Commission Implementing Regulation (EU) 2021/16 SECTION 4 — DETAILED SPECIFICATIONS OF THE INFORMATION AND DATA TO BE INCLUDED, UPDATED AND SHARED IN THE UNION PRODUCT DATABASE
Article 15–Article 19 · 5 articles
Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Detailed specifications of the information to be included, updated and shared
1. The Union product database shall contain the relevant information based on the data and documents submitted in accordance with Articles 8, 58, 61, 62, 87 and 102 and Annex III of Regulation (EU) 2019/6.
2. The Union product database shall identify each veterinary medicinal product permanently and uniquely. That identification shall be detailed to pack size level.
Marketing authorisation holders shall refer to this unique identification in any subsequent submission relating to that veterinary medicinal product.
3. The Union product database shall identify veterinary medicinal products authorised in several Member States under the same marketing authorisation procedure.
4. Appropriate references shall be maintained to link together related data and documents held in the Union product database.
5. The Agency shall ensure that references to veterinary medicinal products and documents remain stable over the lifetime of products.
Information referred to in Article 55(2) of Regulation (EU) 2019/6
The Agency shall ensure that the Union product database contains the data fields specified in Annex II with their descriptions and the format of data therein to record the information referred to in Article 55(2) of Regulation (EU) 2019/6.
Data to be included in the Union product database in addition to the information referred to in Article 55(2) of Regulation (EU) 2019/6
The Agency shall ensure that, in addition to the information referred to in Article 55(2) of Regulation (EU) 2019/6 recorded by means of the data fields provided for in Article 16, the Union product database also contains at least the data fields specified in Annex III with their descriptions and the format of data therein.
Responsibilities for including, updating and sharing information
1. As of 28 January 2022, competent authorities or the Commission, as applicable, shall, within 30 days of a positive outcome of the procedure for marketing authorisation in accordance with Chapter III of Regulation (EU) 2019/6, registration in accordance with Chapter V of Regulation (EU) 2019/6, permission to use in accordance with Article 5(6) of Regulation (EU) 2019/6 or approval for parallel trade in accordance with Article 102 of Regulation (EU) 2019/6, create new or provisional entries, as relevant, in the Union product database for products under their responsibility by providing to it data and documents submitted in electronic form to them by applicants.
The relevant competent authority or the Commission, as applicable, shall update those entries with the assessment report, after deleting any commercially confidential information contained therein, as soon as it becomes available.
2. The Agency, in collaboration with the Member States and the Commission, shall ensure that business rules are defined and guidance is provided to facilitate data consistency between national systems and the Union product database.
3. Competent authorities, the Commission and the Agency shall ensure that the data entered into the Union product database conform to the format and specifications laid down in this Regulation.
4. The updates to the Union product database referred to in Article 67(4) of Regulation (EU) 2019/6 shall be made within 30 days of the completion of the procedure provided for in Article 67(1) of the same Regulation.
5. Marketing authorisation holders shall record any changes in the availability of each veterinary medicinal product in each relevant Member State as soon as they become aware of them.
6. Marketing authorisation holders shall record the dates of any suspension or revocation of the marketing authorisations concerned as soon as those changes occur.
Where the marketing authorisation holder fails to fulfil this obligation within 30 days, the competent authorities or the Commission, as applicable, shall record and update this information.
In case of disagreement, the competent authorities’ entries in the Union product database shall take precedence.
7. Competent authorities of the destination Member State shall be responsible for recording the necessary information on parallel-traded veterinary medicinal products under their responsibility.
8. Marketing authorisation holders shall be responsible for ensuring that the data and documents they record in datasets existing in the Union product database for their veterinary medicinal products are correct and up to date.
9. Where holders of a marketing authorisation granted in accordance with Chapter III of Regulation (EU) 2019/6, of a registration for homeopathic veterinary medicinal products granted in accordance with Chapter V of Regulation (EU) 2019/6, of veterinary medicinal products referred to in Article 5(6) of Regulation (EU) 2019/6 or of an approval to parallel trade veterinary medicinal products in accordance with Article 102 of Regulation (EU) 2019/6 identify data or document quality issues in the entries created for their veterinary medicinal products in accordance with paragraph (1), or updated in accordance paragraph (4), they shall immediately notify the relevant competent authorities or the Commission, as applicable, which shall correct the data without delay upon verification that the requests are justified.
10. The Agency shall ensure that the responsibilities laid down in this Article may be performed either by super users or controlled users or by systems external to the Union product database. The access of those systems to the Union product database shall be handled as if they were super users or controlled users.
Union Product Database Functionalities Enabling Post-Authorisation Changes to Product Data
1. The Agency shall ensure that the Union product database:
(a)
allows competent authorities, the Commission and marketing authorisation holders to make changes to datasets in at least the following cases, which shall also be possible to be introduced in parallel:
i)
variations that do not require assessment;
ii)
variations requiring assessment;
iii)
all other changes provided for in Regulation (EU) 2019/6, in particular annual volume of sales, information on availability, placing on the market, marketing authorisation status;
(b)
allows competent authorities and the Commission to make any other changes to update or maintain the quality of the datasets contained in the Union product database;
(c)
allows marketing authorisation holders to group changes to veterinary medicinal product datasets, such as to introduce the same change for several veterinary medicinal products or to introduce several changes to one product dataset;
(d)
keeps a log of the recorded variations that do not require assessment and their respective outcomes linked to the relevant veterinary medicinal products, as well as a log of the super users or controlled users who recorded those variations, who approved or rejected them and when those actions were performed;
(e)
allows marketing authorisation holders to record, in the data and document submission component, the necessary procedural information for variations that do not require assessment as described by the relevant fields included in Annex III to this Regulation, as well as to enter draft changes to the data contained in the Union product database or upload updated versions of the documents stored in the Union product database at the time variations are recorded in the Union product database;
(f)
allows draft changes to the data to be confirmed or the most recent document versions to be displayed and the previously approved document versions to be marked and stored as outdated upon the approval of variations that do not require assessment which result in changes to the datasets already existing in the Union product database;
(g)
allows recording rejections for variations that do not require assessment, which otherwise would have resulted in changes to the datasets already existing in the Union product database, by recording the draft data changes or the updated document versions uploaded as rejected;
(h)
allows updating the relevant data or documents stored in the Union product database in the case of approval of variations requiring assessment which result in changes to the datasets already existing in the Union product database and keeps a log of the super users or controlled users who recorded those variations and when those actions were performed;
(i)
sends the necessary automatic notifications in accordance with Functionalities 4.1 and 4.2 provided for in Annex I.
2. The Agency, in collaboration with the competent authorities and the Commission and in consultation with marketing authorisation holders, shall establish the principles and approach for managing the regulatory process in case of parallel variations.
