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Document 62012CN0109
Case C-109/12: Reference for a preliminary ruling from the Korkein hallinto-oikeus (Finland) lodged on 29 February 2012 — Laboratoires Lyocentre
Case C-109/12: Reference for a preliminary ruling from the Korkein hallinto-oikeus (Finland) lodged on 29 February 2012 — Laboratoires Lyocentre
Case C-109/12: Reference for a preliminary ruling from the Korkein hallinto-oikeus (Finland) lodged on 29 February 2012 — Laboratoires Lyocentre
SL C 133, 5.5.2012, p. 20–20
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
- Date of document:
- 29/02/2012
- Date lodged:
- 29/02/2012
- Author:
- Sud
- Form:
- Pravosudna informacija
- Authentic language:
- finski
- Type of procedure:
- Prethodno pitanje
- Link
- Select all documents mentioning this document
- Case affecting:
-
- request for interpretation 31993L0042
- request for interpretation 32001L0083 članak 01 P2PTB)
- Link
|
5.5.2012 |
EN |
Official Journal of the European Union |
C 133/20 |
Reference for a preliminary ruling from the Korkein hallinto-oikeus (Finland) lodged on 29 February 2012 — Laboratoires Lyocentre
(Case C-109/12)
2012/C 133/36
Language of the case: Finnish
Referring court
Korkein hallinto-oikeus
Parties to the main proceedings
Appellant: Laboratoires Lyocentre
Other parties: Lääkealan turvallisuus- ja kehittämiskeskus, Sosiaali- ja terveysalan lupa- ja valvontavirasto
Questions referred
|
1. |
Does a definition given in one Member State in accordance with the Devices Directive 93/42/EEC (1), by which a product is regarded as a healthcare device or accessory in accordance with the Devices Directive and is provided with a CE marking, preclude the competent national authority of another Member State from defining the product concerned, on the basis of its pharmacological, immunological or metabolic effects, as a medicinal product in accordance with Article 1(2)(b) of the Medicinal Products Directive 2001/83/EC? (2) |
|
2. |
If the answer to the previous question is in the negative, can that competent national authority define the product as a medicinal product observing only the procedures under the Medicinal Products Directive 2001/83/EC or is it necessary, prior to initiating procedures under the Medicinal Products Directive to define the product as a medicinal product, to follow the safeguard clause procedure in Article 8 of the Devices Directive or to comply with the provisions of Article 18 concerning an unduly affixed CE marking? |
|
3. |
Does the Medicinal Products Directive 2001/83/EC, the Devices Directive 93/42/EEC or European Union legislation otherwise (including the protection of human health and life and consumer protection) preclude products containing the same substance and having the same functions from being on the market in the same Member State both as medicinal products in accordance with the Medicinal Products Directive 2001/83/EC, requiring a marketing authorisation, and as healthcare devices or accessories in accordance with the Devices Directive 93/42/EEC? |
(1) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ 1993 L 169, p. 1.
(2) 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.
