Components
Article 7
The Union product database shall consist of at least the following components: (a) an access management component which, with the use of authentication and authorisation processes, manages the control of access to data or functionalities and ensures that super users and controlled users have the appropriate access to the resources provided by the Union product database and the proper permissions to perform actions in the Union product database; (b) a data and document submission component which allows submission to the Union product database of data and documents relating to new veterinary medicinal products, variations and other post-authorisation changes to the datasets already existing in the Union product database for veterinary medicinal products; (c) a data and document repository component which manages all data and documents that enter into the Union product database and uses at least the following functionalities: (i) a data recording functionality which manages the capability of recording data, including versioning; (ii) a data quality validation functionality which automatically manages the technical validation and quality check on data prior to their recording in the Union product database; (iii) a data history functionality which manages the audit trail and traceability of data changes; (iv) a document management functionality which manages the storage, versioning of the stored documents to distinguish between the latest approved versions, versions which have been approved previously but replaced by newer versions, as well as any versions rejected as a result of rejections of variations that do not require assessment, and access to documents. (d) a Union product database portal which, with the use of data publishing, data searching, viewing and exporting, as well as data analytics, presents information to users and makes certain features available to them in accordance with their access rights; (e) a component for managing variations that do not require assessment which allows the relevant competent authority or the Commission, as applicable, to be notified and to approve or reject variations that do not require assessment prior to the update in the Union product database, to update the datasets accordingly and to store and update related documentation; (f) a general public module which is accessed via the Union product database portal and allows the general public to view and perform searches on all publicly available data and documents on veterinary medicinal products referred to in Article 56 of Regulation (EU) 2019/6.