Court of Justice of the European Union, Case C-178/20 of 8 July 2021 (Pharma Expressz)

8 juillet 2021 – According to the Hungarian legislation, medicinal products without a marketing authorisation issued by the Hungarian authorities or the European Commission may be placed on the market only where their use for medical purposes is notified to those authorities by a medical practitioner prescribing medicinal products, who must obtain from those authorities a declaration concerning that use. In the following, the Court of Justice of the European Union had to assess whether it was contrary to EU law to require compliance with those formalities for the placing on the market of medicinal products in Hungary which have been granted marketing authorisation by another Member State and which are available without medical prescription in such other state.

After a comprehensive examination, the court held that 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, has granted its marketing authorisation. In the absence of such an authorisation, it may nevertheless be possible to supply that medicinal product where its use meets, in accordance with EU law, special medical needs.

For more information, see here (judgement) and here (press release).