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In Product Regulation & Liability

Hungary: Regulatory authority weighs in on Medical Science Liaison position

by and 3 Mins Read

Pharma companies often employ Medical Science Liaisons (MSLs) in order to provide healthcare professionals (HCPs) with high-quality professional and scientific information that lacks promotional content thereby distinguishing it from the information provided by medical sales representatives.
In a recently published decision, the National Institute of Pharmacy and Nutrition (NIPN) stated that it does not support distinction between professional and promotional communication. This position leaves pharma companies with two options: either to register MSLs with the NIPN as a medical sales representative, or to try to severely restrict the information an MSL may share with HCPs.

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In Product Regulation & Liability

Hungary: Lessons learned from the most recent NIPN decisions

by and 6 Mins Read

In the last month, the Hungarian National Institute of Pharmacy and Nutrition (NIPN) published five new decisions on its website relative to the promotional practices of companies under investigation. The NIPN imposed fines for infringements within the range of HUF 3 million (approx. EUR 7,700) to HUF 31 million (approx. EUR 79,500).

In Austria

European Union: DAC7 Risk Test

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In March 2021, the EU approved new reporting rules in a directive known as DAC7. The directive will require the operators of online platforms for the sale of goods and certain services, to collect, verify and share data on their sellers and their transactions concluded on the online platform. EU member states have until 31 December 2022 to implement DAC7 into national law. Certain platform operators will become a reporting platform and will need to start collecting and verifying data points in compliance with the DAC7 reporting requirements. The collected data points must be reported to the tax authorities of the relevant EU member state annually.

In Europe

Hungary: Significant Amendments in Pharmaceutical Regulation

by 1 Min Read

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.

In Europe

Hungary: The Hungarian Regulatory Authority published new decisions on the promotional activities of pharmaceutical companies

by 5 Mins Read

In brief The National Institute of Pharmacy and Nutrition (“OGYÉI”) has issued new decisions on its webpage concerning pharmaceutical promotional activities and interactions with HCPs in which the commercial practices of two pharmaceutical companies were investigated and fines were imposed due to alleged infringements. The key findings of the decisions…

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