Report side effects of veterinary medicines
Last week, the Medicines Evaluation Board (MEB) called for more attention in reporting possible side effects of medicines. Reporting side effects which may occur when using veterinary medicines is an essential element in improving their safety.
Why is reporting important?
Before a veterinary medicine can be authorised and become available for use in animals, the Veterinary Medicinal Products Unit (VMPU) of the MEB Agency evaluates whether it works effectively and can be used safely.
Possible side effects emerge during studies before the veterinary medicine is authorised. These side effects are listed in the package leaflet of the veterinary medicine. But unknown side effects may still arise after the veterinary medicine has been authorised.
Once the veterinary medicine has been marketed, user experiences of the veterinary medicine are monitored. By collecting these reports, more and more knowledge about the veterinary medicine becomes available. Based on this information, possible actions are laid down to prevent side effects or deal with them better. This is referred to as veterinary drug monitoring or veterinary pharmacovigilance.
Reporting as an animal owner
As an animal owner, you can report side effects if you believe they occurred after administration of a veterinary medicine to your animal(s).
You can report this:
- To a veterinarian
- To the marketing authorisation holder, who is the supplier of the veterinary medicine. Please contact the supplier referred to on the label/package leaflet of the relevant veterinary medicine directly.
- To the Veterinary Medicinal Products Unit of the MEB Agency, via the EU form for reporting a suspected adverse event of a veterinary medicinal product.
Reporting as a veterinarian
As a veterinarian, you fulfil an important gatekeeper's function regarding the use of veterinary medicines. You are obliged to report suspected side effects to the marketing authorisation holder or to the Veterinary Medicinal Products Unit of the MEB Agency.
Reporting can be done via the EU form for reporting a suspected adverse event of a veterinary medicinal product. You can submit this form by e-mail or post.
For more information about side effects, please see the European Medicines Agency (EMA) website.
Reporting as a marketing authorisation holder
As a marketing authorisation holder, you are legally obliged to submit reports of side effects to the medicine authorities. There are detailed instructions on what needs to be reported and how this should be done. More information can be found on the Veterinary pharmacovigilance page.
We would like to bring the following to the attention of marketing authorisation holders:
- Detailed Description of the Pharmacovigilance System (DDPS). When applying for a registration or variation, a detailed description of the pharmacovigilance system (DDPS) must be submitted, as required by Art 12(3) of Directive 2001/82/EC. However, if the latest version of a DDPS has already been approved by a Member State of the EU, you no longer have to send it with an application. In that case, you are kindly requested to attach a DDPS declaration form.
- PSUR Worksharing. When submitting a Periodic Safety Update Report (PSUR) for a worksharing, you are kindly requested to clearly state in the cover letter that it concerns a worksharing to ensure a proper and timely completion of the procedure. See also the information on PSUR worksharing on the MEB website.