Recital 18

(18)Directive 2001/83/EC of the European Parliament and of the Council ¹⁵ applies in cases where a product, taking into account all its characteristics, may fall both within the definition of ‘medicinal product’ as laid down in that Directive and within the definition of a product covered by this Regulation. In that respect, where a Member State establishes in accordance with Directive 2001/83/EC that a product is a medicinal product, it may restrict the placing on the market of that product in accordance with Union law. Moreover, medicinal products are excluded from the definition of food as laid down in Regulation (EC) No 178/2002 and should therefore not fall within the scope of this Regulation.