Union Product Database | European Medicines Agency (EMA) (2024)

• Union Product Database: release notes

The Veterinary Medicines information website, the public interface ofthe Union Product Database,enables everyone with an interest in veterinary medicines to:

• search and view information on all authorised veterinary medicines in the EU / EEA, irrespective of the authorisation route;
• find out in which Member State a specific veterinary medicine is available;
• find information which could help identify potential treatment alternatives.

The restricted area of the Union Product Database (UPD) is only accessible to:

• staff of the European Commission;
• national competent authorities;
• marketing authorisation holders.

Registered users can access it via:

• UPD user interface;
• UPD application programming interface (API) machine-to-machine connection.

Find below a registration guide with step-by-step instructions on how to request access to the restricted areas of the UPD user interface and public API:

The registration guide also contains instructions for marketing authorisation holders on how to request access to the UPD via read-only API.

Members of the public and organisations have the two following options to access UPD non-confidential product data:

• Veterinary Medicines information website;
• API (instructions on how to register and request access available in the registration guide).

The implementation guide for the Union Product Database (Version 1) isavailable below.

It contains guidance formarketing authorisation holdersand national competent authoritiesonthe submission of data on veterinarymedicinesto the Union Product Database using standardised data formats and terminologies throughout the EU.

The different chapters of the guide explain thetimelines, requirements, process, technical specification, data elements and associated business rules forsubmitting these data.

The UPD draws on the four SPOR data management services for the centralised management of master data in the EU. For more information, seeSubstance, product, organisation and referential (SPOR) master data.

National competent authorities(NCA)needto submit their legacy product data into the Union Product Database before Regulation (EU) 2019/6 becomes applicable on 28 January 2022.

Legacy product data refers to any data on veterinary medicines authorised in EU Member States before 28 January 2022. Submitting this data is essential forenablingcorrect functioning of the database and other interdependentsystems.

Since July 2021, competent authorities can upload legacy product information into the Union Product Database, using either an application programming interface (API) or a web user interface.

This applies to allveterinary medicinal products authorised in the EU via mutual recognition, decentralised procedure, national procedure or centralised procedure. For more information see:

• Union Product Database: release notes

Guidance on the process and format for submitting legacy data for national competent authorities is available in theimplementation guide for the Union Product Databaseandin aquestion-and-answer(Q&A) document below.

Forquestions not covered by this guidanceNCA staffmaysend a question to the European Medicines Agency.

Marketing authorisation holdersshould submit the followingto theUnion Product Database:

• Volume of sales (VoS);
• Availability status of theproduct;
• Any changes to the authorisation status;
• Variationsnot requiring assessment.

Guidance onsubmitting datais available in chapter sevenof theImplementation guide for the Union Product Databaseandin the question and answerdocument below.

Forquestions not addressed in the guidance, pleasesend a question to the European Medicines Agency.

• UPD refresher webinar for marketing authorisation holders on volume of sales submission
• Union Product Database: Volume of sales webinar for UPD industry users
• Union Product Database: Product grouping and 3rd country product names Webinar for UPD Industry users
• Union Product Database webinar for marketing authorisation holders
• Union Product Database: follow up webinar for marketing authorisation holders
• Union Product Database: webinar on variations not requiring assessment (VNRAs) for marketing authorisation holders

Organisations should make sure that adequatebusiness continuity processesand back-up systems are in place to deal with system failures. This will ensure that any system failures can be resolved within a short period of time and submissions made in atimely manner.

In case of asystem failure of the Union Product Database requiring resolution by EMA, the organisation will be considered compliant with any submission deadlines if they submit as soon as possible after the Union Product Database becomes available again.

For example, marketing authorisation holders have 30 days after implementing a relevant change to submit a variation not requiring assessment into the Union Product Database. Should the systemnot be accessible on the day an organisation wishes to submit a variation not requiring assessment, they should submit within 2 business days after the system becomes available again.

The access policy for the Union Product Database sets out the types of information different user groups willbe allowed to access.

The final access policy is available below together with the outcome of a public consultation.

Ajointcontrollership arrangementdescribes the processing of personal data in the Union Product Database,in accordance with the General Data Protection Regulation and EU Data Protection Regulation.

The joint controllership arrangement describes theroles and responsibilities of EMA and the Member Statesregarding the processing of personal data in the database. It sets out themeasures they must put in place to ensure that personal data in the database is securely processed, and covers how the parties are to handle any personal data breaches.