Pharmacovigilance

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.

How can you report a pharmacovigilance case?

Most national authorities offer the opportunity to report directly to them, but of course you can also report to the marketing authorisation holder or their representative.

When you want to report a case to us, you can fill in our pharmacovigilance form, or contact us either by phone or email.

Pharmacovigilance form

What falls within the scope of pharmacovigilance?

Pharmacovigilance is not just about adverse events in treated animal(s). The following type of events all fall within the scope of pharmacovigilance:

  • adverse event in animals, including off-label use;
  • adverse events in humans;
  • lack of expected efficacy;
  • validity of the withdrawal period;
  • unexpected effects on the environment;
  • transmission of infectious agents.

What is expected of you?

As mentioned before, pharmacovigilance is supposed to be a joint effort. Without feedback from the field, potential problems will become known at a later stage, or maybe not at all, to government and industry. Therefore, it is expected of you that you report suspected adverse events. The more information and the more details reported, the better the case can be assessed. Based on the available information, every case is assessed on how likely it is that there is a causal connection between the event and the (veterinary) medicinal product(s) involved.  If the available information is incomplete or not specific enough, a case will be assessed as inconclusive. So, if you want to make your case count, please invest the time and effort to submit as much information as possible.

Why is pharmacovigilance important for everyone?

The knowledge obtained through pharmacovigilance is used to maintain a correct and up-to-date picture of the safety and efficacy profile of each authorised product. Without any adverse event reports, the industry and government will assume that the product is safe and effective when used according to the SPC. Without adverse event reports there will be no triggers to investigate or change anything. In order to properly determine if the benefit-risk balance of a product remained unchanged, every bit of knowledge about the active ingredient and about the product is important. Each report contributes to this knowledge. Of course, we always prefer to find out exactly why an adverse event happened, but sometimes this proves to be impossible. However, just studying the case will already increase the level of knowledge of everyone involved. Signal detection is also a very important part of pharmacovigilance. One single report will most likely not trigger a signal, but several reports reporting a similar story most likely will. When looked at it from this angle, again every single case is important.

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