Functionality ID Functionality Functionality Description

1. New Product Data

1.1 Create new veterinary medicinal product entry The relevant competent authority or the Commission, as applicable, shall be able to create new entries for veterinary medicinal products upon a positive outcome of the procedure for marketing authorisation in accordance with Chapter III of Regulation (EU) 2019/6, registration in accordance with Chapter V of Regulation (EU) 2019/6, permission to use in accordance with Article 5(6) of Regulation (EU) 2019/6 or approval for parallel trade in accordance with Article 102 of Regulation (EU) 2019/6. These entries shall contain the fields laid down in this Regulation. It shall be possible to upload the information from a dataset in the format referred to in Article 10 of this Regulation via the user interface provided for in Article 6 or via the API referred to in Article 9(i) of this Regulation.

1.2 Create provisional veterinary medicinal product entry The reference Member State shall be able to create, for all Member States concerned, provisional entries with version control for veterinary medicinal products in the case of a positive outcome of the procedures for decentralised marketing authorisation, for mutual recognition of national marketing authorisations or for subsequent recognition in the mutual recognition and decentralised marketing authorisation procedures laid down in Sections 3, 4 and 5 of Chapter III of Regulation (EU) 2019/6, respectively, pending the issuing of a marketing authorisation in certain Member States. This shall support variation procedures prior to the issuing of a marketing authorisation in certain Member States and ensure data quality. These entries shall contain the fields laid down in this Regulation. It shall be possible to upload the information from a dataset in the format referred to in Article 10 of this Regulation via the user interface provided for in Article 6 or via the API referred to in Article 9(i) of this Regulation.

1.3 Submit veterinary medicinal product data and documents for the initial input of data The competent authorities or the Commission, as applicable, shall be able to submit, in electronic form, data and documents for the initial input to the Union product database in accordance with the requirements laid down in this Regulation. This shall be possible in the form of a bulk upload through a user interface or file transfer.

1.4 Submit information on parallel-traded veterinary medicinal products In the case of parallel trade as addressed in Article 102 of Regulation (EU) 2019/6, the competent authority of the destination Member State shall be able to submit, in electronic form, information on the parallel-traded veterinary medicinal products in the Union product database in accordance with the requirements laid down in this Regulation.

1.5 Use controlled terms, substance terms and organisation data The Union product database shall use controlled terms, including substance terms and organisation data.

1.6 Use consistent product data in the case of a positive outcome of the procedure for decentralised marketing authorisation, for mutual recognition of national marketing authorisations or for subsequent recognition in the mutual recognition and decentralised marketing authorisation procedures The Union product database shall provide the means to ensure the consistency of data that are common to multiple product entries in the case of a positive outcome in the procedure for decentralised marketing authorisation, for mutual recognition of national marketing authorisations or for subsequent recognition in the mutual recognition and decentralised marketing authorisation procedures laid down in Sections 3, 4 and 5 of Chapter III of Regulation (EU) 2019/6, respectively. This shall support the submission of variations. This shall exclude data and documents provided for the initial input.

1.7 Data validation The Union product database shall validate new veterinary medicinal product data against a set of values and rules agreed upon by the competent authorities, the Commission and the Agency.

1.8 Provide datasets for updates to competent authority databases It shall be possible for competent authorities to obtain the updated datasets from the Union product database in a format that enables them to apply the update to their own databases.

1.9 Assign unique product identifier The Union product database shall assign unique identifiers to veterinary medicinal products to enable automatised data exchange between the Union product database and other Union or competent authorities’ databases.

1.10 Provide data to the Union pharmacovigilance database The Union product database shall allow the Union pharmacovigilance database to obtain the relevant veterinary medicinal product data (including the volumes of sales).

2. Post-Authorisation Changes to Veterinary Medicinal Product Data

2.1 Record variation that does not require assessment Where a variation is included in the list established in accordance with Implementing Regulation (EU) 2021/17 the marketing authorisation holder shall be able to record it in the Union product database.

2.2 Provide product data for creating variation procedures Marketing authorisation holders shall be able to select from their authorised veterinary medicinal products and export the relevant master data that are to be changed, if applicable.

2.3 Approve or reject variations that do not require assessment Approvals or rejections of variations that do not require assessment shall be possible at least via the user interface provided for in Article 6.

2.4 Report on changes to dataset Competent authorities shall be able to obtain a report on the history of changes to the datasets already existing in the Union product database. Marketing authorisation holders shall be able to obtain a report on the history of changes to the datasets already existing in the Union product database for their veterinary medicinal products.

2.5 Update the Union product database following variations requiring assessment or transfers of marketing authorisations The relevant competent authorities shall be able to update the Union product database following variations requiring assessment where this affects the datasets already existing in that database for veterinary medicinal products under their responsibility. This shall include the transfer of marketing authorisations.

2.6 Collect volumes of sales Holders of a marketing authorisation granted in accordance with Chapter III of Regulation (EU) 2019/6, of a registration for homeopathic veterinary medicinal products granted in accordance with Chapter V of Regulation (EU) 2019/6, of veterinary medicinal products referred to in Article 5(6) of Regulation (EU) 2019/6 shall be able to record in the Union product database the annual volume of sales at the appropriate level for each of their veterinary medicinal products.

2.7 Provide volumes of sales for analysis The Union product database shall enable obtaining information on the data on the volume of sales of veterinary medicinal products for analysis.

2.8 Record availability information Marketing authorisation holders shall be able to record and update information on the availability of each of their authorised veterinary medicinal products at the appropriate level in each relevant Member State. Competent authorities shall also be able to record and update this information for veterinary medicinal products under their responsibility in their respective Member States.

2.9 Record marketing authorisation status Competent authorities shall be able to record and update the marketing authorisation status of veterinary medicinal products under their responsibility. Marketing authorisation holders shall be able to update the marketing authorisation status of their veterinary medicinal products in case of suspension or revocation of the marketing authorisations concerned.

2.10 Process post-authorisation changes in parallel The Union product database shall support the processing of post-authorisation changes in parallel.

2.11 Link variations to multiple marketing authorisations The Union product database shall allow for the linking of a single variation to an unlimited number of different marketing authorisations.

2.12 Enter draft data changes Marketing authorisation holders shall be able to enter draft changes to the datasets already existing in the Union product database for their veterinary medicinal products when recording variations that do not require assessment.

3. Access Management

3.1 Public access The general public shall be able to search and view publicly available data.

3.2 Marketing authorisation holder access Marketing authorisation holders shall be able to access (read) all information about their veterinary medicinal products following secure authentication and authorisation. They shall also be able to access (write) selected information about their veterinary medicinal product in order to fulfil any post-marketing obligations provided for in Regulation (EU) 2019/6 following secure authentication and authorisation.

3.3 Competent authorities read access Super users or controlled users from the competent authorities shall be able to access (read) all information contained in the Union product database following secure authentication and authorisation.

3.4 Competent authorities write access Super users or controlled users from the competent authorities shall be able to access (write) the data for the veterinary medicinal products under their responsibility following secure authentication and authorisation.

3.5 Controlled users access right management Super users shall be able to manage the access of controlled users to manage veterinary medicinal product data on their behalf.

4. Provide Data to Super Users and Controlled Users

4.1 Notification of changes to competent authorities Competent authorities shall be automatically notified of: — any changes made by marketing authorisation holders to the datasets existing in the Union product database for veterinary medicinal products under their responsibility; — variations that do not require assessment which have been recorded in the Union product database in respect of veterinary medicinal products under their responsibility; — the outcomes of variations that do not require assessment recorded by reference Member States in respect of veterinary medicinal products under their responsibility; — any updates made by other competent authorities or the Agency as part of the measures to close procedures for variations requiring assessment to the datasets existing in the Union product database for veterinary medicinal products under their responsibility; and — all changes concerning centrally authorised products.

4.2 Notification of changes to marketing authorisation holders Marketing authorisation holders shall be automatically notified of any change made by the relevant competent authorities, the Agency or the Commission, as applicable, to the datasets existing in the Union product database for their veterinary medicinal products. Marketing authorisation holders shall also be automatically notified of the outcomes of variations that do not require assessment recorded by the relevant competent authority or the Commission, as applicable, in respect of their veterinary medicinal products.