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.

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.