As a veterinary pharmaceutical company, Virbac is subject to the regulatory constraints which apply to the whole pharmaceutical industry. They are just as important, or even more important in some technical respects, than those applying to human pharmacy (eco-toxicity, residues of tissue).
The following content has been taken from the Virbac Corporate Website for further information visit www.virbac.com.
In Europe, the United States and Japan, but also in most industrialised countries, the various regulations require veterinary medicines to be registered with national or community authorities to ensure the quality, harmlessness and effectiveness of the products put on the market. This procedure necessitates complete technical control of the development of each speciality and a thorough knowledge of the terms and conditions of registration that are more or less specific to each country or group of countries.
Throughout the economic life of a veterinary speciality, any modification, even if only minor (manufacturing site and procedure, improvement in the quality of the ingredients, side-effects observed, etc.), must be declared to the competent authorities. The technical monitoring of a veterinary medicine is constant, so as to ensure compliance with the regulations which themselves develop according to the new techniques introduced but also according to changes in behaviour in civil society (for example, taking eco-toxicity into account in the use of a speciality). The regulatory status of a medicine is therefore not fixed.
Those constraints, decreed by Europe, the United States, Japan and some other industrialised countries, are progressively transcribed into the legislation of most of the countries which regulate the sphere of veterinary medicine (Brazil, China, India, etc.).
For Virbac, this means about 4,500 registrations obtained in more than 100 countries, managed by the Regulatory Matters department and its regional correspondents. Every year, about 3,000 regulatory procedures are undertaken by Virbac's registered office to obtain and maintain the company's authorisations.