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Major Legislative Changes in Hungary's Pharma and Food Industry

Major Legislative Changes in Hungary's Pharma and Food Industry

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Significant legal changes occurred in the Hungarian pharmaceutical and food industry in the summer of 2023. According to Government Decree No. 333/2023. (VII. 20.), as of 1 August 2023, the National Public Health Centre (NNK) and the National Institute of Pharmacy and Nutrition (OGYÉI) merged, establishing a new authority, the National Centre for Public Health and Pharmacy (Nemzeti Nepegeszsegugyi es Gyogyszereszeti Kozpont, NNGYK).

The NNGYK is a central budgetary body operating as a central office under the minister responsible for healthcare (currently the Minister of the Interior, Sándor Pintér) led by the chief medical officer, Cecília Müller. The Government Decree also appoints the NNGYK as the governmental body for pharmaceuticals.

The NNGYK is the legal successor of the NNK and OGYEI. Among its most important tasks are public health, epidemiology, health promotion, healthcare administration and coordination, occupational health, drug policy and activities in the fields of pharmacy, medical devices, food and cosmetics. The legislator expects increased efficiency and faster approval for specialised healthcare and pharmaceuticals through the merger of the NNK and the OGYEI, as the two organisations often worked together in various regulatory procedures. In addition, risk assessments following the placement on the market of food supplements, as well as any possible public health procedures related to them, may become more efficient after the merger.

In another important legislative change, Act XLVI of 2008 on the food supply chain and on the control and supervision of the food supply chain was amended as of 7 July 2023. According to the recent amendment, food supplements that do not comply with the conditions specified in the decree of the Minister of the Interior can only be sold in pharmacies or in stores that meet the conditions specified in the ministerial decree. The Minister of the Interior's decree is currently being prepared.

According to the justification of the amendment, the various substances and plant parts used in the food supplements are not subject to prior control regarding their dosage, effects and side effects before being put into circulation, and anyone can purchase and use them. Lately there has been a rapid increase in the market for food supplement products, and consumers are turning to over-the-counter products. As a result, consumers can buy food supplement products in supermarkets, drugstores, webshops and the like without any professional control, increasing the risk of overdose or of different food supplement products being combined, which can lead to unwanted and harmful health effects.

With the amendment, the legislator aimed to ensure that appropriate expertise is available during the sales process so that consumers can be informed about product-related risks. Pharmacists or pharmacy assistants, as well as trained salespersons, can provide information as well as assistance, and can suggest complete treatment options for consumers. This measure also enhances patient safety. Consequently, instead of stores or webshops with potentially uncertain backgrounds, food supplements with high active ingredient content will be sold in reliable, regularly monitored pharmacies or stores. Thus, the amendment is expected to fundamentally reshape the food supplement market in Hungary.

By Daniel Gera, Office Managing Partner, and Akos Kovacs, Associate, Schoenherr

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