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The Medicines and Healthcare Products Regulatory Agency considers that neither fluoride added to drinking water nor the resulting fluoridated water is a medicinal product which requires marketing authorisations as medicines.
The case law of the European Court of Justice indicates that it is for the national authorities of each member state, subject to review by the national courts, to determine whether either limb of the definition of the term "medicinal product" is satisfied. In particular, in the European Court of Justice, in the Commissioner of the European Communities v the Federal Republic of Germany [Case C290/90], the Court reviewed precedent and said:
"It is for the national authorities to determine, subject to review by the courts, for each product, whether or not it constitutes a medicinal product, having regard to all its characteristics, in particular its composition, its pharmacological properties as they may be ascertained in the current state of scientific knowledge, the way in which it is used, the extent to which it is sold, its familiarity to consumers and the risks which its use may entail".