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Side effects

Why side effects?

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.

What is pharmacovigilance?

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:

  • the (national and European) authorities;
  • the marketing authorisation holder, Alfasan, and
  • the distributors, veterinarians and animal owners, therefore you.

Below is a brief description of the roles of these different parties.

What is the role of the authorities?

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.

What is the role of the marketing authorisation holder/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.

What is the role of the distributors, veterinarians and animal owners?

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.

What can be reported?

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:

  • Side effects in animals (including side effects following off-label use);
  • Side effects in people;
  • Reduced efficacy;
  • Waiting period problems (in farm animals);
  • Environmental issues.

Why report all these issues?

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.

How can a report be submitted?

  • By reporting directly to the competent authority in your country. The national authority will forward the report to the marketing authorisation holder.
  • You can also submit the report directly to the marketing authorisation holder who will then forward this report to the relevant authorities. If it concerns a product of Alfasan, you can contact our veterinarian via the reporting form. If you need to report a serious side effect and it cannot wait until the next business day, then you can use of the 24-hour QPPV number (0348-453757).

DOWNLOAD the notification form´╗┐´╗┐

Questions or comments?

Please do not hesitate to contact Alfasan if you have any questions or comments regarding the above mentioned information.