Hungary: Significant Amendments in Pharmaceutical Regulation

In brief

Recent amendments of Act XCVIII of 2006 („Medicine Economy Act”) have significant impact on medicine and device promotion, interactions with healthcare professionals as well as the pricing and reimbursement of medicinal products. The amendments blur the distinction between promotional and professional/scientific activities and communication which will require assessment of the types of events organized and HCP engagements concluded by pharma companies. The law applies a very low value threshold for costs of organization of events which will significantly hinder companies from organizing any kind of events for HCPs. The amendments were published on 28 June and already entered into force on 29 June requiring fast implementation by companies.


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