Máté Laczkó

Oct 2, 2024 | ceelegalmatters.com | Helga Bíró |Máté Laczkó |Baker McKenzie |Baker McKenzie Budapest

Details 02 October 2024 Hits: 20 Issue 11.7 Typography Smaller Small Medium Big Bigger Default Helvetica Segoe Georgia Times Reading Mode For the pharmaceutical industry in the Hungarian market, the first half of 2024 involved several legislative changes with significant practical implications. Some of these changes have yet to unfold their full impact, due to the lack of implementing regulations and prerequisite authority actions. Below is our review of the most important legal developments,...

Jul 11, 2024 | globalcompliancenews.com | Máté Laczkó

In briefUnder the recently published Act XXIX of 2024 amending certain acts concerning the operation of the State, as of 1 January 2025, certain decisions on named patient reimbursement of medicinal products will be made by a newly created public benefit foundation in addition to the NEAK. Further, starting from 1 January 2026, the operator of the National eHealth Infrastructure (EESZT) may give access to the stored data for the purpose of AI development.

Apr 5, 2024 | globalcompliancenews.com | Máté Laczkó

In briefOn 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. 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.

Mar 11, 2024 | globalcompliancenews.com | Máté Laczkó

Reimbursing medicinal products is critical to ensure that treatments are widely available to patients. This is especially true for innovative products and is expected to become even more important with the EU Pharma reform package. Pricing and reimbursement (P&R) is an area regulated at Member State level, and on average the regulatory approach in Hungary has been on the stricter side for new medicinal products causing delay to market access.

Mar 11, 2024 | globalcompliancenews.com | Máté Laczkó

Author Dr. Máté Laczkó Browsing Mate Laczko is an Associate in Baker McKenzie, Budapest office.