Keywords
Summary

Keywords

1. Approximation of laws – Medicinal products for human use – Directive 2001/83 – Scope

(European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 2(2))

2. Approximation of laws – Medicinal products for human use – Directive 2001/83 – Classification of a product as a medicinal product by function – Criteria

(European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 1(2)(b))

3. Approximation of laws – Medicinal products for human use – Directive 2001/83 – Classification of a product as a medicinal product by function – Criteria

(European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 1(2)(b))

Summary

1. Article 2(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, must be interpreted as meaning that Directive 2001/83, as amended, does not apply to a product in respect of which it has not been scientifically established that it is a medicinal product by function, without its being possible to exclude that possibility.

(see para. 29, operative part 1)

2. Article 1(2)(b) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, must be interpreted as meaning that, notwithstanding the amendments made to the definition of a medicinal product by Directive 2004/27, the characteristics of the manner in which a product is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail are still relevant to determining whether that product falls within the definition of a medicinal product by function.

(see paras 35, 37, operative part 2)

3. Article 1(2)(b) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, must be interpreted as meaning that, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, a product cannot be regarded as a medicinal product within the meaning of that provision where, having regard to its composition – including its content in active substances – and if used as intended, it is incapable of appreciably restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action. The capacity to restore, correct or modify physiological functions should not lead to the classification as medicinal products by function of products which, while having an effect on the human body, do not significantly affect the metabolism and thus do not strictly modify the way in which it functions.

(see paras 41, 45, operative part 3)