Hungary tightens veterinary medicines rules: key changes for wholesalers

Hungary has amended FVM Decree 128/2009. (X. 6.), the Veterinary Products Decree, which is the main national regulation for veterinary medicinal products to fight antimicrobial resistance and align national rules with Regulation (EU) 2019/6 on veterinary medicinal products. Most of the amendments have been in force since 29 September 2026: wholesalers can no longer supply vets and clinics directly, and non-prescription products may now be sold online. Stricter antibiotic reporting and prescribing rules for companion animals will follow in 2028 and 2029.

End of direct wholesale supply

Wholesalers could previously sell directly to veterinarians, veterinary surgeries, clinics and animal hospitals for their own use. This exception has been abolished, and wholesalers may now supply veterinary products only to other wholesalers or to retailers. Before dispensing veterinary products, the wholesaler must obtain a copy of the buyer’s valid wholesale or retail licence and store it at the place of dispatch for five years. According to the government, the change will make official inspections easier and help manage distribution risks.

Responsible person rules

Each wholesale site still must have a responsible person who oversees its quality system, but a qualified deputy who meets the same criteria may now substitute for them. The list of acceptable university degrees has been broadened and includes medicine, chemistry, pharmaceutical chemistry and technology and biology, alongside the previously recognised fields of pharmacy and veterinary medicine. The responsible person must also have at least one year of quality assurance experience in medicines wholesale. While on-site presence throughout operating hours has always been mandatory, the responsible person previously had to fulfil this. Now, however, either the responsible person or a qualified deputy must be present on site at all times while the site is operating.

Online sales of non-prescription products

The amendments introduce a national framework for distance selling, in line with Regulation (EU) 2019/6. Only non-prescription veterinary medicinal products may be sold online and the distance selling of prescription-only products remains prohibited, despite earlier drafts of the amending decree indicating otherwise.

Online sales may be carried out only from a shop that holds an operating licence and is located in Hungary, or from a public pharmacy, and only once the retailer or pharmacy operator has notified the National Food Chain Safety Office (NÉBIH) of its intention to sell online and has registered. The notification must include the seller’s name, registered office, site and website address. NÉBIH keeps an up-to-date list of authorised online sellers and their websites, and each seller must display on its website the EU common logo referred to in Article 104(6) of Regulation (EU) 2019/6, hyperlinked to that list.

When distributing and delivering products at a distance, sellers must comply with the quality assurance requirements of Chapter II of Annex 8 to the decree, including proper storage conditions. If NÉBIH finds that a seller has breached the distance selling rules, it will remove the seller from its register and from the public list.

Wholesalers already report sales of antibiotics for food-producing animals to NÉBIH. From 1 January 2028, they must also report sales of antibiotics for dogs and cats, and vets must submit aggregated monthly usage data by the 15th of the following month. This prepares Hungary for EU reporting duties that start in 2030. In addition, antibiotics for food-producing animals may only be prescribed by vets that complete a NÉBIH training and receive an official certificate, which is valid for ten years. From 1 January 2029, this requirement will also apply to companion animals and may affect prescribing volumes.

Other changes

The amended Veterinary Products Decree also includes the following changes:

• The mandatory content of prescriptions has been aligned with EU rules. Each prescription may cover only one product, which may be dispensed only once based on that prescription, and is generally valid for 90 days.
• The registrations of ‘other medicinal products’ (egyéb gyógyhatású készítmények), a Hungarian category of non-medicine health products, no longer require renewal every five years and remain valid until withdrawn.
• Animal blood products may be produced or distributed only by vets or entities employing vets and released only with an order form. According to the new rules, a licence to produce animal blood products and a marketing authorisation are needed only if the product is released onto the market.

Next steps

Since the wholesale restrictions and responsible-person requirements are already in force, wholesalers should carry out a compliance check now. They should stop direct supplies to vets and clinics, obtain licence copies from customers before supply and confirm that a qualified responsible person or deputy is on site at all times.

Manufacturers and marketing authorisation holders should review their distribution agreements to ensure that supply runs only through licensed wholesalers and retailers, check that online partners are registered with NÉBIH and prepare for companion-animal antibiotic reporting from 2028.

For more information on how the amendments could affect your Hungary-based business, contact your CMS client partner or the local CMS experts who authored this article.

The article was co-authored by Lili Benyovszki.