Understanding the Union Product Database (UPD)

Regulation EU 2019/6

Implemented on 28 January 2022, the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) updated the rules on the authorization and use of veterinary medicines in the European Union (EU) and replaced Directive 2001/82/EC.

This regulation aims to enhance the availability and safety of veterinary medicines and strengthen EU action against antimicrobial resistance.

The key objectives of the Regulation are:

• Simplify the regulatory environment and reduce administrative burden for pharmaceutical companies developing veterinary medicines, for example through streamlined pharmacovigilance rules.
• Stimulate the development of innovative veterinary medicines, including products for small markets (veterinary limited markets)
• Improve the internal market for veterinary medicines.
• Strengthen EU action to fight antimicrobial resistance through specific measures ensuring prudent and responsible use of antimicrobials in animals, including reserving certain antimicrobials for the treatment of infections in people.

The key benefits of Regulation EU 2019/6

•  Enhanced Access to Medicines: Veterinarians, farmers, and pet owners now have increased access to safe and high-quality medicines for treating and preventing animal diseases.
• Reduced administrative burden and better incentives for pharmaceutical companies developing new and innovative veterinary medicines, benefiting in particular micro, small, and medium-sized enterprises (SMEs).
• New and enhanced rules to keep antimicrobials (including antibiotics) effective based on a “One Health” approach for the benefit of animal and public health and every EU citizen.

Union Product Database (UPD)

The UPD serves as a centralized repository of information on all authorized veterinary medicines in the EU and European Economic Area (EEA) Member States.

Developed and maintained by the European Medicines Agency (EMA), the UPD facilitates easy access to information for various stakeholders.

The public interface of the Union Product Database (Veterinary Medicines information website) enables anyone with an interest in veterinary medicines to:

• Search and view information on all authorized veterinary medicines in the EU / EEA, irrespective of the authorization route.
• Find out in which Member State a specific veterinary medicine is available.
• Find information that could help identify potential treatment alternatives.

For marketing authorization holders (MAHs), the Union Product Database provides self-service access for specific regulatory activities:

• Volume of sales (VoS): MAHs of veterinary medicines are required to submit annual volume of sales data for each of their products to the UPD.
• Availability status of the product: UPD is aimed at enhancing the single market by providing information on veterinary medicinal products available in Member States and allowing health professionals to obtain information on veterinary medicinal products that might be considered as a potential treatment alternative where no suitable veterinary medicinal product is authorized in their Member State.
• Any changes to the authorization status
• Variations not requiring assessment: VNRAs must be recorded by the MAH in the Union Product Database (UPD) within 30 days following implementation.

The latest UPD updates?

On March 28^th, 2024, a new revision of the Best Practice Guide for Variations Not Requiring Assessment was released (EMA/CMDv/308754/2020 - Rev.5) and new details on how to submit grouped VNRA and supergrouping VNRA are described within.

Additionally, regulatory authorities are working on correcting errors observed by the EMA, and EUTCT codes have been updated within the UPD.

Navigating administrative challenges

The Union Product Database (UPD) serves as a single source of information on all authorized veterinary medicines and their availability in the European Union (EU) and European Economic Area (EEA) Member States. The European Medicines Agency (EMA) set up and maintains the veterinary medicines information website and the Union Product Database, in collaboration with the Member States and the European Commission.

Further reading:

https://eureg.ie/the-new-veterinary-regulation-regulation-2019-6-and-its-implications-on-regulatory-submissions-for-veterinary-medicinal-products/

https://animalhealtheurope.eu/about-us/annual-reports/2023-2/two-years-into-the-new-veterinary-medicines-rules-for-the-eu-a-reflection-on-where-we-are-now-2/

https://www.ema.europa.eu/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation/union-product-database

Agnès Oliveras is Manager of Regulatory Affairs at G&L and is based in our Barcelona office.