CLINICAL TRIALS
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 prepared documents that are listed below concerning the collaboration and exchange between Member States involved in the same multi-center clinical trials.
Guidance documents on veterinary multicenter/multinational clinical trials applications
Best practice guide for the clinical trial procedure
Application form for the submission of the clinical trial application