CJEU Judgement on OTC Medicines

Recommendation

13/14 December 2023

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In a recently published ruling, the Court of Justice of the European Union (CJEU) in Luxembourg decided that a medicinal product not subject to medical prescription in one Member State may not automatically be placed on the market in another Member State (Case C-178/20, Judgment ECLI:EU:C:2021:551).

A press release published by the CJEU states: "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."

The reason for the proceedings was a legal dispute pending in Hungary. The Hungarian authorities ordered Pharma Expressz, a Hungarian company, to stop its practice consisting in placing medicinal products on the market in Hungary without complying with the formalities laid down in Hungarian law in that regard. 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.

Pharma Expressz brought an action against the Hungarian authority's decision. The company argued that the competent authority's interpretation of Hungarian law amounted to a quantitative import restriction that was incompatible with EU law.

The competent Hungarian court turned to the CJEU in a reference for a preliminary ruling 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.

The CJEU now clarified in its ruling that pursuant to the Medicines Directive, no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State or, under the centralised procedure established to that end, by the Commission. Otherwise, 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.

The case now goes back to the Hungarian court, which has to finally decide the dispute in accordance with the CJEU ruling.

The full text of the judgment is available on the CJEU's legal information system, the Curia website.