articles that every applicant is required to have a per- 5 and 6 of the directive. Article 5(1) points manent office within the Community. out, in particular, that an active substance may only be included in Annex I if, in the light of current scientific and technical knowledge, it may be expected that plant protection prod- ucts containing the active substance will fulfil certain conditions. 6 14. Article 10 of the directive 7 concerns the mutual recognition 8 by the Member States of marketing authorisations for plant protection products. The first and second indents of Article 10(1) provide that a Member State to which an application is made for a marketing 11. No active substance has yet been included authorisation of a plant protection product in Annex I. already authorised in another Member State must:

12. Until a list of authorised active substances is adopted, transitional and derogating mea- '— refrain from requiring the repetition of sures have been established by Article 8 of tests and analyses already carried out in the directive for obtaining, reviewing and connection with the authorisation of the withdrawing marketing authorisations for product in that Member State, and to the those products, a provision which is relevant extent that agricultural, plant health and to this case. I will return to it later. environmental (including climatic) con- ditions relevant to the use of the product arc comparable in the regions concerned,

15. Restrictions and exceptions to the prin- 18. The 1994 Control Arrangements, 10 which ciple of mutual recognition are strictly defined entered into force on 14 March 1994, were by Articles 10 and 11 óf the directive. drawn up pursuant to the Control of Pesti- cides Regulations 1986, " introduced on 6 October 1986. The 1994 Control Arrange- ments extended the previous system, which only concerned parallel imports coming from the Member States, to cover those coming from countries which are not members of the European Community. They maintain the 16. Annex II to the directive relates to the provision under which it is for the parallel requirements for the dossier to be submitted importer to certify that the imported product for the inclusion of an active substance in is identical to the master product. Annex I, and Annex III to the requirements to be fulfilled for the dossier to be submitted for the marketing authorisation of a plant protection product.

19. Furthermore, that legislation provides, in substance, that no person may advertise, sell, supply, store or use pesticide product in the 17. As stated above, the list of active United Kingdom unless the Ministers have substances included in Annex I has not yet jointly given in respect of it a provisional or been drawn up. Accordingly, the provision full approval under Regulation 5 of the Con- for the automatic recognition by a Member trol of Pesticides Regulations and all relevant State of those products already authorised by conditions are complied with. another Member State is not yet applicable.

21. Clause 6 provides that the file to be sub- mitted in support of an application for mar- keting authorisation must contain, first, a cov- ering letter giving the name of both the master product and the imported product and the 24. In support of its application, the appli- type of approval sought and, secondly, evi- cant claims that the 1994 Control Arrange- dence that the product to be imported is ments are in breach of the directive by allowing identical, according to specific criteria, to the an imported product onto the market on the United Kingdom master product. This may basis that it is identical to a master product either be a sample of the original label of the already approved in the United Kingdom fol- product to be imported or a copy of the label lowing tests, even though the components of of the product for which the importer is the master product differ in their nature, seeking approval to import. quality and quantity from the imported product. It submits that the directive docs not provide for the issuing of a marketing autho- risation following a speedy procedure on the ground that the formulation of the master 22. Clause 9 provides that the authority product and the imported product is iden- responsible for marketing authorisations may tical. Rather, the directive puts in place a

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26. The national court considered that the (ii) the formulation of the imported solution of the dispute required an interpreta- product is produced by the same tion of the relevant Community provisions company (or by an associated under- and referred the following questions to the taking or under licence) as that of Court of Justice for a preliminary ruling: the master product and any differ- ences in the nature, quality and quan- tity of the components are deemed by the registration authority to have no material effect on the safety of humans, domestic animals, livestock, '1. Does Directive 91/414/EEC of 15 July . wildlife or the environment gener- 1991 as amended allow a Member State ally or on efficacy?

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2. Does Directive 91/414/EEC of 15 July 28. The second question clarifies Question 1991 permit a Member State to allow a l(ii). It is a question of determining whether plant protection product imported from the authority competent for the issuing of another EEA State or from outside the marketing authorisations for plant protection EEA onto the market as identical (as products may authorise a product imported defined in 1 above) to a master product from an EEA State or a third country to be without any analysis of the actual con- placed on the market on the basis that the tents of the imported product prior to components of the imported and master prod- placing on the market? ucts arc identical — according to pre- established criteria — without any previous comparative tests on those components.

3. If the answer to 1 above is in the affir- mative, does Article 9(2) of Directive 29. Although the national court docs not 91/414/EEC of 15 July 1991 permit a make it clear, I assume that the imported Member State to allow a plant protec- product was duly placed on the market of the tion product imported from countries State of origin. 12 outside the EEA onto the market when the importer or person placing the product on the market is a person without a permanent office within the EEA?'

by Article 110 and the first paragraph of certain Annexes to the EEA Agreement 1 7 Article 234 of the EC Treaty 13 and, on the (hereinafter 'Decision N o 7/94'), which other, by the international agreements to which entered into force on 1 July 1994, l s which the Community has acceded, such as the expressly provides that Council Directive General Agreement on Tariffs and Trade 91/414, amended by Commission Directive ('GATT'), M and the Agreement on the Euro- 93/71/EEC of 27 July 1 9 9 3 , " is applicable pean Economic Area ('EEA Agreement') throughout the EEA. adopted by Decision 94/1/ECSC, EC of the Council and the Commission of 13 Decem- ber 1993. 15

33. Finally, after 1 July 1994, the issuing within an EEA State of a marketing authori- 31. So far as concerns the EEA States, Arti- sation for a plant protection product is sub- cle 8(1) of the EEA Agreement provides: 'The ject to the strict observance of the require- free movement of goods between the con- ments of the directive. tracting parties shall be established in confor- mity with the provisions of this agreement'.

34. There could be a problem for the national u court in deciding which law is applicable at 32. Annex II of the EEA Agreement, which the relevant time. It is for the national court deals with technical regulations, standards, to determine, in accordance with its own testing and certification, was revised by Deci- domestic law and all the evidence before it, sion of the EEA Joint Committee N o 7/94 of under which body of provisions the case 21 March 1994 amending Protocol 47 and before it must be decided.

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identical, the rules which govern the par- 37. For a transitional period and until Annex allel import of a product coming from a I establishing the list of active substances Member State will also apply to the par- which the Community permits to be included allel importation of a product coming from in plant protection products is drawn up, an EEA State ('Possibility One'); those requirements may be found in Article 8.

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40. It is clear from the wording itself of those the discretion reserved to the competent provisions — as the law stands at present — 20 national authorities. that those full, detailed and therefore neces- sarily binding procedures relate only to a first application to pL·^ on the market a plant pro- tection product not yet authorised in the Member State in which marketing authorisa- tion is sought. 44. The Court, having regard to the essential aim of that legislation — namely the placing on the market of a medianal product whose efficacy, harmlessness and quality are proven —, ruled that the competent national authority 41. That reading is, moreover, in keeping does not have any discretion to reL·x or dero- with the dual objective pursued, which is to gate from the conditions tád down by Direc- ensure that a product placed on the market is tive 65/65. 23 completely safe and to facilitate the free move- ment of goods.

45. Given the manifold aims of the legisla- tion on medicinal products, 24 the Court thus 42. Nevertheless — and I must stress this chose to give priority to the aim of protecting point — the system put in place rests on the public health. assumption that each Member State will observe strictly and scrupulously all the provi- sions of the directive.

46. Faced with a comparable choice — the free movement of goods and the probable 43. I consider that, in this regard, the judg- risks to public health — the Court confirmed ment in Scotia Pharmaceuticals is perfectly the position taken in the Scotia Pharmaceu- capable of being transposed to the present ticals case in the order which it made on case. 21 In that case, it was necessary to examine 12 July 1996 in United Kingdom v Commis- Community legislation concerning marketing sion. 25 The United Kingdom had asked the authorisations for medicinal products for Court to make an interim order suspending human use 22 and to determine the extent of the operation of Commission Decision 96/239/EC of 27 March 1996 on emergency

48. The Court observed that, even though it was not absolutely certain that BSE could be transmitted to human beings, there existed a serious risk. Accordingly, the Court refused to grant the application, pointing out that the interests of the protection of public health (paragraphs 89, 90 and 92) had to prevail over other considerations, in particular, the prin- 51. In the light of the preceding arguments, ciple of the free movement of goods within since the procedures laid down in both Articles the Community. The Court underscored the 4 and 8 of the directive apply only where a fact that 'it cannot but recognise the para- plant protection product being placed on the mount importance to be accorded to the pro- market for the first time is not yet authorised tection of health' (paragraph 93 of the order). in the Member State in which marketing authorisation is sought, I consider that the practical effect of the directive would be under- mined if those procedures had to be used each time a marketing authorisation is sought for a product displaying properties and character- 49. That having been said, assuming that each istics identical to those of a product already Member State observes strictly those require- authorised by that Member State. To decide ments with regard to the granting of mar- otherwise would amount to requiring the keting authorisations for plant protection issuing of two marketing authorisations for products, the marketing authorisation granted the same product, contrary to the wording for such products under a harmonised proce- and objectives of the directive. dure is a guarantee of safety, efficacy and

55. Subsequently, on the basis of the De Peijper case, 33 the Court stated that the objec- tive of safeguarding public health '... justifies 53. In Smith & Nephew, the Court was asked such stringent measures only in regard to to interpret the provisions of Directive 65/65, proprietary medicinal products which are as amended by Council Directive being put on the market for the first time', 34 87/21/EEC, 29 relating to the conditions to be and concluded that 'the provisions of Direc- fulfilled and the procedure to follow in order tive 65/65 concerning the procedure for issue to obtain a marketing authorisation for a of marketing authorisations cannot apply to medicinal product for human use. In par- a proprietary medicinal product covered by a ticular, the Court was asked whether — in marketing authorisation in one Member State circumstances similar to those of the present which is being imported into another Member case — the mandatory provisions laid down State as a. parallel import of a product already by Directive 65/65 also applied to applica- covered by a marketing authorisation in that tions for marketing authorisations for parallel other Member State. In such a case, the imports of medicinal products from other imported proprietary medicinal product Member States. 30 cannot be regarded as being placed on the market for the first time in the Member State of importation'.35

54. The Court observed that the primary purpose of Directive 65/65 was to ensure that 'when a proprietary medicinal product is mar- (b) Possibility Two keted, public health is safeguarded by means which cannot hinder the development of the pharmaceutical industry or trade in medicinal products within the Community' 31 and that, to that end, it 'requires that a series of docu- ments as well as precise, detailed information 56. So far as third countries are concerned, be produced as a pre-condition to the granting not only does the directive not apply in their of a marketing authorisation, even where the territory, but no harmonisation of the condi- proprietary medicinal product in question is tions for granting marketing authorisations

(a) Possibility One 3 7

59. The national court's questions concern the interpretation of the directive's provi­ sions. If I were to restrict myself to the wording of those questions, and conclude that 62. The De Peijper case, cited above, pro­ the procedures for granting marketing autho­ vides some guidance for the national court. In risations for plant protection products have that case, the Court was asked, first, whether no bearing on parallel imports, I could not go the provisions which make the granting of any further in examining the questions. marketing authorisations for plant protection products for human use subject to the pro­ duction of the same particulars and analyses as those enabling a national authority to issue a marketing authorisation for a master product, in order to ascertain that the product parallel imported from a Member State and 60. However, the Court has consistently held that the nature of the preliminary ruling pro­ cedure is based on the assumption that the Court takes account of the real purpose of 36 — Sec, in particular, Case 16/65 Schwarze v Hinfuhr- und Vor- rastsstcllc Getreide [1965] ECR 877. the questions raised by the national court, as 37 — Sec point 36 of this Opinion.

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67. In the present case, the essential aim of tific publications, on the basis of which the Directive 91/414 is to ensure the use of plant application for authorisation was submitted protection products which offer a high stan- under the abridged procedure, were still up dard of protection of human and animal health to date'. and of the environment. The Court so held in its judgment in Parliament v Council. 43

68. Furthermore, the Community legislature has provided that the implementation of the 69. It is common ground that not only has directive and the adaptation of its annexes scientific progress made it possible to refine must be carried out in the light of 'advances ever more research and knowledge in fields in technical and scientific knowledge'. 44 The such as that of comparative tests to establish need to take into account that factor is sys- whether two plant protection products arc tematically pointed out by the Community identical, but also that development of tech- legislature in the various legal instruments nology makes it easier to carry out such tests. introduced in the field of the authorisation for the marketing of pharmaceutical prod- ucts. 45 The Court has not failed to point out the need to observe that requirement, for in paragraph 21 of Scotia Pharmaceuticals, cited above, it held that:

70. Finally, the Court stated in Scotia Phar- maceuticals, cited above, that 'the abridged procedure in no way relaxes the requirements '... the competent authority may also use its of safety and efficacy which must be met by power of assessment to ascertain whether or medicinal products'. ' ,6 By analogy, I consider not the applicant seeking an authorisation, that the procedure which must be followed in and consequently the expert who prepared the case of parallel imports of plant protec- the documentation supporting the applica- tion products cannot result in the introduc- tion, took account of current technical devel- tion onto the market of products capable of opments and scientific progress and whether presenting a hazard for human health. or not he or she was satisfied that the scien-

judgment in Scotia Pharmaceuticals, for has displayed special vigilance when assessing checking whether products are identical. the identicality of the two products. The national authority must establish, having com­ pared the results of simüar tests and analyses which are relevant and up to date, account being taken of scientific progress and tech­ nical developments, that the products under 72. The Court's judgment in Smith & comparison are indeed identical in every Nephew, cited above, 4 7 expressly* refers t o respect, That is so if those products have the De Peijper and specifically reproduces para­ same components — in particular as regards graph 10 thereof. It is for this reason that I not only the active substances but also the consider that it must be interpreted in the proportion of active substances to other light of those arguments. substances; if they have the same effect on plants and are used in the same proper way (having regard to whether conditions as to agriculture, plant health and environment, in particular climatic conditions, relevant to the use of the products are comparable in the 73. Finally, in order to deal specifically with regions concerned in the State of origin and in the State of importation); if they have the the concern expressed by the national court same harmless side-effects and, in any event, in its second question, according to the judg­ if they likewise have no harmful side-effects ment in De Peijper, 4 S it is not absolutely nec­ on humans, animals and the environment. In essary to carry out tests again if the national other words, it is a question of ensuring that, authority already has in its possession the sci­ in all those various respects, the differences entific particulars which were delivered to it between the two products are negligible. with the first application for placing on the market. Moreover, the authority could pos­ sibly, in coordination with the authority of the Member State where the imported product originates, obtain information to supplement the information provided by the importer. 4 9 That comparative examination should be easily accomplished since the two products were authorised in countries which comply with the procedure for the issue of marketing authorisation provided for by the directive.

(b) Possibility Two 50 80. Consideration of the first question leads me to the conclusion that the rigorous pro- cedure and conditions provided for by the directive arc required only if the plant protec- 77. The Treaty, in particular Article 110 and tion product has never been placed on the the first paragraph of Article 234 thereof, and market in the Member State of importation. the GATT Agreements preclude any unjusti- On the other hand, in the case of a parallel fied barrier to international trade. 5 1 I am import, according to the judgment in De therefore of the view that the solution set out Peijper, the national authority ofthat Member under Possibility One may be adopted in the State must ascertain that the products com- case of a plant protection product imported pared arc indeed identical in every respect, from a third country where that product is according to previously defined criteria. More- identical to a plant protection product already over, the criterion that the components of the on the market in the Member State of impor- imported product and the master product are tation. manufactured by the same company is not appropriate.

78. The main difficulty lies in the fact that the imported plant protection product will The third question have been authorised in a State which docs not follow the same procedure and which docs not necessarily require the same tests, analyses and documents before issuing a mar- keting authorisation. 81. If the answer to the first question is in the affirmative, the national court, by its third 50 — Sec the second indeni of point 35 of this Opinion. question, asks the Court to determine whether 51 — Sec, to that effect, in particular, Case 245/81 Edcka v Ger- Article 9(2) of the directive permits a Member many [1982] ECR 2745, Case 45/86 Commission v Council State to allow a plant protection product [1987] ECR 1493, and Case 263/87 Denmark v Commission [1989] ECR 1081. imported from non-EEA countries to be put

84. In so far as the factual situation in respect of which the national court poses its ques- tions to the Court concern parallel imports of plant protection products, the reply must be that that provision is not applicable to the present case. 87. In accordance with what I said in relation to Question l(ii), where the plant protection product imported from a third country is identical — according to the previously defined criteria — to a product authorised in the Member State of importation, the fact that authorisation to place the imported product 85. Nevertheless, as I said above, 52 I con- on the market is granted only to the importer sider that, by this question, the national court or to the person responsible for its placing on is asking the Court to determine whether the market who can show that he has a per- Community law would allow a Member State manent office or establishment within the Community or inside the EEA would con- stitute an unjustified barrier to world trade, 52 — See points 59 and 60 of this Opinion. prohibited by the Treaty.

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Conclusion

88. In the light of the foregoing observations, I propose that the Court should reply as follows to the questions submitted to it by the High Court of Justice, Queen's Bench Division, for a preliminary ruling:

(1) (a) Articles 4 and 8 of Council Directive 91/414/EEC of 15 July 1991 con- cerning the placing of plant protection products on the market do not apply to applications for authorisation to place on the market plant protection products imported from another Member State, a European Economic Area (EEA) State or a third country and authorised in those States of origin, where the product is identical to a plant protection product already autho- rised in the Member State in which authorisation to place on the market is sought.

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The products are also identical if the differences found in relation to those various aspects are negligible with regard to the therapeutic effi- cacy, the safety and the quality of the imported product under con- sideration.

(b) (ii) The criterion that the active substance or the components of the imported plant protection product and the master product are manu- factured by the same company, by a company belonging to the same group or under licence is necessary but insufficient in order to char- acterise the two products as identical.

(b) (iii) Where, on the basis of those criteria, the competent authority of the Member State of importation finds that the two products are identical, it must grant, for the imported plant protection product, the authorisa- tion to place on the market which it previously granted to the master product, unless considerations concerning the effective protection of the health and lives of humans and animals and of the environment preclude this, without being required to have the constituents of the imported product analysed beforehand.

(2) The competent authority of a Member State may permit the placing on the market of a plant protection product imported from a third country as being identical [according to the criteria set out in Question 1(b)] to the master product, even if the importer or the person responsible for placing it on the market does not have its permanent office in the Community or within the EEA.