What happens to your report?

Your report is an important part of a larger picture

When you have filled out the form, it is sent to us at the Danish Medicines Agency. We use the information from the form to create a so-called ’narrative’ in English. The narrative describes what happened, and in which order. We also code the report with standardised medical words from ’Veterinary Dictionary for Drug Regulatory Activities’ (VeDDRA), describing the side effects as accurately as possible. The coding with VeDDRA makes it possible to search for similar reports in the future.

Then the narrative is entered into the European adverse event database ’EudraVigilance Veterinary’ together with all the factual information from the form.

The report is anonymised to hinder identification of persons or animals, and access to the database is also limited to different extents depending on whether it is a national authority, a medical company or a civilian looking.

The report is then included in the total dataset available in the European database. This database is monitored by both medical companies (marketing authorisation holders) and national authorities all over the EU. The collected data from reports is monitored and when a suspicion of a potential association between a medicine and a new or changed side effect arise, it is further investigated as a so-called ‘signal’.

The investigation of signals from the European database includes a thorough analysis of the reports and any other available data relevant to the topic. At this point, the likelihood of a causal association between the potential side effect and the medicine is also assessed. It is furthermore considered whether there is a need for additional measures to minimise the risks of using the medicine.

The most commonly implemented risk minimisation measure is an update of the product information to include information and/or guidance regarding a side effect, but other examples include sending out direct communication to animal health care professionals, temporary suspension and/or recall of a veterinary medicinal product, and in very serious and rare cases a product may be permanently removed from the market. Luckily, such interventions are very rare, and there is no need to fear that reporting of side effects or lack or efficacy will lead to medicines disappearing from the market.