EU Court of Justice judgment in Case C-178/20 Pharma Expressz

In March 2019, the Hungarian authorities ordered local drugmaker Pharma Expressz to stop its practice consisting in placing on the market in Hungary, without complying with the formalities laid down in Hungarian law in that regard, of medicines which have been granted marketing authorization by another European Union member state as a medicinal product and which are available without medical prescription.

According to the Hungarian legislation, medicinal products without a marketing authorization (MA) 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.

Pharma Expressz disputes that decision of the Hungarian authorities before the Fővárosi Törvényszék (Budapest High Court, Hungary), which requests the Court of Justice to clarify whether it is not contrary to EU law to require compliance with those formalities for the placing on the market, in Hungary, of medicinal products which have been granted marketing authorization by one member state and which are available without medical prescription.