Report an adverse drug reaction

Veterinarians and animal owners can complete an online form to report adverse reactions to medicines used in animals.

If you encounter any problems, please contact aukaverkun@lyfjastofnun.is

If, for any reason, users are unable to report an adverse reaction by completing the online form, IMA staff may, in exceptional circumstances, assist with completing the form by telephone on 520-2100.

What information is required?

IMA’s forms specify the information requested when reporting an adverse reaction. However, only four items are required for an adverse reaction report to be considered valid. These are:

• Who is reporting (e.g. veterinarian or owner)

• Animal species

• The medicine suspected to be associated with the adverse reaction (full name of the proprietary medicinal product)

• A description of the adverse reaction

Other information that should preferably be included:

• Who administered the medicine

• The reason for treatment, the dose and how it was administered

• The time between the last dose and the onset of the adverse reaction

• How many animals developed symptoms

• How many animals were treated

• How the symptoms were treated

• What the consequences were

• Results of tests/post-mortem examinations

A detailed account may be submitted together with the adverse reaction report, if necessary. Reports received by IMA are assessed by its experts, and further information is requested if necessary.

What happens to the report?

When IMA receives an adverse reaction report, the following process begins:

• The report is assessed and entered into EVVet, the European Medicines Agency’s (EMA) database. Medicines agencies in all EEA Member States have access to this information.

• Adverse reaction reports concerning all veterinary medicinal products are collected and assessed in the above-mentioned databases. Such an assessment may conclude that the information in the Summary of Product Characteristics (SPC)/package leaflet needs to be amended. Medicines agencies in each country may also require the marketing authorisation holder to initiate a detailed investigation into the safety of a medicine. In serious cases, a medicine may need to be withdrawn from the market.