INDUSTRIES, E-COMMERCE – LIFE SCIENCES | The CJEU on the Distance sale of medicinal products

On 21 May 2026, the Court of Justice of the European Union (CJEU) issued its judgment in case C-604/24 (FARMAKEIO YZ & SIA O.E. v Ypourgos Anaptyxis kai Ependyseon and Ypourgos Ygeias) addressing one of the key issues in the European framework governing the distance sale of medicinal products: the scope of the right to sell non-prescription medicinal products online and the limits of the regulatory powers of Member States.

The dispute originated in Greece, where national legislation permitted the distance sale via the internet only of a specific subcategory of medicinal products not subject to medical prescription. The national court therefore asked the Court of Justice whether such a limitation was compatible with Article 85-quarter of Directive (EC) No. 83 of 6 November 2001 (on the Community code relating to medicinal products for human use).

In its decision, the Court of Justice held that Article 85-quater Directive 2001/83 requires Member States to allow the online sale of all medicinal products not subject to medical prescription, providing for a single exception relating to prescription-only medicinal products, and does not authorize Member States to distinguish between different subcategories of non-prescription medicinal products for the purposes of their online marketing. The Court further clarified that the power granted to Member States to adopt measures for the protection of public health concerns solely the conditions governing distance selling and does not permit the introduction of prohibitions excluding certain categories of non-prescription medicinal products from online marketing. Consequently, national legislation allowing online sale only of certain types of OTC medicinal products, while prohibiting it for others, is incompatible with European Union law.

The judgment confirms that EU law does not allow Member States to selectively determine which categories of non-prescription medicinal products may be marketed online and which may not, since such a distinction would be incompatible with Article 85-quater Directive 2001/83/EC. The principle established by the Court is therefore that distance selling constitutes the general rule for all non-prescription medicinal products, whereas any national restrictions may affect only the conditions of sale and not the permissibility of the sale itself.

Newsletter n. 119 – June 2026