Vlajčić: The Veterinary Medicines Act has tightened the rules for antibiotics

Croatia has introduced stricter regulations on the use of veterinary antibiotics as part of a new law aimed at combating antimicrobial resistance. The proposed Law on Veterinary Medicines and Veterinary Medical Products was presented by Minister of Agriculture, Forestry, and Fisheries David Vlajčić (DP) during a session in the Croatian Parliament. According to Vlajčić, this legislation addresses critical issues related to animal health, public health, food safety, and effective measures against antimicrobial resistance.

The law aligns Croatia's regulatory framework with European Union standards and is being enacted under an expedited process to meet the prerequisites for signing an agreement on mutual recognition of quality checks of veterinary medicines between the United States and the European Union. It outlines procedures for approving the production, import, export, and trade of veterinary medicines, placing them on the market, and monitoring their quality and clinical testing. One of the most significant changes involves responsible use of antimicrobial drugs, introducing stricter rules for antibiotic usage and mandating electronic record-keeping and reporting on their application in animals. Additionally, the practice of granting approval for placing veterinary medicines on the market for a limited period of five years is being abolished. Instead, approvals will now be issued indefinitely unless additional checks are required due to ongoing safety monitoring. Internet sales of antibiotics and prescription-only medications are also prohibited.

The Hrvatski Veterinarski Institut (HVI) has been designated as the competent authority for approving medicines alongside the Ministry of Agriculture, the State Inspectorate, and the Agency for Medicines and Medical Products—HALMED. Vlajčić emphasized that even when dealing with exceptional cases requiring specific medications due to disease outbreaks, these situations would still be subject to strict procedures and oversight.

Marijana Petir, President of the Committee on Agriculture, highlighted concerns within the veterinary profession regarding the introduction of a more flexible model for the operation of veterinary pharmacies selling over-the-counter medicines. Under this model, one veterinarian would cover four pharmacies, raising fears among professionals about potential reductions in the number of employed veterinarians. However, she assured that this law would not reduce the availability of veterinary services. Vlajčić noted that the pharmacy model represents a compromise between the demands of the Croatian Employers' Association and the Croatian Veterinary Chamber.

Mario Milinković from the SDP Party welcomed the transfer of some responsibilities to the HVI and positively assessed the requirement that veterinarians coming from other countries must use medicines prescribed in Croatia. He pointed out that the supply of medicines in Croatia is insufficient, despite legal simplifications, which remain largely dependent on the discretion of importers and their economic considerations. He also raised concerns about the coverage of the network of veterinary clinics and pharmacies, particularly on islands, and expressed doubts about the control of internet purchases of over-the-counter medicines, noting that the State Inspectorate lacks a chief state inspector.

Ljubomir Kolarek from the HDZ Party emphasized that this legislative proposal is one of the more important ones. While it might initially appear to concern only veterinarians and the pharmaceutical industry, he stated that the law directly impacts animal health, food safety, environmental protection, and ultimately human health. He underscored that its purpose is not merely compliance with European regulations but also the creation of a modern, transparent, and efficient system for managing veterinary medicines and products.

Tomislav Josić from the DP Party highlighted that this legal solution marks an important step towards modernizing the management system for veterinary medicines and products. The implementation of these new regulations reflects a broader commitment to enhancing public health and ensuring the sustainable use of antibiotics in veterinary medicine. As the law moves forward, it will be crucial to monitor its impact on both the veterinary sector and public health outcomes.