23.11.2013

Official Journal of the European Union

C 344/22

(Case C-109/12) (<span class="super">1</span>)

(Reference for a preliminary ruling - Approximation of laws - Medical devices - Directive 93/42/EEC - Medicinal products for human use - Directive 2001/83/EC - Right of the competent national authority to classify as a medicinal product for human use a product marketed in another Member State as a medical device bearing a CE marking - Applicable procedure)

2013/C 344/37

Language of the case: Finnish

Referring court

Parties to the main proceedings

Appellant: Laboratoires Lyocentre

Respondents: Lääkealan turvallisuus– ja kehittämiskeskus, Sosiaali– ja terveysalan lupa– ja valvontavirasto

Re:

Request for a preliminary ruling — Korkein hallinto-oikeus — Interpretation of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1) and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ 2004 L 136, p. 34) — Vaginal preparation containing live lactobacilli — Right of the competent national authority to classify as a medicinal product within the meaning of Directive 2001/83, on the basis of its pharmacological, immunological or metabolic effects, a preparation marketed in another Member State as a medical device with a CE marking within the meaning of Directive 93/42 — Applicable procedure

Operative part of the judgment

1.The classification of a product in one Member State as a medical device bearing a CE marking, in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, does not preclude the competent authorities of another Member State from classifying the same product, on the basis of its pharmacological, immunological or metabolic action, as a medicinal product within the meaning of Article 1(2)(b) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006.

2.In order to classify as a medicinal product in accordance with Directive 2001/83, as amended by Regulation No 1901/2006, a product already classified in another Member State as a medical device bearing a CE marking, in accordance with Directive 93/42, as amended by Directive 2007/47, the competent authorities of a Member State must, before applying the classification procedure under Directive 2001/83, as amended by Regulation No 1901/2006, apply the procedure under Article 18 of Directive 93/42, as amended by Directive 2007/47, and, where appropriate, the procedure under Article 8 of Directive 93/42.

3.Within the same Member State, a product which, while not identical to another product classified as a medicinal product, none the less has in common with it an identical substance and the same mode of action, cannot, in principle, be marketed as a medical device in accordance with Directive 93/42, as amended by Directive 2007/47, unless, as a result of another characteristic that is specific to that product and relevant for the purposes of Article 1(2)(a) of Directive 93/42, it must be classified and marketed as a medical device, which is a matter for the referring court to verify.

Language of the case: Finnish

(1) OJ C 133, 5.5.2012