The veterinary medicinal products for clinical trials are active substances or placebos presented in a developed pharmaceutical form whose formula is established, the characteristics and specifications defined. Their preparation is mass-produced, in significant quantities in a pilot or industrial production unit.
These may be medicinal products which already benefit from a marketing authorisation, but used, presented or packaged differently from the authorised speciality, or used for a different indication of the authorised speciality.
The following are therefore excluded from this definition and from the scope of the abovementioned laws and regulations:
- active substances, in a form or formulation under development, whose formula, characteristics and specifications are being defined and may be subject to change as studies progress;
- preparations which are not serially manufactured, but usually formulated in small quantities and in a formulation laboratory.
- products used in non-clinical and preclinical laboratory studies to study their physico-chemical characteristics, preliminary stability, animal behaviour;
- products used in laboratory studies to determine their properties and to improve and optimise the formula to define the composition of a final formulation.
Within two months prior to the clinical trial of a veterinary medicinal product, the sponsor shall notify the Director General of the National Agency for Food, Environmental and Labour Health Safety by submitting a dossier.
To apply for a clinical trial authorisation for veterinary medicinal products
If the clinical trial concerns a veterinary medicinal product containing genetically modified organisms, specific provisions exist for the examination of that application.