A medicinal product not subject to medical prescription in one Member State may not be placed on the market in another Member State unless that Member State, too, or the European Commission, has granted its marketing authorisation, the Court of Justice of the European Union recalled in a judgment handed down on Thursday 8 July (case C-178/20).
The Hungarian company Pharma Expressz is challenging, in the Hungarian courts, the prohibition on continuing to market in Hungary, without complying with the formalities laid down in national law, medicinal products authorised by another Member State as non-prescription medicinal products.
The Court of Justice of the European Union, acting on behalf of the Budapest-Capital Court, interpreted the ‘Medicines’ Directive (2001/83/EC) and ruled in favour of the Hungarian authorities. It recalls that if a medicinal product does not have a marketing authorisation (MA) issued by the competent authority of the Member State in which it is offered for sale or a MA issued by the European Commission following the centralised procedure, it may not be placed on the market in that State, regardless of whether that same medicinal product may be sold in another Member State without a medical prescription.
Hungarian regulations require that medicinal products without a MA issued by the national authorities or the European Commission may be placed on the market only if their use for medical purposes is notified to these authorities by a prescribing physician, who must obtain a declaration of such use from them. A procedure that Pharma Expressz did not follow.
According to the Court, these formalities constitute the correct transposition of a derogation provided for in the ‘Medicines Directive’. Therefore, in its view, they cannot be qualified as quantitative import restrictions or measures having equivalent effect with regard to the principle of free movement of goods.
See the judgment: https://bit.ly/3xsS139 (Original version in French by Mathieu Bion)