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.
Development, maintaining and upgrading of the Union product database
1. At the latest by 28 January 2022, the Agency shall develop and put into use a database which meets at least the requirements laid down in this Regulation.
2. After 28 January 2022, the Agency shall upgrade existing functionalities of the database and develop whatever other functionalities are considered appropriate and are agreed upon by the competent authorities and the Commission.
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.
3. When establishing the Union product database, the Agency shall, as much as possible, use solutions which already exist, are under development across the regulatory network or are commercially available provided that they meet the objectives of the Union product database.
Submission of information on veterinary medicinal products by the competent authorities for the initial input to the Union product database
1. The competent authorities shall submit, in electronic form, the information required under Article 155 of Regulation (EU) 2019/6 in the format for the initial input to the Union product database prescribed by the Agency.
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.
2. Before submitting their data on veterinary medicinal products to the Agency, the competent authorities shall map them against the detailed specifications laid down in Annexes II and III of this Regulation.
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.
3. Where a dataset for a specific veterinary medicinal product is incomplete for historical reasons (as a result of data or documents not being required from competent authorities or from marketing authorisation holders prior to the application of Regulation (EU) 2019/6), the competent authorities shall clearly indicate in the datasets they provide any fields for which no value is available at time of initial input.
4. The competent authorities shall submit the available documents in an open and, for as many documents as possible, machine-readable format which supports long term archiving.
5. The competent authorities shall submit the information in at least one official language of the Union.
6. Not later than 28 July 2021, the Agency shall make available the necessary environment and IT support to be used by the competent authorities for the testing of the bulk upload of the information for the initial input to the Union product database.
Timelines for the submission for the initial input of data on various types of veterinary medicinal products
1. In addition to the requirement laid down in Article 155 of Regulation (EU) 2019/6:
(a)
at the latest by 28 January 2022, the competent authorities shall submit to the Agency, in electronic form, information on:
(i)
all homeopathic veterinary medicinal products registered in their Member State at that time;
(ii)
all veterinary medicinal products parallel-traded in their Member State at that time;
(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.
2. The competent authorities shall use the format referred to in Article 3(1) and the detailed specifications of the information to be provided laid down in Annexes II and III to this Regulation.
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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
