Veterinary medicines include any medicine that is used for animals, whether it is sold over-the-counter or on prescription.
We authorise veterinary medicines and impose requirements in a number of areas:
- the manufacturing process must meet applicable standards,
- the medicines must be of high quality,
- the medicines must be acceptably safe,
- the effect must be satisfactory,
- the impact on the environment must be as low as possible,
- veterinary medicines may be manufactured only at companies monitored continuously by the drug regulatory authorities.
Rules governing manufacturing, importation, distribution, dispensing and use of veterinary medicines
Veterinary medicines fall under the Danish Medicines Act
In Denmark, veterinary medicines are regulated by the Danish Medicines Act. This also applies to medicines for use in animals such as aquarium fish or other pets.
Products for animals are categorised as medicines if they fall under the definition of section 2 of the Danish Medicines Act, i.e.
- if the products are either to be used to prevent or treat a disease
- and/or of they have a pharmaceutical effect.
Examples are products that contain antibiotic or antiparasitic medications whose purpose is to treat infections in animals.
Contact the Danish Medicines Agency if you are unsure whether a product is a medicine
The Danish Medicines Agency is the responsible authority in regards to the pharmaceutical area in Denmark. We are pleased to offer our assessment of whether a particular product is or is not a medicine. Manufacturers, distributors and consumers alike can ask us for advice: How to distinguish between medicines and other products.
Sale or dispensing of medicine requires a marketing authorisation
Before a medicine can be legally sold or dispensed in Denmark, it must have a marketing authorisation (section 7 of the Danish Medicines Act).
The marketing authorisation provides assurance for animals, the environment and consumers that the product's quality, safety (for patients, users and the environment) and efficacy have been assessed.
The marketing authorisation also provides assurance that there is an acceptable balance between any side effects that the medicine could cause and the effect of the medicine:
Summaries of product characteristics
Summaries of product characteristics for veterinary medicines marketed in Denmark (produktresume.dk,)
Summaries of product characteristics are in Danish only
Summaries of product characteristics for veterinary medicines with a centrally authorised marketing authorisation (EMA's website)
Manufacturing, importation and distribution of medicine require a company authorisation
Before a company is allowed to manufacture, import or distribute a medicine in Denmark, it must hold a section 39 authorisation as provided by section 39 of the Danish Medicines Act:
Notification of activities with handling veterinary medical substances (information in Danish only)
Obligation to treat sick animals/fish
By law, people in Denmark must keep and treat animals with due care. For example, animals must be treated if they are sick (cf. the Danish Animal Welfare Act).
Fish suffering from infectious disease will generally need antibiotics that kill the bacteria causing the infection. Only veterinarians can determine which type of bacteria is causing the disease and can write a prescription for an antibiotic considered to have the best effect.
Special dispensing permit if no authorised medicine is available
In order to avoid that animals suffer unacceptably, veterinarians are in exceptional cases allowed to (subject to direct personal liability) use, dispense or prescribe a medicine that is not marketed. This is possible when there is no other authorised medicine available on the Danish market for treating a particular disease or illness.
Rules governing private individuals' purchases of medicines abroad
Some companies abroad sell veterinary medicines online. However, private individuals are neither allowed to import veterinary medicines into Denmark nor to order it abroad.