Opinion of Advocate General Van Gerven delivered on 13 March 1992

1 Original language: Dutch.

2 The four eye lotions at issue are as follows: solution pour lavage oculaire au chlorure de sodium, solution fixatrice d'acides au bicarbonate de soude, solution fixatrice de bases à la glycine et au méthyle-4-hydroxybenzoate de sodium and solution Previn fixatrice d'acides et de bases (glycine, acide éthyldiamintetra acétique, citrate trisodique, acide éth-Íldiamintetra acétique, sodium monosodique et méthyle-4-ydroxybenzoate de sodium).

3 Directive 65/65/EEC of the Council 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), as most recently amended by Council Directive 89/341/EEC of 3 May 1989 (OJ 1989 L 142, p. 11). The latter directive had to be implemented only by 1 January 1992. Accordingly, it is not relevant to this case since the time limit set in the reasoned opinion delivered in this case expired on 8 March 1990 (see in that connection the Court's judgment in Case C-200/88 Commission v Greece [1990] ECR I-4299, paragraph 19).

4 See footnote 2.

5 Apparently, it is not disputed that the eye lotions in question are ready prepared and are placed on the market under a special name and in a special pack. As is clear from footnote 1, however, only one of the four eye lotions, namely the fourth, is referred to by name (Previn). The other three are referred to by reference to their composition.

6 The meaning of substance is more closely defined in Article 1(3) of the directive.

7 See, for instance, the judgment in Case C-112/89 The Upjohn Company and NV Upjohn v Farzoo and Kortmann [1991] ECR I-1703, paragraph 15, the judgment in Case C-369/88 Delattre [1991] ECR I-1487, paragraph 15, and the judgment in Case C-60/89 Monuil and Samanni [1991] ECR I-1547, paragraph 11.

8 See, for instance, the aforesaid judgment in Upjohn, paragraph 16 (with regard to the definition relating to presentation) and paragraph 21 (with regard to the functional definition) and the judgment in Case 35/85 Procureur de la Republique v Tissier [1986] ECR 1207, paragraph 26.

9 See the judgment in Case 227/82 Van Bennekom [1983] ECR 3883, paragraph 17. See also the judgment in Upjohn, cited above, paragraph 16.

10 See the judgment in Monteü and Samanni, cited in footnote 6, paragraph 30.

11 See, for instance, the judgment in Van Bennekom, cited in footnote 8, paragraph 22.

12 Ibid., paragraph 18.

13 Ibid., paragraph 19.

14 See the judgments in Monteil and Samanni and Delattre, cited in footnote 6, paragraphs 24 and 40 respectively.

15 See the judgment in Delattre, cited in footnote 6, paragraph 41.

16 See the judgment in Van Bennekom, cited in footnote 8, paragraph 19, and the judgment in DeUttre, cited in footnote 6, paragraph 38.

17 See the judgment in Upjohn, cited in footnote 6, paragraph 17.

18 Ibid., paragraph 21.

19 Ibid-, paragraph 22.

20 Ibid., paragraph 23, and the judgment in Monteil and Samanni, cited in footnote 6, paragraph 30.

21 See the judgments in Delattre and Monteil and Samanni, cited in footnote 6, paragraphs 26 to 29.

22 See, for instance, the judgment in Case 97/81 Commission v Netherlands [1982] ECR 1819, paragraph 6, the judgment in Case 323/87 Commission v Italy [1989] ECR 2275, paragraph 19, and the judgment in Case 290/87 in Commission v Netherlands [1989] ECR 3083, paragraph 11.

23 See the judgment in Defottre, cited in footnote 6, paragraph 32.

24 See the definitive version (January 1991) of the heading Solutiones Ophthalmicae in the European Pharmacopoeia, Annex II attached to the rejoinder.

25 See the judgment in Delattre-, cited in footnote 6, paragraph 32. See also paragraph 5 above.

26 Slansky H. et al, Prevention of Corneal Ulcers, Tr. Am. Acad. Ophth. OtoL Vol. 75, (Nov-Dec 1971) p. 1208.

27 At the hearing the Commission belatedly referred to a study carried out by a French institution, which postdates the Court's judgment in Upjohn and consequently the expiry of the period material to this case (see footnote 2).

28 It is not clear from the documents before the Court precisely what requirements other Member States impose for the marketing of eye lotions. The scant data provided by the Commission in that regard were contested by the German Government at the hearing.

29 See the judgment in Van Bennekom, cited in footnote 8, paragraph 18.

30 See the judgment in Tissier, cited in footnote 7, paragraph 22, and the judgment in Monteil and Samanni, cited in footnote 6, paragraph 36.