5.5.2012   

EN

Official Journal of the European Union

C 133/20

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?