Hungary: New law on stockpiling obligation of medicinal products

In brief

On 11 March 2024, Minister of Interior Decree No. 16/2024 (III. 11) on the issuance of the list of strategic medicinal products ("Decree") was published. The Decree introduces a new stockpiling obligation on medicinal product wholesale license holders.


Contents

Key takeaways

  • The list of strategic medicines: Annex No. 1 of the Decree defines the list of active substances of strategic medicinal products necessary for ensuring safe patient care in Hungary. The list currently includes 313 active substances ("Strategic Medicines List").
  • Stockpiling obligation: The Decree imposes a stockpiling obligation on wholesale licence holders that distribute medicinal products containing the active substances included in the Strategic Medicines List. Wholesale license holders must maintain a continuous stock of the concerned products equaling to 1/12th of the volume distributed during the preceding 12 months. The National Center for Public Health and Pharmacy ("NNGYK") will publish on its website the list of medicinal products marketed in Hungary that contain the active ingredients on the Strategic List of Medicines. The NNGYK will review this publication every six months and amend it if necessary.
  • Entry into force: The Decree shall enter into force 60 days after its publication, i.e., on 10 May 2024.
  • Legal consequences: The Decree does not provide for specific legal consequences in case of breach of the stockpiling obligation, however, since the Decree was adopted on the basis of an authorization set out in Act XCV of 2005 on Medicinal Products for Human Use ("Medicines Act"), in case of breach of the stockpiling obligation, the legal consequences of the Medicines Act apply, which could even result in a substantial administrative fine.
Contact Information
Helga Biro
Partner at BakerMcKenzie
Budapest
Read my Bio
helga.biro@bakermckenzie.com
Mate Laczko
Associate at BakerMcKenzie
Budapest
Read my Bio
mate.laczko@bakermckenzie.com

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.