Opinion of Advocate General Lenz delivered on 8 March 1994

1 Original language: German.

2 Council Directive 77/62/EEC of 21 December 1976 (OJ 1977 L 13, p. 1), as most recently amended by Council Directive 88/295/EEC of 22 March 1988 (OJ 1988 L 127, p. 1), which pursuant to Article 20 thereof applies to Spain only from 1 March 1992; the whole of the pre-litigation procedure prior to the present proceedings for infringement of the Treaty took place before that date.

3 As amended by the Real Decreto Legislativo No 931/86 of 2 May 1986 (BOE No 114 of 13 May 1986, p. 16920) and the Real Decreto No 2528/86 of 28 November 1986 (BOE No 297 of 12 December 1986, p. 40546) for the purpose of complying with the directives of the European Economic Community.

4 Real Decreto Legislativo No 931/86 and Real Decreto No 2528/86.

5 Judgment in Case C-71/92 Commission v Spain [1993] ECR I-5923.

6 As amended by Decree No 2065/74 of 30 May 1974 on the approval of the consolidated text of the general law on social security (BOE No 174 of 20 July 1974, p. 1482).

7 Reference for a preliminary ruling of 8 May 1989 in Case C-179/89 (OJ 1989 C 160, p. 10).

8 Since 23 May 1989, the Tribunal Superior de Justicia de Andalucía (BOE No 119 of 19 May 1989, p. 14896).

9 Since 1 November 1993, the EC Treaty pursuant to the Treaty on European Union of 7 February 1992 (OJ 1993 C 191, p. 1).

10 Removed from the Register of the Court (see OJ 1989 C 301, p. 7).

11 For the consequences of termination of the infringement of the Treaty before the expiry of the period laid down in the reasoned opinion, see my Opinion of 26 February 1992 in Case C-362/90 Commission v Italy [1992] ECR I-2353, paragraph 10 et seq.

12 See the judgment in Case C-296/92 Commission v Italy [1994] ECR I-1, paragraph 11.

13 See Case C-296/92 Commission v Italy, cited above.

14 P. 2 of the reply.

15 Mainly vaccines.

16 See Article 1(a) of Directive 77/62.

17 See Article 5(l)(a) of Directive 77/62.

18 See Article 20(2) of Directive 88/295.

19 See the second subparagraph of Article 5(l)(a) of Directive 77/62, as amended by Directive 88/295.

20 See p. 5 of the defence; 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); Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (OJ 1975 L 147, p. 1); Second Council Directive 75/319ÆEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ 1975 L 147, p. 13) and the later amending directives: Directive 87/19/EEC (OJ 1987 L 15, p. 31), Directive 87/21/EEC (OJ 1987 L 15, p. 36) and Directive 89/341/EEC (OJ 1989 L 142, p. 11).

21 Council Directive of 21 December 1988 (OJ 1989 L 40, p. 8).

22 See the fifth recital in the preamble to Directive 89/105.

23 Case C-71/92, ibid., paragraph 15.

24 Case C-71/92, ibid., paragraphs 10, 22 and 36.

25 See the second recital in the preamble to Directive 77/62.

26 Article 2(2)(a) of Directive 77/62.

27 Article 2(2)(b) of Directive 77/62.

28 Sec Article 3(a) and (b) of Directive 77/62.

29 See Article 3(c) of Directive 77/62.

30 See Article 4(1) of Directive 77/62.

31 See Article 4(2) of Directive 77/62.

32 With reference to the judgment in Joined Cases 266 and 267/87 The Queen v Royal Pharmaceutical Society of Great Britain, ex parte Association of Pharmaceutical Importers [1989] ECR 1295.

33 With reference to the judgments in Case 102/77 Hoffmann La Roche v Centrafarm [1978] ECR 1139 and in Case 3/78 Centrafarm v American Home Products Corporation [1978] ECR 1823.

34 Emphasis added.

35 See Article 6(l)(b).

36 Open procedures and restricted procedures.

37 Council Directive of 26 July 1971 concerning the coordination of procedures for the award of public works contracts (OJ, English Special Edition 1971 (II), p. 682).

38 See my Opinion of 13 January 1987 in Case 199/85 Commission v Italy [1987] ECR 1039, at p. 1047, paragraph 36; judgment in Case C-24/91 Commission v Spain [1992] ECR I-1989, paragraph 13; judgment in Case C-107/92 Commission v Italy [1993] ECR I-4655, paragraph 12.

39 See paragraph 11 of the judgment in Case C-71/92.

40 See paragraph 18 of the judgment in Case C-71/92.

41 See paragraph 26 of the judgment in Case C-71/92.

42 Likewise the corresponding provisions of the implementing regulation.

43 Sec paragraph 12 of the judgment in Case C-71/92.