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the rule of precedence which it lays down applies where a product satisfies with certainty the conditions for classification as a medicinal product within the meaning of Article 1(2) of Directive 2001/83 as amended, but there is doubt as to whether that product may also fall within other categories of products regulated by EU law;

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by contrast, that rule of precedence does not apply where a product clearly falls within the definition of one of those other categories of regulated products;

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that rule of precedence equally does not apply where it is certain that a product is solely a medicinal product and that it cannot be regarded as a product falling within other categories of products regulated by EU law;

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in the latter case, that directive is applicable to that product by reason simply of the fact that it meets one of the definitions of medicinal product set out in Article 1(2) of that directive and satisfies the conditions laid down in Article 2(1) of that directive.

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it precludes the placing on the market of a product as a food for special medical purposes from being prohibited by the authority competent to enforce the legislation relating to those foods, on the ground that that product does not satisfy the conditions laid down by that legislation, where, first, in the Member State concerned, such an authority is different from the authority competent to enforce the legislation on medicinal products, and, second, that product is a medicinal product by presentation, within the meaning of Article 1(2)(a) of Directive 2001/83 as amended, according to the assessment of the court hearing appeals against the decisions of the authority competent to enforce the legislation relating to those foods;

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in order to ensure the effectiveness of that directive and compliance with the principle of sincere cooperation enshrined in Article 4(3) TEU, that court or authority must, however, inform the authority competent to enforce the legislation on medicinal products without delay that medicinal products by presentation, within the meaning of Article 1(2)(a) of that directive, have been placed on the market, so that it may adopt the measures necessary to protect public health.