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Veterinary Medicines information website
The Veterinary Medicines information website, the public interface of the 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.
For marketing authorisation holders (MAHs), the Union Product Database provides self-service access for specific regulatory activities, including the management of variations that do not require assessment. It will also enable and simplify several regulatory procedures. For more information, see:
- Union Product Database (accessible to national competent authorities and marketing authorisation holders)
Delivery of the Union Product Database is required by the Veterinary Medicines Regulation (Regulation (EU) 2019/6), which became applicable on 28 January 2022. For more information, seeVeterinary Medicines Regulation.
How to register
Guidance on registering for access to the restricted area of the Union Product Database (UPD) for staff of the European Commission, national competent authorities and marketing authorisation holders is available below.
Implementation guide
The implementation guide for the Union Product Database (Version 1) is available below.
It contains guidance for marketing authorisation holders and national competent authorities on the submission of data on veterinary medicines to the Union Product Database using standardised data formats and terminologies throughout the EU.
The different chapters of the guide explain the timelines, requirements, process, technical specification, data elements and associated business rules for submitting 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, see Substance, product, organisation and referential (SPOR) master data.
National competent authorities(NCA) need to 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 for enabling correct functioning of the database and other interdependent systems.
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 all veterinary medicinal products authorised in the EU via mutual recognition, decentralised procedure, national procedure or centralised procedure. For more information see:
Guidance on the process and format for submitting legacy data for national competent authorities is available in the implementation guide for the Union Product Database and in a question-and-answer (Q&A) document below.
For questions not covered by this guidance NCA staff may send a question to the European Medicines Agency.
For information on how to update package information, please see the following document:
Marketing authorisation holders should submit the following to the Union Product Database:
- Volume of sales (VoS);
- Availability status of the product;
- Any changes to the authorisation status;
- Variations not requiring assessment.
Update: The deadline for submitting volume of sales data in 2023 is 29 February 2024. |
Guidance on submitting data is available in chapter seven of the Implementation guide for the Union Product Database and in the question and answer document below.
For questions not addressed in the guidance, please send a question to the European Medicines Agency.
Webinars and training activities
- 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
Video tutorials
- How to upload document
- How to create/update product - Ingredient section
- How to upload documents via UI
- How to create product from existing one
- How to fill 'Veterinary medicinal product’ section for NAPs
- How to fill 'Regulatory entitlement' section for NAPs
- How to fill 'pharmaceutical product' section for NAPs
- How to fill 'manufactured item' and 'packaged medicinal product” sections
- How to add a new CMS
- How to update product data
- How to approve/reject VNRAs code A.1.a
- How to approve/reject VNRAs code A.4 (ATCvet code)
- How to approve/reject VNRAs code C.1 and C.5 (QPPV and PSMF information)
- How to approve/reject VNRA codes A1a C10a C10c
- How to view volume of sales
- How to view and approve/reject VNRA Supergrouping submissions (NCAs)(updated on 14/03/2024)
- Identifying pending VNRA submissions (updated on 14/03/2024)
- How to save and resume draft submissions
- How to create a pet product (NCAs section)
- Searching for products via Procedure number
- How to submit a VNRA
- How to submit VNRAs code A.1.a
- How to submit VNRAs code A.4 (ATCvet code)
- How to submit VNRAs code C.1 (QPPV information)
- How to submit VNRAs code C.5 and C.6 (PSMF information)
- How to submit VNRA Supergrouping (MAHs) (updated on 14/03/2024)
- How to view VNRAs submissions
- How to download List of Packages
- How to submit volume of sales
- Product grouping
- How to validate CSV files for volume of sales
- How to manage third country product names
- Searching for products via Procedure number
What to do in case of system failure
Organisations should make sure that adequate business continuity processes and 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 a timely manner.
In case of a system 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 system not 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.
Access policy
The access policy for the Union Product Database sets out the types of information different user groups will be allowed to access.
The final access policy is available below together with the outcome of a public consultation.
Processing of personal data
A joint controllership arrangement describes 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 the roles and responsibilities of EMA and the Member States regarding the processing of personal data in the database. It sets out the measures 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.