1 By application lodged at the Court Registry on 25 September 1992, the Commission of the European Communities brought an action under Article 169 of the EEC Treaty for a declaration that by subjecting sterile medical supplies originating in other Member States to tests or laboratory analyses already carried out in those Member States, the results of which may be made available to the Belgian authorities, the Kingdom of Belgium has failed to fulfil its obligations under Articles 30 and 36 of the EEC Treaty.
2 In Belgium the marketing of medicinal products is governed inter alia by the Royal Decree of 6 June 1960 on the manufacture, preparation and wholesale distribution of medicinal products and the dispensing thereof (Moniteur Belge of 22 June 1960, p. 4684).
3 Article 15(2) of that Royal Decree provides that medicinal products from other Member States may not be marketed in Belgium until they have been subjected to an examination to show that they are fully in conformity with the laws and regulations of that country.
4 That obligation applies, in particular, to sterile medical supplies, which are defined under Paragraph 1(B)(d) to (g) of Article 1 of the Royal Decree as: "(d) Surgical ligatures, that is to say all sterile thread of whatever sort used in surgery; (e) Sterile dressings, that is to say all absorbent or carded material of whatever sort presented as sterile; (f) Sterile material for injection, perfusion, transfusion or drainage as well as probes and catheters, that is to say all vessels, tubing, drip needles and all objects presented as sterile for use for injection, perfusion, transfusion or drainage, and all material presented as sterile and intended for use in medical and obstetric operations; (g) Material for internal substitution or prosthesis, that is to say any product or equipment of whatever sort except substances of human origin which are intended for long-term or permanent implantation in the body by a surgical procedure".
5 Legal proceedings and administrative measures may be taken against persons not observing the obligation referred to above. Thus, under Article 53 of the Royal Decree, batches of a medicinal product which have not been subjected to the requisite examination must automatically be monitored by an approved laboratory on the occasion of each subsequent importation.
6 The Commission considers that the requirement of an examination of sterile medical supplies upon their entry into Belgium constitutes an obstacle to the free movement of goods, which is not justified by the protection of public health where a similar examination has already been carried out in the Member State of origin and where the results of that examination may be made available to the Belgian authorities.
7 The Belgian Government has not denied the infringement alleged and has stated that a draft Royal Decree seeking to make the abovementioned rules compatible with the Treaty is in preparation.
8 In deciding on this action, it should be recalled that in the absence of comprehensive Community rules in this matter, Member States may adopt measures seeking to ensure that imported products are not capable of adversely affecting public health, provided that the measures adopted are suitable for achieving the objective of protection of health and that that objective cannot be achieved by measures which are less restrictive of intra-Community trade (Case C-62/90 Commission v Germany [1992] ECR I-2575).
9 As the Belgian Government has admitted, the requirement of an examination is superfluous where the imported products have already been subjected in the Member State of origin to an examination similar to that taking place on the national territory and where the results of that examination may be made available to the national authorities.
10 It must therefore be concluded that, by subjecting sterile medical supplies originating in other Member States to tests or laboratory analyses already carried out in those Member States, the results whereof may be made available to the Belgian authorities, the Kingdom of Belgium has failed to fulfil its obligations under Articles 30 and 36 of the EEC Treaty.