Commission Implementing Regulation (EU) 2021/16 of 8 January 2021 laying down the necessary measures and practical arrangements for the Union database on veterinary medicinal products (Union product database)
Commission Implementing Regulation (EU) 2021/16of 8 January 2021laying down the necessary measures and practical arrangements for the Union database on veterinary medicinal products (Union product database)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/ECOJ L 4, 7.1.2019, p. 43., and in particular Article 55(3) thereof,Whereas:(1)Article 55(1) of Regulation (EU) 2019/6 requires the European Medicines Agency ("the Agency") to establish and, in cooperation with the Member States, maintain a Union database on veterinary medicinal products ("Union product database").(2)The Commission is required under Article 55(3) of Regulation (EU) 2019/6 to adopt, by means of implementing acts, necessary measures and practical arrangements for the establishment and maintenance of the Union product database.(3)The Union product database is aimed at enhancing the single market by providing information on veterinary medicinal products available in Member States and allowing health professionals to obtain information on veterinary medicinal products which might be considered for elaboration of potential treatment alternatives where no suitable veterinary medicinal product is authorised in their Member State.(4)The Union product database should increase overall transparency by providing the general public with the widest possible access to the information it contains after the deletion of commercially confidential information and personal data by the competent authorities.(5)The Union product database should contain harmonised and consistent data of quality, provide capabilities that offer interoperability with other national and Union IT systems which utilise veterinary medicinal product data and allow integration in the activities of the regulatory network.(6)Regulation (EU) 2019/6 provides also for the establishment of other databases. To ensure interoperability and to enable the Union product database to interface with those databases, the structure of data should be harmonised between the different systems using the same reference data.(7)The Union product database should be functional and operational from the date of application of Regulation (EU) 2019/6 (28 January 2022) to enable the regulatory processes provided for therein. It should also be able to adapt to any changes which occur within the regulatory network, to meet the needs of the regulatory operating models as they develop and to keep up to speed with technical and scientific progress. This necessitates an incremental approach to its establishment and maintenance. By the date of application of Regulation (EU) 2019/6, the Agency should ensure that the Union product database meets at least all functional requirements stemming from that Regulation. Thereafter, the Agency should continue developing additional functionalities, including such that could further reduce administrative burden and contribute to the harmonisation of processes across the regulatory network.(8)In order to alleviate the administrative burden of the competent authorities, the initial input of information by the competent authorities to the Agency on all veterinary medicinal products should be permitted on a phased basis.(9)The Union product database should be composed of interrelated components which will allow a comprehensive and uniform management of the information which will be stored. It should also be able to receive up-to-date information from existing catalogues of terms maintained by the Agency. Therefore, it is to be understood as a database system, rather than a standalone IT solution.(10)The Union product database should be developed with the aim of avoiding the duplicate input of data in different Union systems. This should ensure that there is a single source for each type of information provided and that data is entered only once to reduce excessive administrative burden and to mitigate the risk of inconsistency. The datasets contained in the Union product database should be the most recent and correct ones. To this end, the Union product database should make available the latest datasets to enable the competent authorities to keep their respective national systems aligned and synchronised with the Union product database. It should also be possible for the competent authorities, the Commission and marketing authorisation holders to use their own systems to update the Union product database as needed.(11)To the highest extent possible, the data and documents contained in the Union product database should be in a format which allows machine readability. However, not all documents required under Regulation (EU) 2019/6, especially those to be submitted by the competent authorities for initial input into the Union product database, may be available in such a format. Therefore, specific arrangements should be in place as regards documents to be provided by the competent authorities at the time of initial input of data from the Member States on veterinary medicinal products.(12)In accordance with Commission Implementing Regulation (EU) 2021/17Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (see page 22 of this Official Journal)., certain variations that do not require assessment would result in changes to the datasets in the Union product database while others would not. Both types could also necessitate supporting documentation. All such variations should be recorded by marketing authorisation holders and logged by the Union product database for approval or rejection by the competent authorities as provided for in Article 61 of Regulation (EU) 2019/6. The Union product database should also allow marketing authorisation holders to record subsequent changes before the ones recorded previously have been processed by the competent authorities. Furthermore, the regulatory process allows for concurrent applications for and processing of variations requiring assessment, as well as their grouping and work-sharing. Therefore, the Union product database should support the competent authorities in receiving variations in parallel.(13)Different actors should have different access levels to the Union product database as provided for in Article 56 of Regulation (EU) 2019/6. A detailed access policy should therefore be drawn up and applied by the Agency, in collaboration with the competent authorities and the Commission and in consultation with marketing authorisation holders, before the Union product database becomes operational. It should enable actors to perform their obligations as set down in Regulation (EU) 2019/6, while protecting commercially confidential information and personal data, and should therefore provide different levels of access to the Union product database processes.(14)Continuity must be safeguarded should the Union product database, or any of its components, become unavailable. Adequate contingency arrangements should therefore be drawn up and applied by the Agency before the Union product database becomes operational.(15)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products referred to in Article 145 of Regulation (EU) 2019/6,HAS ADOPTED THIS REGULATION: