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Spain: Release of new Royal Decree regulating veterinary medicinal products

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In brief

The Spanish Government has approved a new Royal Decree 666/2023, completing the regulatory framework for veterinary medicinal products. This decree seeks to update the regulations governing veterinary medicinal products in accordance with current scientific advances and economic conditions. Among other considerations, it aims to improve the protection of animal health, the environment and the public health. The Royal Decree extends the prescription conditions and the requirements applicable to veterinary professionals, highlighting the conditions of use of antimicrobials. Finally, its main novelties include the regulation of contract warehouses, livestock entities and the issuing of electronic prescriptions.

In more detail

Last 18 July 2023, the new Royal Decree 666/2023 regulating the distribution, prescription, dispensing and use of veterinary medicinal products (“Royal Decree“) was published and entered into force on 21 July 2023. This legislation, together with other previously adopted regulations and in line with Regulation (EU) 2019/6 on veterinary medicinal products, covers the entire regulatory framework for veterinary medicinal products, focusing on industrially produced veterinary medicinal products and veterinary medicinal products manufactured extemporaneously. It repeals the three rules: Royal Decree 109/1995, Royal Decree 544/2016 and Royal Decree 191/2018, which regulated veterinary medicinal products, the distance selling of veterinary medicinal products when not subject to prescription, and the electronic transmission of antibiotic prescription data.

The aim of the new Royal Decree is to adapt the regulation of veterinary medicinal products to the current times. In other words, to ensure that it is in line with the recent scientific advances and the current economic and market conditions. On the one hand, this Royal Decree seeks to improve the focus on the protection of animal health, the environment and the public health. On the other hand, this Royal Decree also introduces a new article on the prudent and responsible use of veterinary medicinal products.

Among the most important aspects of the Royal Decree, new provisions are established with regard to the entities authorized to distribute veterinary medicinal products. New conditions are also established for wholesale, retail and online sales of non-prescription veterinary medicinal products. The Royal Decree also contains new provisions on the obligations of the owners of livestock farms regarding the prudent use of veterinary medicinal products, waste management and the content of its veterinary treatment record book.

The Royal Decree, among other matters:

  • Updates the prescription conditions and requirements that veterinary professionals have to comply when acting in the exercise of their functions
  • Establishes new conditions for the use of antimicrobials, taking into account whether their use in animals poses a relevant level of risk to public health
  • Regulates the requirements for issuing prescriptions through electronic platforms, in addition to the performance of a clinical examination of the state of health of the animals prior to the issuing of a prescription.
  • Establishes new requirements for carrying out treatments involving the use of antimicrobials, including the mandatory notification of these prescriptions to the databases of the Autonomous Communities or to the Central Computer System for the Control of Veterinary Antibiotic Prescriptions
  • Regulates contract warehouses for wholesale distribution for the first time
  • Defines the companies that are classified as livestock entities dedicated to retail sales, in order to establish a harmonized control at national level
  • Regulates the conditions for business-to-consumer (B2C) and business-to-business (B2B) sales made by means of information society services. In particular, it establishes provisions for websites and mobile applications of pharmacies and retail outlets. It also introduces requirements for B2B sales when they involve the exercise of their professional activity as veterinary professionals.

For more information, you can access the full text of the Royal Decree by clicking on this link. You can also contact our expert team in case you require individual advice for your business.

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Author

Elisabet is a Senior Associate experienced Public Law/ Regulatory lawyer in Baker McKenzie's Barcelona office. She has more than 10 years' experience advising heavyweight companies on public law and regulatory issues. Elisabet advises both national and multinational companies on public procurement, administrative compliance, license schemes, environmental, ESG, regulatory, and products-related matters (circular economy and sustainability requirements, green claims, consumer protection issues, etc), including assistance before regulators, authorities, and courts. In addition, she regularly advises private companies on regulatory issues related to business expansion and the opening of new plants/premises. She also advises on litigation and trials related to the areas of specialization. She has extensive experience in the consumer & goods and life sciences sectors. Regarding the life sciences sector, she offers advice to Spanish and foreign life sciences companies and represent them before authorities and courts regarding public procurement issues, price & reimbursement procedures, authorization and registration, promotion and advertising of medicines, and other regulatory issues related to medicinal products, medical devices, cosmetics, food supplements and other foods for particular nutritional uses. She also professor at Pompeu Fabra University, UPF Barcelona School of Management and ESADE Law School in the field of Public Law. She regularly participates in publications and articles related to her specialty.

Author

Damià Triay is an Associate in Baker McKenzie, Barcelona office.

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