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) in future. The CMDv has received a mandate from the HMA Management Group (MG) to work on the collaboration and/or 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 are now proposed for a two-months consultation period:

• application form for the submission of the clinical trial application,
• best practice guide for the clinical trial procedure,
• template for the compilation of the list of questions.

The consultation period is organised from 02 July until 30 August 2024.

All comments must be sent to the CMDv secretariat at cmdvnoSpam@noSpamema.europanoSpam.eu including “VET MCMN CTAs comments” in the e-mail subject. 

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 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)

As per Article 58(12) of Regulation (EU) 2019/6, Marketing Authorisation Holders (MAHs) are required to submit in the Union Product Database (UPD) the annual volume of sales for each of their veterinary medicinal products.

As announced previously by the European Medicines Agency (EMA), the submission deadline for the MAHs to provide annual Volume of Sales for the 2022 calendar year has been set to 30 June 2023.

As of 1 August 2023, the submission of Volume of Sales data is still incomplete and its rate lower than expected. Sales data are missing for ¾ of the products registered in UPD i.e. data have not been provided for 31,000+ medicinal products.

All MAHs must submit 2022 sales data without further delay! We advise users to focus on and undertake any necessary testing related to the submission of EU/EEA sales.

The deadline for submitting the data for the 2023 calendar year has now been set for end of February 2024. Thereafter the deadline to provide annual volume of sales will be set as the end of February the following year. For example, the deadline for submitting the data for the 2024 calendar year will be February 2025; for the 2025 calendar year will be February 2026, and so on.

CMDv letter to MAH – Submission of Volume of Sales data