Veterinary Clinical Field Trials
In legislation, a clinical trial is defined as a ‘study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof’
These trials aim to demonstrate or validate the effects of the veterinary medicinal product after administrating the recommended dosage, including:
- Specifying indications and contra-indications based on species, age, breed, and sex.
- Determining directions for use.
- Establishing the product’s safety, tolerance and potential adverse reactions under normal conditions of use.
Trial animals are expected to be under veterinary care and appropriate clinical supervision. For practical purposes, the HPRA considers clinical trials on veterinary medicines as those conducted on the target species using final or near final formulations of the product using the recommended dosage and under field conditions. These trials adhere to Good Clinical Practice guidelines, overseen by an investigator and under the care of a veterinary practitioner.
By contrast, pre-clinical studies on veterinary medicine fall under the scope of the legislation on scientific animal protection (regulated by the HPRA under Directive 2010/63/EU). Regardless of the nature of the trial on a new veterinary medicine, HPRA authorisation is required before conducting any trial on the product in Ireland.
Fees apply to applications for clinical field trials involving veterinary medicines. The fees vary based on whether the trial products are already authorised or not, whether indicated for a major or a minor species, or involve a variation to an existing trial licence.
The HPRA is obliged to consult with the Department of Agriculture, Food and the Marine (DAFM) before determining an application for a veterinary field trial. Special requirements apply to clinical trials involving vaccines, other biological agents, and genetically modified organisms.
Under the legislation, the HPRA licence for a clinical field trial includes both permission for conducting the trial as well as importing the test product(s) involved. A separate import licence from the DAFM is not required.