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)

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/EC (1), 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) 2021/17 (2), 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:

SECTION 1

GENERAL PROVISIONS

Article 1

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a) ‘user’ means any person which interacts with the Union product database via its functions;

(b) ‘super user’ means one user who is designated by each marketing authorisation holder, competent authority, the Agency or the Commission and is authorised by the Agency to perform actions in the Union product database in accordance with the access rights assigned to their user profiles;

(c) ‘controlled user’ means any user authorised by a super user to perform actions in the Union product database on that super user’s behalf in accordance with the access rights assigned to that super user’s profile;

(d) ‘open format’ means open format as defined in Article 2(14) of Directive (EU) 2019/1024 of the European Parliament and of the Council (3);

(e) ‘machine-readable format’ means machine-readable format as defined in Article 2(13) of Directive (EU) 2019/1024;

(f) ‘structured data’ means data in predefined and standardised format which can be parsed, organised and processed by computers;

(g) ‘Union systems’ means European Union IT systems under the control of the Agency, the Commission or the Member States;

(h) ‘restricted data’ means any data not classified as public, as set out in the access policy referred to in Article 13 of this Regulation.

Article 2

Development, maintaining and upgrading of the Union product database

At the latest, by 28 January 2022, the Agency shall, in consultation with the Member States, the Commission and marketing authorisation holders, develop a plan for the further development and upgrading of the Union product database. The Agency shall update this plan every two years in light of the progress made and the needs identified by the regulatory network referred to in Chapter X of Regulation (EU) 2019/6 and the feedback provided by the users of the Union product database.

Article 3

Submission of information on veterinary medicinal products by the competent authorities for the initial input to the Union product database

Not later than 21 January 2021, the Agency shall prescribe the format of the data and documents (‘dataset’) which together form the information to be provided.

The Agency shall ensure that the required controlled terms, including substance terms and organisation data, with unique term and data identifiers and whose values can only be selected from a predefined set of values specified or maintained by the Agency are available for the mapping of the data.

Article 4

Timelines for the submission for the initial input of data on various types of veterinary medicinal products

(b) at the latest by 28 January 2024, the competent authorities shall submit to the Agency, in electronic form, information on all veterinary medicinal products that had been exempted in their Member State from the provisions for marketing authorisation at that time.

Article 5

Order of precedence

In case of discrepancies between the datasets already existing in the Member States’ systems and the Union product database, the latter shall prevail in respect of the information contained therein.

This shall not preclude the Member States from synchronising the Union product database with the most up-to-date information on veterinary medicinal products which results from the ongoing regulatory process and is contained in their national systems.

SECTION 2

TECHNICAL SPECIFICATIONS OF THE UNION PRODUCT DATABASE

Article 6

User interface

Article 7

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;

(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.

Article 8

Functionalities of the Union product database

The Union product database shall have at least the functionalities listed in Annex I.

Article 9

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.

Article 10

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;

(c) documents are provided in an open and machine-readable document format which supports long term archiving.

SECTION 3

PRACTICAL ARRANGEMENTS FOR THE FUNCTIONING OF THE UNION PRODUCT DATABASE

Article 11

Protection of commercially confidential information