International
Asia Pacific
EMEA
North America
Latin America
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.
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.
Copyright © 2024 Baker & McKenzie. All rights reserved. Ownership: This documentation and content (Content) is a proprietary resource owned exclusively by Baker McKenzie (meaning Baker & McKenzie International and its member firms). The Content is protected under international copyright conventions. Use of this Content does not of itself create a contractual relationship, nor any attorney/client relationship, between Baker McKenzie and any person. Non-reliance and exclusion: All Content is for informational purposes only and may not reflect the most current legal and regulatory developments. All summaries of the laws, regulations and practice are subject to change. The Content is not offered as legal or professional advice for any specific matter. It is not intended to be a substitute for reference to (and compliance with) the detailed provisions of applicable laws, rules, regulations or forms. Legal advice should always be sought before taking any action or refraining from taking any action based on any Content. Baker McKenzie and the editors and the contributing authors do not guarantee the accuracy of the Content and expressly disclaim any and all liability to any person in respect of the consequences of anything done or permitted to be done or omitted to be done wholly or partly in reliance upon the whole or any part of the Content. The Content may contain links to external websites and external websites may link to the Content. Baker McKenzie is not responsible for the content or operation of any such external sites and disclaims all liability, howsoever occurring, in respect of the content or operation of any such external websites. Attorney Advertising: This Content may qualify as “Attorney Advertising” requiring notice in some jurisdictions. To the extent that this Content may qualify as Attorney Advertising, PRIOR RESULTS DO NOT GUARANTEE A SIMILAR OUTCOME. Reproduction: Reproduction of reasonable portions of the Content is permitted provided that (i) such reproductions are made available free of charge and for non-commercial purposes, (ii) such reproductions are properly attributed to Baker McKenzie, (iii) the portion of the Content being reproduced is not altered or made available in a manner that modifies the Content or presents the Content being reproduced in a false light and (iv) notice is made to the disclaimers included on the Content. The permission to re-copy does not allow for incorporation of any substantial portion of the Content in any work or publication, whether in hard copy, electronic or any other form or for commercial purposes.
Are you sure want to delete comment ?
Scan this QR Code to share this content
