1.

How is the expression ‘product covered by other Community legislation’ in Article 2(2) of Directive 2001/83/EC (1) to be interpreted?

Is it the case that only a product

If that question is to be answered in the affirmative:

If that question is to be answered in the negative:

2.

How is the expression ‘in cases of doubt’ in Article 2(2) of Directive 2001/83 to be interpreted?

3.

How is the expression ‘may fall’ in Article 2(2) of Directive 2001/83 to be interpreted? Does that expression ‘may fall’ also cover a product which, clearly or as a result of administrative or judicial proceedings, cannot be classified as a (given) ‘product covered by other Community legislation’?

4a.

To what extent do Article 2(2) of Directive 2001/83 or other provisions of Community law preclude the authority competent to enforce Community legislation concerning a (given) ‘product covered by other Community legislation’ from enforcing applicable Community provisions in respect of that given ‘product covered by other Community legislation’ where that product has been definitively classified as a medicinal product by the medicines agency after carrying out a procedure?

4b.

Must Article 2(2) of Directive 2001/83 or other Community legislation be interpreted as meaning that the national authority is not entitled, in respect of a product

to prohibit the company placing the product on the market from continuing to place that product on the market as that given ‘product covered by other Community legislation’ (on the basis that it has failed to comply with the legal rules applicable to the placing of that product on the market as that given ‘product covered by other Community legislation’)?

5a.

To what extent does Article 2(2) of Directive 2001/83 or other Community legislation prohibit the authority competent to enforce Community legislation concerning a given ‘product covered by other Community legislation’ from enforcing, in respect of that given ‘product covered by other Community legislation’, applicable Community provisions where there are merely grounds to suspect that the product must (also) be classified as a medicinal product and it has therefore not been definitively clarified that the product must be classified as a medicinal product?

5b.

Must Article 2(2) of Directive 2001/83 or other Community legislation be interpreted as meaning that the national authority is not entitled, in respect of a product

to prohibit the company placing the product on the market from continuing to place that product on the market as that given ‘product covered by other Community legislation’ (on the basis that it has failed to comply with the legal rules applicable to the placing of that product on the market as that given ‘product covered by other Community legislation’)?

6.

Does the precedence granted by the Community to legislation on medicinal products (2) also apply where it is certain that a product which must be classified as a medicinal product placed on the market as a given ‘product covered by other Community legislation’ does not satisfy the requirements for classification as that given ‘product covered by other Community legislation’?

7.

How should the scope of the rule that medicinal product legislation is to take precedence laid down in Article 2(2) of Directive 2001/83 be distinguished from the scope of the rule concerning the precedence of medicinal product legislation which stipulates that a negative classification is required, namely that they do not qualify as a medicinal product?