Veterinary medicines

19 June 2019

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.
à Link to 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.
à Link to summaries of product characteristics for products authorised in Denmark (in Danish only)
à Link to 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. à Link to licensing of medicines

  • Veterinary Periodic Safety Update Reports (PSURs). It is compulsory for pharmaceutical companies to prepare PSURs for all veterinary medicines and submit these regularly to the Danish Medicines Agency. A PSUR gives an overview of reported side effects (also called adverse reaction reports), sales data, clinical trials, etc. It is used in practice to update the safety profile of each individual medicinal product. à Link to veterinary PSURs (in Danish only)

  • Reports about side effects (adverse reaction reports): Every medicine can give side effects, and it is important that these are reported to enable an ongoing evaluation of the medicine’s safety and quality. Both the side effects that we know already and those we haven’t seen before are relevant. Veterinarians, healthcare professionals, animal owners and others who are in contact with animals have an obligation to report side effects of veterinary medicines to the Danish Medicines Agency.
    à Link to side effects from veterinary medicines

  • Compassionate use permits: In special circumstances, veterinarians can, at their own responsibility, be authorised to use, dispense or prescribe medicines that are not marketed in Denmark. This is possible in cases where treatment is considered necessary for animal welfare reasons and where no authorised veterinary medicine is available in Denmark.
    à Link to application for compassionate use permits for veterinary use

  • Application for clinical trials in animals: Clinical trials are conducted to investigate the effect and safety of a veterinary medicine. A clinical trial of a veterinary medicine requires an authorisation from the Danish Medicines Agency. à Link to application for clinical trials in animals



 

 

 

 

 

 

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