23‘[P]roduct’ is defined in Article 1(b) of Regulation No 469/2009 as ‘the active ingredient or combination of active ingredients of a medicinal product’. However, the term ‘active ingredient’ is not defined in that regulation. That term also appeared in Article 1(b) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ 1992 L 182, p. 1), which was repealed by Regulation No 469/2009, and a question relating to that provision has already been referred to the Court. The Court held on that occasion that it is generally accepted in pharmacology that the term ‘active ingredient’ does not cover substances forming part of a medicinal product which do not have an effect of their own on the human or animal body (see judgment in Massachusetts Institute of Technology, EU:C:2006:291, paragraph 18).
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