C-297/94

2. No veterinary medicinal product may be administered to animals unless the authoriza­ 2. The directive was adopted pursuant to tion referred to above has been issued, except Article 100 of the Treaty, and the recitals in for tests of veterinary medicinal products its preamble provide inter alia that the pri­ referred to in point 10 of Article 5.' mary purpose of any rules for, among other things, the distribution of veterinary medici­ nal products must be the safeguarding of public health (first recital). Approximation of the Member States' provisions on veterinary medicinal products is of importance in removing hindrances to trade in medicinal products within the Community (second, 4. The directive also contains highly detailed third and fourth recitals). The directive, rules concerning, inter alia, the conditions however, represents only one stage in the governing applications for authorizations to achievement of the aim of freedom of move­ market veterinary medicinal products, ment of veterinary medicinal products (11th including rules on the documentation and recital). information to be provided, on the process­ ing of such applications and on authoriza­ tions and their renewal. In addition, the directive establishes a Committee for Veteri­ * Original language: Danish. 1 — OJ 1981 L 317, p. 1. nary Medicinal Products in order to facilitate

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OPINION OF MR ELMER — CASE C-297/94

the adoption of a common position by the 3. N o veterinary medicinal product may be Member States with regard to marketing administered to animals unless the authoriza- authorizations. The directive also sets out tion referred to above has been issued, except rules on the manufacture of veterinary for the tests of veterinary medicinal products medicinal products and on the supervision of referred to in point 10 of Article 5 ... products granted marketing authorization, along with sanctions, including withdrawal of marketing authorization, in cases where, inter alia, the product proves to be harmful or lacking in the therapeutic effect claimed.

veterinary practitioners and dispensing substances to the list of active substances chemists, all of whom are established in Bel­ permitted as ingredients in unregistered gium, brought proceedings before the Bel­ medicinal products which could be imported gian Conseil d'État (Council of State) seek- under the rules in the Decree of 14 February ing the annulment of three Royal Decrees of 1990. 20 December 1989, 14 February 1990 and 16 January 1992, which they consider to be contrary to Community law.

The questions submitted for a preliminary ruling

7. According to the judgment making the reference, the first Royal Decree, that of 20 December 1989, provided that it would, from 1 March 1990, no longer be possible to 10. By judgment of 12 October 1994, the import into Belgium veterinary medicinal Belgian Conseil d'État referred the following products that had not been approved by the questions to the Court for a preliminary rul- Belgian authorities. ing:

to veterinary medicinal products, in par- authorized by the competent authorities of ticular Article 4 thereof as replaced by the Member State in question, and whether Council Directive 90/676 of 13 Septem- the provision must therefore be interpreted ber 1990, 3to be interpreted as implying as containing a prohibition of the importa- a prohibition of the administration of a tion of such medicinal products. In what fol- medicinal product without the authori- lows, the questions will be considered zation of the competent authority of a together. Member State and thus a prohibition of the importation of such a product when it is not placed on the market in that Member State and consequently has not previously been authorized by the auth- ority of that Member State and when, in addition, it has not been authorized by Proceedings before the Court of Justice another Member State?'

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BRUYÈRE AND OTHERS ν BELGIAN STATE

prohibition in the directive of marketing and authorization for the product to be mar­ administering unauthorized products also keted. The directive contains a derogation covers the importation of such products. from this rule in so far as Article 4(2) allows certain products to be tested on animals under the conditions set out in point 10 of Article 5. In the amending directive, this der­ ogating rule on the use of unauthorized products for the purpose of tests is retained in Article 4(3); however, Article 4(5) also contains a further derogating rule, under 14. The Commission takes the view that the which veterinarians providing services in national court properly limited its questions another Member State can, 'notwithstanding to the interpretation of the directive in so far paragraph 3', take into and administer in the as the text of the directive clearly addresses host Member State small quantities of prod­ the question of the importation of unautho­ ucts which have not been authorized in the rized medicinal products by veterinary prac­ host Member State, on condition that the titioners. If the main rule in the directive on competent authorities in the Member State the prohibition of marketing and administra­ of establishment have authorized the prod­ tion of unauthorized medicinal products did ucts in question. not also imply a prohibition of the importa­ tion of such medicinal products, it would not have been necessary to implement the dero­ gating provision in Article 4(5), in the ver­ sion resulting from the amending directive, regarding entitlement to import and adminis­ ter such products in connection with veteri­ nary services provided outside the Member State of establishment.

17. As the Commission stresses, the inclu- main rule in the directive on the prohibition sion of Article 4(5) by the amending direc- of marketing and administration of unautho- tive would also have been redundant if it did rized veterinary medicinal products did not not follow from the main rule in the direc- also include prohibition of the importation tive that unauthorized products may not be of such products, it would not in practice be imported or administered in the situations possible to counteract breaches of the rules referred to in Article 4(5). The provision and the Community-law regulation of this expressly features as a (new) derogation from area would thus remain ineffective in practice the general rule in Article 4(3), as evidenced and fail to achieve its objective of protecting by the words 'notwithstanding paragraph 3'. public health. If Article 4(5) — as a derogation from Arti- cle 4(3) — expressly addresses the issue of the conditions under which veterinary prac- titioners providing services in another Mem- ber State can take with them and administer products that are authorized for use in the Member State in which they are established, but not in the host Member State, it must accordingly be assumed and specified that such importation and administration of 19. It must be pointed out in this connection unauthorized products is otherwise prohib- that the national court making the reference ited under the main rule in the first subpara- expressly confined its second question on the graph of Article 4(1) and the first subpara- interpretation of Article 4 of the directive, in graph of Article 4(3), as introduced by the the version resulting from the amending amending directive, which, moreover, corre- directive, to cases in which no authorization sponds closely to the previous wording of had been granted for the marketing of the Article 4(1) and (2) of the directive. product in any Member State. It is in such cases particularly evident that concern for the protection of public health makes it nec- essary to interpret the prohibition of market- ing and administration of unauthorized vet- erinary medicinal products as also including a prohibition of the importation of such products.

(2) The first subparagraph of Article 4(1) of Council Directive 81/851/EEC on the approximation of the laws of the Members States relating to veterinary medicinal products, along with the first subparagraph of Article 4(3), in the version resulting from Council Directive 90/676/EEC of 13 December 1990, must be understood as meaning that each Member State must prohibit the marketing and administration, as well as the importation, of veterinary medic- inal products, the marketing of which has not been the subject of prior autho- rization by the competent authorities of either the Member State in question or of any other Member State.

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