A veterinary medicine is a medicine that has been authorised for the treatment of animals. Veterinary medicines are available on prescription from a veterinarian or as over-the-counter products. The tasks we perform related to authorisation, manufacturing, distribution, quality, monitoring of side effects and clinical trials of veterinary medicines are regulated in the Danish Medicines Act.
The Danish medicines act (in Danish only)
Veterinary medicines can be authorised nationally or across the EU through the European Medicines Agency (EMA). Authorised veterinary medicines have a summary of product characteristics, which is a description of the product. Use the following links to search for medicines for animals and read all the relevant information about the medicines.
Summaries of product characteristics for products authorised in Denmark (in Danish only)
Summaries of product characteristics for products authorised in the EU
If a veterinary medicine has been authorised through the European Medicines Agency (EMA), there is additional information available, e.g. about clinical trials. This information is called a European Public Assessment Report (EPAR), and you can find the EPARs here.
How we ensure the quality of medicines for animals
The Danish Medicines Agency performs several tasks related to authorisation, control and monitoring of veterinary medicines with the aim of ensuring that medicines for animals remain safe, available and effective.
The Danish Medicines Agency is responsible for the review of:
- Marketing authorisations: Before a new veterinary medicine can be marketed, it must go through an authorisation procedure, which includes an assessment of quality, safety, efficacy and environmental impact. Licensing of medicines
Marketing Authorisation Holders (MAHs) for veterinary medicinal products are no longer required to submit Periodic Safety Update Reports (PSURs). Instead, this has been replaced by continuous analysis and evaluation of adverse events reported, a process also known as signal management. The MAH is responsible for analyzing all available data regarding potential adverse events in order to identify potential signals. Signal management is a process for active surveillance of reported adverse events of veterinary medicinal products, in order to continuously monitor whether the benefits of a given veterinary medicinal product still outweighs the risk of adverse events – The benefit/risk profile. The aim is to promptly detect any new risk to animals, humans or the environment.
When necessary, and minimum once a year, the MAH should register the result of the signal management process including a conclusion regarding the benefit/risk profile of the Veterinary Medicinal Product in the European Common Adverse Reaction Database (EVD) and IRIS.
The Danish Medicines Agency is part of a collaboration with national competent authorities from other European member states within the European Medicines Agency (EMA) on handling of the signal management process and evaluation of the results registered in EVD from the MAHs.
The European Medicines Agency publish a yearly overview of the suspected adverse events in animals, that have been reported for veterinary medicinal products approved in all EU member states, Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2023