26.5.2007   

EN

Official Journal of the European Union

C 117/15

1.

Does the rule of doubt in Article 2(2) of Directive 2001/83/EC (1) in the version of Directive 2004/27/EC (2) mean that Directive 2001/83/EC applies to a product which could possibly be classified as a medicinal product but whose quality of a medicinal product has not been positively determined? What degree of probability and hence what degree of elucidation of the facts may be required in order to justify the application of Directive 2001/83/EC?

2.

Can a product which is not a presentational medicinal product be regarded as a functional medicinal product within the meaning of Article 1(2) of Directive 2001/83/EC in the version of Directive 2004/27/EC because of a component which can produce physiological changes in a certain dosage but whose dosage in the product to be assessed — if used as intended — is too low for that? Is this question to be allocated to the criterion of ‘pharmacological action ’or the criterion of ‘modifying physiological functions in human beings’?

3.

Are the characteristics of ‘the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail ’(judgment in Case C-211/03 [2005] ECR I-5141, paragraph 51) stated in the case-law of the Court of Justice to be relevant, in addition to the pharmacological qualities, to classification as a medicinal product still relevant following the new definition of a medicinal product introduced by Directive 2004/27/EC?