Q&A on transitional arrangements

CMDv has prepared a Q&A document in order to assist both MAHs and NCAs in the management of the transition between the requirements of Directive 2001/82/EC and Regulation (EU) 2019/6.
Several items are developed in this document as renewals, update of QRD templates and transition from PSUR to signal management.
This document has also been updated with new developments, for instance the transition from the DDPS to the PSMF.

Additional information:
EMA: Q&A on renewals (link)
EMA: publication of version 9.1 of the QRD templates (link)
EC: Commission Notice on marketing authorisations for veterinary medicinal products for which the expiry of the 5-year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6 2021/C 274/02 (link)

Marketing authorisation holders must submit the annual volume of sales data for each veterinary medicinal product in the Union Product Database (UPD), as required by Article 58(12) of Regulation (EU) 2019/6.

The deadline recurs annually, i.e. 2025 calendar year data must be submitted by the last day of February 2026 and 2026 calendar year data must be submitted by February 2027.

More information regarding the requirements, process and frequently asked questions are available on the European Medicines Agency website. 

Specificities for Homeopathic VMP registered according to article 86 and for VMP registered according to article 5(6): 

Under the Regulation, Article 55 also applies to these products. This means that Volume of Sales (VoS) data for these products must be submitted (at least) annually to the Union Product Database (UPD). Furthermore, Pharmacovigilance obligations (Chapter IV, Section 5) apply to these products as well, which also implies the need to submit VoS data for the related adverse event incidence calculation and publication.

Consequently, the company responsible for placing these products on the market are required to submit VoS data and updates to the availability status in the UPD.

As owner of those products, what you need to do

1. Register in the UPD if you haven’t already.
2. Ensure that your products are listed in the Union Product Database (https://medicines.health.europa.eu/veterinary/en) and that your company is listed as the “product owner” for the relevant products. If you believe any products are missing, please contact [the national competent authority in the authorisation country].
3. Prepare to submit 2025 sales data during the 2026 submission cycle. The deadline for submission is the end of February 2026. 

Information on the UPD and a registration guide can be found on the European Medicines Agency (EMA) website, here: https://www.ema.europa.eu/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation/union-product-database#registration-and-access-to-upd-restricted-area-70929

A video tutorial how to submit the data is available on the EMA website, here: https://www.ema.europa.eu/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation/union-product-database#video-tutorials-7266

The national competent authorities where the VMP are authorised can be contacted in case of questions (see contact points in the CMDv website: Heads of Medicines Agencies: Procedural Contact Points).