Veterinary multicenter/multinational clinical trials applications

According to Article 9 of the Regulation (EU) 2019/6, clinical trials must be approved by the competent authorities of the Member States in which the clinical trial is to take place. However, the Regulation (EU) 2019/6 does not explicitly state how and in which detail an assessment of approval of clinical trials should be performed by the Member States. Therefore, a coordinated approach between Member States may be helpful for the companies as well as for the NCAs with respect to the assessment of clinical trial applications (VET MCMN CT Applications). The CMDv has received a mandate from the HMA Management Group (MG) to work on the collaboration and exchange between Member States involved in the same multi-center clinical trials, without generating additional and disproportionate administrative burden for the Member States.
Consequently, the CMDv has established the Clinical trials Working Group (WG). This WG has developed several documents for veterinary multicentre/multinational clinical trial applications that were proposed for a two-months consultation period from 02 July until 30 August 2024.
CMDv would like to thank all those who provided comments during the consultation phase. These were carefully reviewed and incorporated into the guidance documents wherever possible. An evaluation of the consultation comments can be found below. The updated guidance documents can be found in the new Clinical Trials section of the website.  A pilot phase will now start during the whole year 2025. 
 

Evaluation consultation comments

• Comments AhE
• Comments AVC
• Comments AVM

Guidance on Clinical Trials
 

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 to submit 2024 data is 28 February 2025.

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.