Before a veterinary medicine can be authorised, extensive research has been done into the efficacy and safety of the product concerned. Once a veterinary medicine is on the market and used on a large scale, new – and already known – side effects may occur.
In simple terms, pharmacovigilance is about identifying risks. In addition, it is about monitoring and improving the efficacy and safety of a veterinary medicine. There are various parties involved in this:
Below is a brief description of the roles of these different parties.
The (national and European) authorities are concerned with the legislation relating to pharmacovigilance. Furthermore, they keep a digital database of all reports and conducts regular inspections of the various marketing authorisation holders. Also of Alfasan.
The marketing authorisation holder is obliged to maintain a pharmacovigilance system where, among other things, all side effects are recorded. Safety reports must furthermore be submitted to the competent authorities on a regular basis.
It is important that all procedures concerning pharmacovigilance are properly recorded in documents. In addition, certain agreements with distributors are laid down in contracts. Finally, every marketing authorisation holder has to employ a QPPV. QPPV is short for “Qualified Person for PharmacoVigilance”. This person is preferably a veterinarian and he or she is responsible for all issues concerning pharmacovigilance. The QPPV of Alfasan is a veterinarian who is available 24 hours per day.
Without feedback from the customer, the marketing authorisation holder and the national authorities are not informed quickly enough, or not at all, about side effects or other matters. It is therefore important that distributors, veterinarians and animal owners like yourself report issues relating to pharmacovigilance, including side effects, to the marketing authorisation holder or the national authorities.
Pharmacovigilance is broader than just reporting (known or unknown) side effects. The following matters can be reported to the national authorities or the marketing authorisation holder:
Alfasan appreciates receiving information concerning side effects and other issues relating to pharmacovigilance from you! In this way these issues can be examined further. Your reports will increase knowledge on the efficacy and safety of our products. And product information, such as package inserts and labels, can also be optimised.
Without reports, the competent authorities and the marketing authorisation holder assume that the efficacy and safety of a veterinary medicinal product matches the product information. Through reports these issues can be investigated – and changed where necessary – so the efficacy and safety of our veterinary medicines can remain optimal.
Questions or comments?
Please do not hesitate to contact Alfasan if you have any questions or comments regarding the above mentioned information.