Veterinary Clinical Field Trials
A clinical trial is defined in Regulation 2019/6 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’.
The purpose of such trials is to demonstrate or substantiate the effect of the veterinary medicinal product:
• After administration of the recommended dosage;
• To specify its indications and contra-indications according to species, age, breed and sex, its directions for use, any adverse reactions which it may have and its safety and tolerance under normal conditions of use.
It should be noted that animals used in such trials are expected to be under veterinary care and appropriate clinical care. For practical purposes, the HPRA regards clinical trials on veterinary medicines as those relating to trials carried out on the target species using final or near final formulations of a veterinary medicine at the recommended dosage and under field conditions. Such trials are expected to be conducted under Good Clinical Practice conditions under the responsibility of an investigator and under the care of a veterinary practitioner. By contrast, pre-clinical studies on a veterinary medicine fall under the scope of the legislation on scientific animal protection (i.e. regulated by HPRA under Directive 2010/63/EU).
Thus, whatever the nature of the trial on a new veterinary medicine, HPRA authorisation is required before a trial can be conducted on the product in Ireland.
The following fees apply to applications for clinical field trials involving veterinary medicines:
1. Research trial for an investigational veterinary product unauthorised in the EU for use in a major species: €995
2. Research trial for an investigational veterinary product unauthorised in the EU for use in a minor species: €675
3. Research trial for a veterinary medicine product authorised in the EU for use in a major species: €675
4. Research trial for a veterinary medicine product authorised in the EU for use in a minor species: €375
5. Variations to a current research trial licence: €250
Note that in accordance with the legislation, the HPRA licence for a clinical field trial encompasses both the permission for the conduct of the trial in Ireland as well as the importation of sufficient test product(s) for its proper conduct (a separate import licence from the Department of Agriculture, Food and the Marine (DAFM) is not therefore required). Note also that under the applicable legislation, the HPRA is obliged to consult with the DAFM before reaching a determination of an application submitted for a veterinary field trial. Particular requirements must be followed in relation to clinical trials containing vaccines, other biological agents and genetically modified organisms.
Further information on this topic should be addressed to email@example.com
. Application form for a clinical field trial licence under animal remedies legislation Guide to clinical field trial licence applications under animal remedies legislation Application form for a variation to a veterinary clinical field trial licence