Italy: The European Union Court of Justice on the prohibition for wholesalers to purchase medicinal products from pharmacies

In brief

In the judgment published on 21 September 2023 (Case C-47/22), the EU Court of Justice ruled on the interpretation of Article 80, first subparagraph, point (b), of the Directive 2001/83/EC establishing that wholesale distributors must obtain their supplies of medicinal products only from persons who are themselves in possession of the distribution license or who are exempt from obtaining such license.


Key takeaways 

The subject matter of the relevant proceeding was the revocation of the wholesale distribution license held by a pharmacy which purchased medicinal products from other pharmacies without a license. The most relevant aspect of the issue concerns was the possibility for a wholesaler distributor to procure medicines from a pharmacy.

On this point, the Court clarified that Article 80 above must be interpreted as meaning that a person holding a wholesale distribution license may not obtain medicinal products from other persons who, under national legislation, are authorized or entitled to supply medicinal products to the public, but who are themselves neither holders of such a distribution license nor exempt from the requirement to obtain such a license. In this regard, the Court also specified that, for the purposes of the above prohibition, it is of no relevance whether the purchase concerns only a minimal quantity, or if the medicinal products thus acquired are intended for resale only to persons authorized or entitled to supply medicinal products to the public or to persons who are themselves holders of a wholesale distribution license.

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