User interface
1. The Union product database shall include graphical user interfaces providing access to users in accordance with their access rights established in Articles 12 and 13.
2. The Agency shall ensure that the development, operation and maintenance of the Union product database is done in a manner that conforms to Directive (EU) 2016/2102 of the European Parliament and of the Council ( 4 ) .
3. The graphical user interface of the Union product database shall support responsive web design.
4. The graphical user interface of the Union product database for the general public shall be available in all official languages of the Union.
5. The graphical user interface of the Union product database for super users and controlled users shall be available at least in the English language.
Components
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.
Functionalities of the Union product database
The Union product database shall have at least the functionalities listed in Annex I.
Electronic data and document exchange mechanism for exchanging with other systems
The Agency shall ensure that:
(a)
the electronic data and document exchange mechanism follows, to the extent that optimal operability of the Union product database does not adversely impact other Union systems, current recognised international standards for the identification of medicinal products and exchange of medicinal product information or relevant subsets thereof;
(b)
the structure of data is consistent between the Union product database and other Union systems using the same reference data;
(c)
the Union product database functions as the Union master data repository where information about veterinary medicinal products is registered;
(d)
the Union product database provides a functionality to enable other systems to interoperate with it;
(e)
the Union product database consumes reference data from other existing databases or IT tools to avoid duplication of data input at Union level and ensure data quality;
(f)
the Union product database is able to consume structured data provided in the course of the regulatory process, as relevant;
(g)
the Union product database provides the necessary data to the Union pharmacovigilance database;
(h)
the Union product database is linked to the Union database of manufacturing, import and wholesale distribution;
(i)
the Union product database has a service-oriented Application Programming Interface (‘API’) for the exchange of data and documents with the systems used by marketing authorisation holders, competent authorities, the Agency and the Commission.
Format for electronic submission to the Union product database
The Agency shall ensure that:
(a)
the format for electronic submission consists of documents and structured data on veterinary medicinal products, as applicable;
(b)
the data format:
(i)
follows, to the extent that optimal operability of the Union product database does not adversely impact other Union systems, current recognised international standards for the identification of medicinal products and exchange of medicinal product information or relevant subsets thereof;
(ii)
uses, as much as possible, structured data and controlled terms, including substance terms and organisation data, to ensure data quality;
(c)
documents are provided in an open and machine-readable document format which supports long term archiving.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
