C-127/95

* Original language: French. 1 — Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member Sutes relating to veterinary medicinal products (OJ 1981 L 317, p. 1, herein- after 'Directive 81/851'). 2 — Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member Sutes relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal 5. Pen & Strep was first marketed in Ireland products (OJ 1981 L 317, p. 16, hereinafter 'the "standards and protocols" directive' or 'Directive 81/852'). and the United Kingdom in 1968, the

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10. That request for further information from the VMD lies at the root of the dispute which brought Norbrook to the High Court 8. Following receipt of those new data, the of Justice in Northern Ireland, Queen's V M D asked Norbrook to communicate to it Bench Division, whose judgment was set certain information as to the identity and aside on appeal by the Court of Appeal. Tak- location of those suppliers of SS and as t o ing the view that an interpretation and a the manufacturing and control methods of determination of the validity of the relevant that product. Faced with silence from Nor- Community provisions were necessary in brook, the VMD notified the company on 13 order to resolve the dispute, the Court of Appeal has referred the following seven

3 — See paragraphs 14 to 31 of this Opinion. 4 — See paragraph 36 of this Opinion. 5 — Paragraph 2.7 of Norbrook's observations.

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2. Is it material to the answers in Ques- tions 1 (a) to (d) above whether the pro- (b) to require an applicant for a market- cess of manufacture of the Product is ing authorisation to submit to the continuous or other than continuous, competent authority for approval and, if so, what would be the effect on the results of such control tests as the answers to those questions?

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3. Would it be material to the answers to (ii) If they are to be applied by the Questions 1(a) to (d) above if it were national court, by reference to not reasonably possible for an applicant what criteria and considerations to obtain any of the information must the proportionality of the referred to in Question 1(a) and, if so, requests and requirements be what would be the effect on the answers assessed? to those questions?

5. Are Articles 30 to 36 of the EC Treaty to be interpreted as prohibiting requests and requirements such as those described above, or any of them? 4. (a) If the requests for further infor- mation and the other requirements described in Question 1 above, or any of them, are prima facie permis- sible under Council Directive 81/851/EEC and 81/852/EEC, must such requests and requirements 6. (a) Is Article 40 of Council Directive comply with the Community law 81/851/EEC to be interpreted as principle of proportionality? applying to the requests and requirements described above?

(b) If so, in what circumstances and by reference to what criteria are the (b) If the answer to (a) is affirmative, reasons for the imposition of such are those principles to be applied in requests and requirements to be this case by the national court or by treated as inadequate for the the Court of Justice? purposes of Article 40, and were such requests and requirements adequately reasoned in the present case?

(iv) are insufficiently reasoned 13. If the first question is answered in the within the meaning of Article 40 negative, the Court is asked finally, in the of Directive 81/851? seventh question, what the necessary condi- tions are for a Member State to incur liability for a breach of Community law.

(b) If the answer to Question 7(a)(i), (ii), (iii) and (iv) or any of them is in the affirmative, under what condi- Legislative background tions does such liability arise?'

The Community legislation

11. The second and third questions amplify the first, which requests the Court to deter- mine whether Directives 81/851 and 81/852 are to be interpreted as authorising a compe- 14. Within the Union, harmonisation of the tent authority to require an applicant for conditions for granting, suspending and

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17. The national court expressly limits its reference to the rules laid down by the origi- nal versions of Directives 81/851 and 81/852.

6 — Council Directive 65/65/EEC of 26 January 1965 on the 19. Article 4(1) of the directive provides approximation of provisions laid down by law, regulation that: or administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 20, hereinafter 'Directive 65/65'). 7 — See, in particular, one of the most recent judgments in Case C-201/94 Smith & Nephew and Primecrown [1996] ECR I-5819. 8 — See, in particular, the second recital in the preamble t o Commission Directive 92/18/EEC of 20 March 1992 modi- fying the Annex to Council Directive 81/852/EEC on the approximation of the laws of Member States relating t o analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ 1992 L 97, p. 1, hereinafter Directive 92/18'). ' N o veterinary medicinal product may be 9 — 11th recital in the preamble to Directive 81/851. 10 — I have found only one previous judgment concerning the marketed in a Member State unless authori- interpretation of Article 4 of Directive 81/851. It was given sation has previously been issued by the in Case C-297/94 Bruyère and Others v Belgian State [1996] ECR I-1551. competent authority in that Member State.'

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20. Article 5(2) of Directive 81/851 lists 13 consumers, or animal health. It must thus particulars or documents which must be sub- comply with the three criteria commonly mitted in support of an application for mar- defined in this area: quality, harmlessness and keting authorisation. therapeutic effectiveness.

27. The aim of Directive 81/852 is t o approximate the laws of the Member States on control methods for veterinary medicinal products by requiring the competent 24. Article 11 provides that marketing authorities to examine applications for mar- authorisation must be refused if the docu- keting authorisation in accordance with the ments and particulars submitted in support protocols described in the directive. In the of the application do not comply with the first recital in its preamble, the directive provisions of Articles 5, 6 and 7 cited above, states that its aim is to implement the prin- and if the veterinary medicinal product does ciples laid down in Directive 81/851. Thus not ensure the protection of public health, the third recital states that: '... standards and protocols for the performance of tests and trials on veterinary medicinal products are an 11 — Articles 6 and 29 to 31 of Directive 81/851. effective means of control of these products 12 — Ibid., Article 7. and, hence, of protecting public health and

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can facilitate the movement of these products 30. The relevant provisions for answering by laying down uniform rules applicable to the questions referred appear in the first pro- tests and trials and the compilation of dos- tocol. It is divided into six numbered parts siers'. 13 from A to F, concerning respectively: quali- tative and quantitative particulars of the con- stituents (A), description of the method of preparation (B), control of starting materials (C), control tests during manufacture (D), control tests on the finished product (E), 28. The directive lays down the principle of and, finally, stability tests (F). compliance with minimum standards in rela- tion to control methods for veterinary medicinal products:

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33. Marketing authorisations are required 37. It is in the context of that procedure for for all veterinary medicinal products, 20 and 'reviewed' marketing authorisation that the applications for the grant of such authorisa- dispute between Norbrook and the VMD tion must comply with specific criteria and a has arisen. 23 specific procedure. 21

Replies to the questions referred for a pre- liminary ruling concerning the interpreta- tion of Directives 81/851 and 81/852

34. Various information is required 22 in the case of a medicinal product — whether for human or veterinary use — manufactured or assembled in the United Kingdom. Question 1

38. Question 1 essentially concerns two points: the requirements imposed by Direc- tives 81/851 and 81/852 concerning the grant of marketing authorisation and those con- 35. Marketing authorisations are normally cerning the conditions for suspension and valid for five years, unless a shorter duration refusal of such authorisation for a veterinary is specified. medicinal product.

address(es) of the manufacturer(s) and details respect the provisions cited above cannot be of the site(s) where a substance is manufac- interpreted as requiring the performance of tured —, the manufacturing process and the tests which are in practice impossible to control methods used by the manufacturer of carry out. The competent authority may also a substance such as SS. use its power of assessment to ascertain whether or not the applicant seeking an authorisation, and consequently the expert who prepared the documentation supporting the application, took account of current tech- 40. Articles 5, 6, 7 and point 1 of the first nical developments and scientific progress and paragraph of Article 9 of Directive 81/851 whether or not he or she was satisfied that lay down the obligations with which Mem- the scientific publications, on the basis of ber States must comply before granting mar- which the application for authorisation was keting authorisation for a veterinary medici- submitted under the abridged procedure, nal product. The 'standards and protocols' were still up to date.' 25 directive specifies in greater detail the con- trol methods to be applied to a veterinary medicinal product for which marketing authorisation has been applied for.

42. Since the wording of the various provi- 41. As regards the requirements laid down sions in the harmonisation directives con- by the Community harmonisation directives cerning marketing authorisation for both on marketing authorisation for human medi- human and animal medicines is similar, 26 as cines, 24 the Court held in Case C-440/93 R are the aims pursued, 27 the above case-law v Licensing Authority of the Department of must, in my view, be transposed to the Health, ex parte Scotia Pharmaceuticals present case. [1995] ECR I-2851 that the competent authorities are under a strict duty to comply with them:

The description of the starting material shall include the manufacturing strategy, purification/inactivation procedures with their validation and all in-process control 45. In the summary of the factual back- procedures designed to ensure the quality, ground to the main proceedings 29 it is safety and batch to batch consistency of the explained that SS is not an active ingredient, finished product.' 31 but that it goes into the manufacture of the active ingredient, DHS, of which it is the sole ingredient, and that it is manufactured from the disputed product. 30

According to that expert, that 'source mate- rial' is to be assimilated to a 'starting mate- rial' within the meaning of Directives 81/851 and 81/852. The United Kingdom shares that 46. At the hearing, the Commission's expert opinion. 32 stated that the disputed product should be regarded as a 'starting material' within the meaning of Directive 92/18, which provides that:

47. Norbrook disputes the results of the sci- entific analysis undertaken by the Commis- sion and United Kingdom experts and does 'Where source materials such as micro- not agree that SS should be regarded as a organisms, tissues of either plant or animal starting material. It refers to the results of an origin, cells or fluids (including blood) of expert study carried out at its request, and human or animal origin or biotechnical cell argues that Directive 92/18 did not come constructs are used in the manufacture of into force until after the company's dispute with the MAFF.

28 — First protocol of the Annex to Directive 81/852, Part A, point 1, first paragraph, first, second and third indents. 31 — Second part of the first protocol of the Annex to Directive 29 — Page 3 of the order for reference. 92/18, Part C, first and second subparagraphs of paragraph 2, emphasis added. 30 — Not disputed by any of the parties, including Norbrook; see paragraph 1.4 of its observations. 32 — Paragraph 13 of the United Kingdom's observations.

52. However, it is not appropriate to assess the argument based on the expert study car- ried out at the request of Norbrook. Under the first paragraph of Article 14 of Directive 50. To hold otherwise would risk neutralis- 81/851, only the national court, taking ing the effectiveness of such legislation. Since account of the particular characteristics of SS the main aim of this Community legislation and current technological and scientific is to safeguard public health, where new sci- progress, has jurisdiction to assess whether entific data show that more efficient tests are the tests prescribed for starting materials under Directives 81/851 and 81/852 must be carried out on SS. 33 — First paragraph of Part A of the first protocol of the Annex to Directive 81/852. 34 — This provision, which deals with the control methods used by the manufacturer, will be considered in detail in the con- text of the answers to be given to Question 1. 35 — Paragraph 21.

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53. In the remainder of my argument, in stabilisers, thickeners, emulsifiers, anti- order to avoid the trap of reasoning on a agglutinating agents, flavouring and aro- purely hypothetical basis, 36 and taking into matic substances, propellants, etc., account the information contained in the documents before the Court, I can usefully proceed only on the basis put forward by the Commission and the United Kingdom, whereby SS is to be assimilated to a 'starting — the constituents of the pharmaceutical material' within the meaning of the 'stan- form intended to be ingested or other- dards and protocols' directive. 37 wise administered to animals.

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employed in producing the pharmaceu- starting material, is in accordance with the tical form might have produced an provisions of Directives 81/851 and 81/852. adverse change in the constituents;

(2) Particulars of the control methods used by the manufacturer of a starting material

— the actual manufacturing formula, with the quantitative particulars of all the substances used, the quantities of excipients, however, being given in approximate terms in so far as the phar- 59. In Question 1(b), the national court maceutical form makes this necessary; amplifies one of the aspects of Question 1(a), mention shall be made of any by asking whether a national practice con- substances which may disappear in the sisting, among other things, in requiring a course of manufacture; person responsible for marketing a veteri- nary medicinal product to submit for approval the results of tests on each batch of the disputed product purchased by him is permissible. — a statement of the stages of manufacture at which sampling is carried out for in-process control tests, where other data in the documents supporting the application show such tests to be necessary for quality control of the proprietary medicinal product.' 40 60. Article 5, second paragraph, point 9 of Directive 81/851 provides that an application for marketing authorisation must contain a 'description of the control testing methods 58. I therefore have to conclude that, in employed by the manufacturer (qualitative answer to the questions of the referring and quantitative analysis of the constituents court, the requirement that an applicant for and the finished product, specific tests, e. g. marketing authorisation must provide par- sterility tests, tests for the presence of pyro- ticulars of the manufacturing method of the gens, for the presence of heavy metals, stabil- disputed product, in so far as it constitutes a ity tests, biological and toxicity tests, tests on intermediate products).' 41

62. It is clear from the analysis of part C of the first protocol of the Annex to Directive 64. Moreover, I think that it is important t o 81/852 that the concern of the Community point out, having regard to the kind of dis- legislature is, above all, to check that the pute now before the Court — and although starting material, whether listed in a pharma- this concerns only a factual matter — that copoeia or not, was prepared according to a the Commission expert emphasised that the method which cannot leave impurities. 46 risk of any impurities existing in the product in question spreading in the DHS was n o t negligible, in particular because of the use of boron in the SS manufacturing process. That 42 — Second paragraph of Part C of the first protocol of the is why this expert concluded that it is very Annex to Directive 81/852, concerning the control of start- ing materials, emphasis added. important to be able to know the manufac- 43 — Point 1 of Part C of the first protocol of the Annex to turing methods used by SS producers in Directive 81/852. 44 — Ibid., point 2. order to set up the appropriate tests. Again, 45 — Definition given in the Nouveau Larousse Médical: 'Com- still according to the Commission expert, pendium containing: the nomenclature of drugs, simple and composite medicinal products, medicinal articles; a list of common names for medicines; tables of maximum and nor- mal dosages of medicinal products for [the animal]; infor- mation which may be useful to a pharmacist for pharma- ceutical practice'. 47 — First paragraph of point 2(d) of part C of the first Protocol 46 — See, in particular, point 1 of part C of the first part of the of the Annex to Directive 81/852. Protocol of the Annex to Directive 81/852, paragraphs 4, 5 48 — Fourth paragraph of point 1 of the part C of the first Pro- and 7, and point 2 of part C, at (b), (d) and (e). tocol o f the Annex to Directive 81/852.

controls based on analytical tests of the product in question is listed in the existing active ingredient (DHS), of the final product pharmacopoeias 52 — which is for the (Pen & Strep) or the starting material itself national court to determine — the requiring (SS) would be insufficient to exclude all risk particulars of the results of tests on each of impurities in the final product. That batch of starting material is also in confor- analysis was confirmed by the United King- mity with the provisions of Directives dom, 49 but contested by Norbrook. 81/851 and 81/852. However, those direc- tives preclude a competent authority from making the grant of a marketing authorisa- tion for a veterinary medicinal product sub- ject to approval of the batches of starting material entering into the manufacture of the medicinal product. 65. Moreover, if the product in question is listed in a pharmacopoeia, the clarification requested by the national court in point (b) of its first question can also be answered since, in the Annex to Directive 81/852, it is stated that 'the routine tests to be carried out on each batch of starting materials shall be (3) Particulars of the manufacturer of a declared in an application for authorisation starting material to market. These tests must make it possible to provide evidence that each batch of start- ing material satisfies the quality require- ments of the relevant pharmacopoeial mono- graph'. 50 However, as the Commission rightly points out, 51 in no case do Directives 81/851 and 81/852 provide for preliminary approval by the competent authorities of batches used in the manufacture of the medicinal product concerned. 67. These particulars, 53 more precisely the names and addresses of the manufacturer or manufacturers and details of the site or sites of manufacture of a starting material, are not required by Directives 81/851 and 81/852. Point 1 of the second paragraph of Article 5 of Directive 81/851 provides only that the 66. Thus, I propose that the Court should person responsible for marketing must state reply to these points as follows: a request for the 'name or corporate name and permanent particulars of the control methods used by address or registered place of business of the the manufacturer of starting materials is in person responsible for marketing and of the conformity with the requirements of Direc- manufacturer, if different'. By 'manufacturer' tives 81/851 and 81/852. Moreover, if the must be understood the manufacturer of the medicinal product, the finished product, and not the manufacturer of each constituent. 49 — First paragraph of the French translation of its observa- tions. 50 — Ibid., seventh paragraph, my emphasis. 51 — Under the heading 'Answer to question l b ' on page 9 of 52 — The participating parties are unanimous that this is the case. the Commission's observations. 53 — Point (a) of the first preliminary question.

69. At the hearing, the United Kingdom accepted that these particulars were not men- tioned in Directive 81/851 as being particu- 73. This is clear from the wording of a num- lars which must be appended to applications ber of provisions of those directives. for the grant of a marketing authorisation for a veterinary medical product and that it had requested them in order to be able to get in touch directly with the manufacturers of the 74. Thus, Article 11 of Directive 81/851 p r o - product in question in order to obtain the vides that: 'The authorisation provided for in information about the manufacturing process Article 4 shall he withheld if examination of and control methods for the preparation of the documents and particulars listed in SS which was lacking in Norbrook's applica- Article 5 establishes that: ... . 57 Authorisa- tion documents. It states that point 3 of the tion shall also be withheld if the application first paragraph of Article 9 of Directive documents submitted to the competent 81/851 allows it to demand this further authorities do not comply with Articles 5, 6 information. 55 and 7'. 58

75. Similarly, point 1 of the first paragraph 70. That article provides that the competent of Article 9 of Directive 81/851 provides authority '[may], where appropriate, require that: 'In order to examine the application the applicant to provide further information submitted pursuant to Article [5], the com- as regards the items listed in Article 5'. 56 petent authorities of the Member States: 1. shall check that the documentation submitted in support of the application complies with 54 — Second paragraph of section A of Part 1 of Title I of the Annex to Directive 92/18. 55 — Point 14 of the United Kingdom Government's observa- tions. 57 — Ibid., first paragraph, my emphasis. 56 — My emphasis. 58 — Ibid., second paragraph, my emphasis.

—- withhold, withdraw or suspend market- ing authorisation,

78. Moreover, the interpretation according to which all the requirements of Article 5 of 60 — Third recital of the preamble to the 'standards and proto- Directive 81/851, submitted in accordance cols' directive, my emphasis: 'Whereas standards and pro- with the Annex to Directive 81/852, must be tocols for the performance of tests and trials on veterinary medical products are an effective means of control of these products and, hence, of protecting public health ... .' 61 — Paragraphs 62 to 65 of my Opinion. 62 — Paragraph 21. 59 — My emphasis. 63 — Paragraph 42 of my Opinion.

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— prohibit the supply of a veterinary 83. In my view, allowing the Member States medicinal product or have it withdrawn to demand other information than that pro- from the market, vided for by Article 5 of Directive 81/851 would amount to authorising the competent authorities to substitute the sufficiently pre- cise and unconditional requirements of the directive with other requirements unilater- ally decided upon, with the consequence that there would be a risk of jeopardising the aim of harmonising national procedures for deliv- ery of marketing authorisations for veteri- nary medicinal products, which is a clearly stated aim, 66 and thereby jeopardising the free movement of medicinal products. may be taken on grounds other than those set out in this Directive'. 64

84. The Court has also held that only the matters exhaustively listed by the harmonis- ing directives on marketing authorisation for 81. The wording of that article is clear. It medicinal products for human use may be requires the Member States not to add other required by the competent authority. 67 requirements to those laid down by the directives as regards the grant, withdrawal, refusal and suspension of marketing author- isation.

authorising a Member State to demand par- ing has not complied with the aforemen- ticulars other than those strictly listed by the tioned requirements. 70 aforementioned directives, but only as per- mitting Member States to demand from an applicant for marketing authorisation further information about a particular previously given, in accordance with the provisions of Article 5, where information is judged incomplete with regard to the requirements (1) Refusal to issue marketing authorisation of public health. This would be the case, for example, if, having regard to scientific progress, Member States considered that additional information would be of use for checking the harmlessness and therapeutic effectiveness of a product. 68 Similarly, in my view, it affords them the right, as I will examine below, 69 to suspend a marketing authorisation pending receipt only of par- 88. The national court asks in point (c) of ticulars expressly listed in Article 5. this first question, precisely, whether the provisions of the directives in question allow a competent authority like the VMD to refuse to issue a marketing authorisation for a veterinary medicinal product like Pen & Strep if the person responsible for marketing (Norbrook) has not provided particulars The requirements imposed by Directives about the manufacturer, about the results, 81/851 and 81/852 regarding refusal and sus- with a view to their approval, of control tests pension of marketing authorisations carried out on each batch of starting ma- terial, about the manufacturing process and about the control methods used by the manufacturer of the starting material (SS).

90. When examining those questions, I 94. For the reasons explained above, the emphasised that a competent authority is conclusion must therefore be that a compe- obliged to make grant of marketing author- tent authority cannot refuse to grant market- isation subject to observance of all the condi- ing authorisation for a veterinary medicinal tions listed by Article 5 of Directive 81/851. product either on the ground that particulars A fortiori that authority must refuse to grant of the manufacturer of the product in ques- marketing authorisation for a veterinary tion are missing or on the ground that active medicinal product if one of the items of ingredients have not been obtained from an information required by Article 5 of Direc- approved manufacturer, or on the ground tive 81/851 is missing. that batches of the starting material used in the manufacture of the medicinal product have not been previously approved. On the other hand, it must refuse to grant a market- ing authorisation for the medicinal product if the particulars of the manufacturing process and of the control methods used by the 91. O n the other hand, I have stated that it manufacturer of the starting material are not cannot make the grant of marketing author- contained in the application documents. isation subject to the making available of par- ticulars which are not listed by that provi- sion. Similarly and a fortiori, it cannot refuse to grant marketing authorisation on the ground that documents and information not (2) Suspension of marketing authorisation expressly stipulated by the directives are lacking.

98. Instead of immediately refusing to grant a marketing authorisation to an applicant who has not provided full information, 72 the competent authorities may take the course of 97. As far as the wording of the relevant suspending the authorisation for as long as provisions are concerned: the missing documents have not been appended. 73

The first paragraph of Article 8 of Directive 81/851 provides: 99. The verb 'compléter' means in fact 'to add what is missing' and not 'to add some­ thing else' or 'supply something else'. 74 Thus, in accordance with what I have argued previously, the competent authorities may not demand any information other than that 'Member States shall take all appropriate expressly prescribed by the directive and measures to ensure that the procedure for may suspend the marketing authorisation granting marketing authorisation is com­ only for the reasons it expressly men­ pleted within 120 days after the date of sub­ tioned. 7 5 mission of the application.'

The first paragraph of point 3 of Article 9 100. The ratio legis of the legislation on mar­ provides, as already stated: keting authorisation for veterinary medicinal products is in accordance with that interpre-

71 — My emphasis. 72 — Sec, in particular, paragraph 77 of my Opinion. '[The competent authorities] may, where 73 — Paragraph 86 above. appropriate, require the applicant to provide 74 — In comparison with the French, Italian, Dutch, German and further information as regards the items Spanish versions of the provision, the English version is less precise since it provides: 'may, where appropriate, require listed in Article 5. Where the competent the applicant to provide further information as regards the items listed in Article 5' (my emphasis). authorities take this course of action, the 75 — See, to this effect, the judgment in Pierrel, cited above, para­ time-limits specified in Article 8 shall be graphs 28 and 33.

104. It must be deduced from a reading of 101. It follows from the foregoing that the the account of the method of manufacturing competent authorities have the right to sus- the medicinal product that neither SS nor pend the period for grant of the marketing DHS are made according to a process which authorisation laid down in Article 8 of consists in mixing the constituents: 'The Directive 81/851 for as long as the applicant Applicant produces DHS from SS by has not supplied the information on the "reduction" or "hydrogénation", whereby manufacturing process and on the control the molecular structure of the [product in testing methods for the starting material. question] is altered. This latter process involves the use of a catalyst called sodium borohydride, which contains the element boron. Once the DHS has been produced it is mixed with the other active ingredient [PP], and the non-active ingredients (known 102. On the other hand, and I here refer to as "excipients") to make the final product my arguments concerning the examination of Pen & Strep'. 79 Production by continuous the requirements laid down by Directives process does not therefore occur until after 81/851 and 81/852 concerning the grant of a the manufacture of DHS. marketing authorisation in so far as I per- ceive no difference between the two ques- tions, 78 a competent authority may not sus- pend grant of a marketing authorisation if an item of information not expressly stipulated by Directives 81/851 and 81/852, such as the 105. According to the Court's established identity of the manufacturer and the sites of case-law, 80 where it clearly appears that the manufacture, is missing. interpretation of Community law is not

108. By this question the national court asks for an interpretation of the provisions of The third question Article 40 of Directive 81/851 and whether reasons must be given for the various requests for information made in this case by the VMD as regards the decisions to suspend and refuse marketing authorisation men- tioned in the preliminary questions previ- ously examined. If the answer is in the affir- mative, the Court is asked to state the conditions which must be observed by the competent authority if they are to be 106. If the demands made by the competent regarded as in conformity with the pro- authority are in conformity with the provi- visions of that article. sions of Directives 81/851 and 81/852, the national court asks, by this question, whether those directives contain provisions which would allow the person responsible for marketing to be exempt from providing the items of information and, if so, on what 109. The first paragraph of Article 40 of conditions. Directive 81/851 provides: 'All decisions taken pursuant to Articles 11, 82 36, 83 37 84 and 38, 85 all negative decisions taken pursuant to Article 10, point 2, and Article 19(3) of this Directive and all decisions to withdraw authorisation to manufacture or to import from third countries or to suspend or withdraw manufacturing authorisation shall state in 107. In Scotia Pharmaceuticals, cited above, details the reasons on which they are based. the Court has already had to reply to such a Such decisions shall be notified to the party question concerning marketing authorisation concerned who shall at the same time be for a medicinal product for human use. In informed of the remedies available to him that case the Court held that the tests and under current legislation and the time particulars listed by the directives in force allowed for seeking such remedies.' had to be appended to the application for marketing authorisation and that only scien- tific progress could entail a change in the information to be supplied for the purposes 82 — Provision listing the cases in which marketing authorisation which must be refused. of the grant of marketing authorisation. 81 83 — Provision listing the cases in which marketing authorisation must be suspended or withdrawn. 84 — Provision listing the cases in which marketing authorisation must be withdrawn. 85 — Provision listing the cases in which marketing authorisation 81 — Paragraphs 41 and 49 of my Opinion. must be suspended or withdrawn.

115. In my view, a distinction must be made between such requests, according to whether 112. As regards the obligation to state in or not they are prescribed by Directives detail the reasons for the decisions in ques- 81/851 and 81/852. tion, I consider that reasons which show clearly and unequivocally why a competent authority has refused, withdrawn or sus- pended a marketing authorisation meets the requirements of Article 40. This will be the case, for example, with reasons indicating the 116. If they are not provided for by those particulars and items of information missing. directives (as is the case with requirements

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concerning prior approval of each batch of between several appropriate measures, SS or D H S or of the sites of manufacture of recourse must be had to the least onerous, SS), there are no grounds for them to be and the disadvantages caused must not be made, and any application of the principle of disproportionate to the aims pursued. 86 proportionality will be redundant.

117. O n the other hand, in the case of demands required to be made by those direc- tives, it will indeed be necessary to determine whether those stipulations comply with that 120. The very high level of requirement principle. As far as I know, this is the first imposed by those provisions for the market- time that the Court has been asked to do ing of a veterinary medical product is in con- this. formity with the aim of providing absolute protection for public health pursued by that legislation.

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122. Norbrook claims 88 that the principle of The fifth question: breach of Articles 30 to 36 proportionality has been contravened in that, of the Treaty in particular '... the nature of this require- ment, in particular the frequent impossibility of compliance and the consequences of such non-compliance, is wholly out of proportion to such infinitesimal risk to public health ... which might result from ignorance ... of [SS] manufacturing processes'. 89

125. The national court also asks whether the VMD's demands for information under Directives 81/851 and 81/852 are in breach of Articles 30 to 36 of the Treaty.

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127. In the present case, the medicinal prod- 1996 in the Dillenkofer case 92 the Court uct Pen & Strep does fall within the scope of clearly and precisely reiterated the condi- Directives 81/851 and 81/852. Accordingly, tions under which a Member State incurs its marketing is subject to issue of a market- liability for breach of Community law. ing authorisation by the VMD, which must observe all the legal provisions in force.

128. It must therefore be concluded that 131. The Court has held 93 that individuals there is no factor enabling it to be concluded who have suffered damage have a right to that a breach of Articles 30 to 36 of the reparation where three conditions are met: Treaty has occurred. the rule of Community law infringed must have been intended to confer rights on them; the breach must be sufficiently serious; and there must be a direct causal link between that breach and the damage sustained by the individuals. 94 Answers to the questions concerning the conditions under which a Member State incurs liability for breach of Community law

132. As regards the condition concerning a The seventh question sufficiently serious breach of a rule of Com- munity law, the Court has also held that it is fulfilled 'if ... a Member State, in the exercise of its rule-making powers, manifestly and gravely disregards the limits on those pow- ers' and that 'if, at the time when it commit- ted the infringement, the Member State in 129. Finally, by this question, the Court is question was not called upon to make any asked to make clear the conditions under legislative choices and had only considerably which a Member State incurs liability for reduced, or even no discretion, the mere breach of Community law.

Conclusion

136. In conclusion, for the reasons explained above, I p r o p o s e t h a t t h e questions s u b m i t t e d b y t h e C o u r t of Appeal in N o r t h e r n Ireland s h o u l d b e answered as fol- lows:

(1) C o u n c i l Directive 8 1 / 8 5 1 / E E C of 28 S e p t e m b e r 1981 o n t h e a p p r o x i m a t i o n of t h e laws of t h e M e m b e r States relating t o veterinary medicinal p r o d u c t s a n d C o u n c i l Directive 8 1 / 8 5 2 / E E C of 28 S e p t e m b e r 1981 o n t h e a p p r o x i m a t i o n of t h e laws of t h e M e m b e r States relating t o analytical, p h a r m a c o - t o x i c o l o g i c a l a n d clinical standards a n d p r o t o c o l s in respect of t h e testing of veterinary medicinal p r o d u c t s (and in particular Articles 5, 8, 9, 1 1 , 2 9 t o 3 1 , 35, 40 a n d

95 — Ibid., paragraph 25, my emphasis. 96 — Point 41 of my Opinion.

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(iii) refusing to grant such authorisation if the information referred to in (ii) above is not provided;

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(d) requiring the competent authority to state reasons for any decision refus- ing, suspending or withdrawing marketing authorisation for a veterinary medicinal product. This requirement is satisfied if the decision shows clearly and unequivocally the reasons for which that authority refused, suspended or withdrew such authorisation.

(2) Examination of the provisions of the abovementioned directives, in the light of the grounds of the order for reference, has not revealed any factor of such a kind as to affect their validity.

(3) A Member State is liable for damage suffered by individuals as a result of a breach of Community law for which it can be held responsible if the rule of Community law infringed was intended to confer rights on individuals, the breach is sufficiently serious, and there is a direct causal link between the breach and the damage suffered by the individuals.