What is pharmacovigilance?

The main goal of pharmacovigilance is to monitor and guard the safety and efficacy of (veterinary) medicinal products post registration. Pharmacovigilance is assumed to be a joint effort of government, industry, veterinarians and consumers. After all, a safe and effective product is to everyone’s advantage.

It is generally accepted that the use of any (veterinary) medicinal product brings certain risks with it. These risks, however, should be in balance with the benefits to be gained from the use of the product. This is the so-called benefit-risk balance. During the process of registration this balance will be made up for the first time. The safety and efficacy of a product is intensively studied during this process.

Post-registration this balance is supposed to remain unchanged. However, despite comprehensive pre-registration studies, unexpected adverse events can still happen once the veterinary medicinal product is released onto the market. After all, this will be the first time that the product is going to be used extensively and under a wide variety of circumstances. But even when a veterinary medicinal product has already been marketed for a long time, unexpected events can still occur when, for example, circumstances change or there is some sort of interaction with a newly marketed product.