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

(Source: Court of Justice of the EU)

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

In March 2019, the Hungarian authorities ordered Pharma Expressz, a Hungarian company, 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 medicinal products which have been
granted marketing authorisation by another Member State as a medicinal product and which are
available without medical prescription. According to the Hungarian legislation, medicinal products
without a marketing authorisation (‘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 authorisation by
one Member State and which are available without medical prescription.

Full Press Release – 122/2021 : 8 July 2021 – Judgment of the Court of Justice in Case C-178/20

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