Opinion of Mr Advocate General Lenz delivered on 19 February 1991

1 Original language: German.

2 Council Directive 65/65/EEC of 26 January 1965 (OJ English Special Edition J 965-1966, p. 20). Directive 89/341/EEC (OJ 1989 L 142, p. 11) has replaced the term proprietary medicinal product by medicinal product in the title of Directive 65/65; it must be transposed before 1 January 1992.

3 Council Directive 76/768/EEC of 27 July 1976 (OJ 1976 L 262, p. 169).

4 See the judgment in Case 227/82 van Bennekom [1983] ECR 3883, paragraphs 22 and 23.

5 Emphasis added.

6 Case 33/85 Procureur áe la Republique \Timer [1986] FCR I2C7

7 Paragraph 26

8 The grounds for lhe suspension or revocation of the authorization set out in Article II of the directive arc ciosek modelled on the grounds for refusai m Article 5

9 Cf. Article 4(5) and (6) of Directive 65/65.

10 Opinion in Case 227/82 van Bennekom [1983] ECR 3883, at pp. 3908-3910.

11 Cf. the Opinion of Mrs Advocate General Rozes, cued above, p 391Į

12 li is not for the Court of Justice to examine the correctness of that assumption or, therefore, the relevance of the national court's question to the settlement of the case.

13 Or between two pathological states, such as hypertonia and hypotonia.

14 With regard to the classification of pain relievers, just two questions may be cited here. Can pain itself constitute a disease or is it no more than a symptom of a disease? And if the former is true, what and how great a part of the body must be affected and how intense must the pain be in order to speak of a disease?

15 Paragraph 27; emphasis added.

16 Meyers Enzyklopädisches Lexikon, 1978, sub Pharmakologie.

17 See lhe judgment in van Bennekom, cited above, paragraph 35.

18 See paragraph 41 of the van Bennekom judgment; see also Case 35/85 Procureur de la République v Tissier [1986] ECR 1207, paragraph 22, and point 5 of the Opinion of Mr Advocate General Tesauro in Case C-369/88 Delattre [1991] ECR I-1487 at p. I-1511.

19 Like the German text, [he English text of Directive 76/768 differs from that of Directive 65/65 in that it refers to pharmaceuticals rather than medicinal products and to pharmaceutical specialities rather than proprietary medicinal products But that is to be regarded as a mere terminological variation, 1 consider the content of the concepts to be identical in both cases

20 Sec also the clarifications in the fifth clause in the fifth recital in the preamble to Directive 76/768

21 As haj already been stressed, the following considerations, in accordance with the facts of the case, concern only the relationship between Article 1(1) oí Directive 76/768 and ihr second part of the definition of a medicinal product. Other considerations apply to the products listed in Annex I to the directive, to which Article \(2) refers. If a product corresponds to one of the alternatives listed, it is established as being a cosmetic product. That annex is, however, also relevant to the delimitation where the product in issue does noi correspond to any of the alternatives listed in it, thus limning the primacy of the definition of medicinal product to a certain extent in that respect. I shall return to this question (point 77).

22 Src the first recital in the preamble to Directive 65/65 and ihc third recital in the preamble to Directive 76/768.

23 Presented.

24 With a view to.

25 Paragraph 22 of the judgment.

26 See Case 250/84 Eridania v Cassa Conguaglio Zucchero [1986] ECR 117, paragraph 38; consistent case-law since that date.

27 Fourth clause: chis directive is noi applicable to the products that fall under the definition of cosmetic product but are exclusively intended to protect from disease

28 It is established that application to the various external parts of the human body ... or with the teeth and mucous membranes of the oral cavity (Article I) does not cover cases where the producu in question are intended to be ingested, inhaled, injected or implanted in the human body

29 Emphasis added

30 The explanation for that classification seems to be afforded by the substances dissolving hard skin, which are also contained in products for the treatment of corns or acne; for peeling producu, the possible harmful effects of contact with the eyes, which is difficult to prevent even when correctly applied, must apparently also be taken into consideration.

31 Thai expression has, however, a rather wider meaning than lhe criterion of the proper place of application to be borne in mind here. It also covers, in particular, the frequency and duration of the administration.

32 The peeling products mentioned in the second item on the list constitute an exception.

33 See footnote 17.

34 Ninth Commission Directive of 2 February 1987 adapting to technical progress Annexes II, III, IV, V and VI to Council Direcme 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (OJ 1987 L 56, p 20)

35 See also the third recital in the preamble to Directive 65/65.

36 See point 35 above.

37 See (he judgment in 7'usicr, paragraph 27