Distribution and use of veterinary medicinal products

Distribution of VMPs must take place through authorised pharmacies.

Apart from vitamins, some ectoparasitics and some mineral complexes most VMP's for veterinary use are prescription only medicine (POM).

POMs may be obtained only from a pharmacy or from a veterinarian. All VMPs must be distributed to the veterinarian by a pharmacy. The veterinarian may hold a stock of products obtained from a pharmacy, and may on certain conditions supply products directly to the farmer for the treatment of animals under his/her care.

Veterinary vaccines can be distributed either by pharmacies or by the National Veterinary Institute.

Veterinarians must use authorised VMPs for the treatment of animals, and the VMPs shall be used in accordance with the terms of the marketing authorisation. If an authorised product does not exist for an indication for an animal species, a veterinarian may exceptionally use, dispense or prescribe according to Article 112 (in non-food-producing animal species), Article 113 (in food-producing terrestrial animal species) or Article 114 (food-producing aquatic species) in Regulation on veterinary medicinal products.

In accordance with EU Regulations, only pharmacologically active substances, for which an MRL (Maximum Residue Level) has been established, may be used for food producing animals.

Some substances cannot be used. Certain antimicrobials or groups of antimicrobials are reserved for treatment of certain infections in humans, and the use of stilbenes and thyreostatics are prohibited. However, thyreostatics may be used for cats or dogs with hyperthyroidism. You can read more about the antimicrobials reserved for human use in Regulation 2022/1255.

Antimicrobial medicinal products

• shall not be applied routinely nor used to compensate for poor hygiene, inadequate animal husbandry or lack of care or to compensate for poor farm management.
• shall not be used in animals for the purpose of promoting growth nor to increase yield.

Hormones and substances with hormone-like effect, including somatotropins, are not allowed for food producing or fur animals for growth and yield promoting purposes.

Beta-agonists and substances with estrogenic, androgenic, and gestagenic effect are prohibited for use in production animals. However, in accordance with EU Directive 96/22, authorised VMP's with estrogenic, androgenic and gestagenic effect may be used in production animals for zootechnical or therapeutic purposes provided that a number of conditions are met. Likewise, beta-agonists and allyltrenbolone may be used in horses for specified therapeutic purposes.  

Certain groups of VMPs may only be used by the veterinarian in person:

• Analgesics for injection excluding non-steroid anti-inflammatory drugs (NSAID) for injection
• Anaesthetics for inhalation and injection
• Opioids, opiates, barbiturates, benzodiazepines and tranquilizers 
• Selenium-containing VMP's for injection
• Parasympathomimetics for injection and parasympatholytics for injection
• Sympathomimetics for injection and sympatholytics for injection
• The following hormones and compounds with hormone-like effect for injection:
• Adrenocorticotropic hormones
• Natural and synthetic adrenal cortex steroids
• Natural and synthetic sex hormones, including anabolic steroids
• Oxytocin and oxytocin analogues to enhance labour
• Prostaglandins and prostaglandin analogues
• VMPs authorised for intravenous injection only (IV).​

Antibiotics may only be used for production animals, if the veterinarian has diagnosed an infection which justifies its use.  Veterinarians may only on certain conditions dispense or prescribe antibiotics for use by the farmer, and the farmer must follow the advice and instructions given by the veterinarian. Instructions must be given in writing and must include identification of target animals, diagnosis, VMP and dosage, clinical symptoms that must be observed before treatment, withdrawal period, and administration route.

Fluoroquinolones, 3. and 4, generation cephalosporines and colistin may only be used, dispensed or prescribed for production animals, if it has been verified by a laboratory examination that the agent causing disease is not sensitive to any other authorised antibiotic. In case of an acute disease, treatment may be initiated before the result of the laboratory examination is known. A different antibiotic must be used, if the causative agent shows sensitivity to other kinds of antibiotics than fluoroquinolones, 3. and 4. generation cephalosporines or colistin. In case of use of fluoroquinolones, 3. and 4. generation cephalosporines or colistin for production animals, the Regional Veterinary Officer must be informed within two weeks after termination of the treatment.

A Veterinary Advisory Service Contract (VASC) is a one-to-one agreement between a farmer and a veterinarian.

Farmers with a VASC have frequent visits from their veterinarian and are allowed to stock medicines and give antimicrobial treatments between the visits from the veterinarian.

Farmers can treat new disease cases follow the veterinarian’s written instructions laid down in the herd health plan.

The most important aims of the VASC are to focus on advice and prevention of illness rather than treatment, to optimize the use of antimicrobials in order to minimize antimicrobial resistance and to improve animal welfare. 

Between 1995 and 2010, VASCs were voluntary.  In 2010, it became mandatory for owners of large herds of cattle and pigs and for mink farm owners to sign a VASC.

Small cattle and pig holdings as well as sheep and goat holdings and fish farms may be registered for advisory services on a voluntary basis.

Whenever antibiotics or other VMPs, for which withdrawal periods have been set, are administered to food producing animals – either by the veterinarian in person or by the farmer – the veterinarian must inform the farmer about the withdrawal periods for the VMPs used.

Withdrawal periods are set in order to avoid residues in meat from slaughtered animals and in products (milk, eggs and honey) to be delivered for human consumption. Such information must be given verbally and in writing, and both the farmer and the veterinarian must keep a copy for at least 5 years.

Meat, milk and eggs from treated animals are not allowed for human consumption during the withdrawal period.

Danish provisions specify, that it is prohibited to deliver animals for slaughter, or to deliver meat, milk, eggs, fish, honey or other animal products for consumption if they contain residues of VMPs in an amount that exceeds the MRL established in the valid EU-provisions, or if they contain residues from illegal treatment. Likewise, it is prohibited to manufacture or sell meat or products for human consumption if they contain residues exceeding the MRLs.

Suspected violations of the provisions described will be punished with an administrative fine or reported to the police.

As required ​in EU-provisions, control for residues is performed in accordance with an annual residue plan. Furthermore, veterinarians and farmers are subject to control by the Regional Veterinary Officer.

All prescription only medicine (POM) is recorded in the official database, VetStat.

When POM is sold from either a pharmacy or a feed-mill it is recorded in VetStat.

For animal species used for agricultural production (except horses), the veterinarian must include additional information regarding the use of the medicine.

Reporting from the veterinarian includes information on

• the veterinarian responsible for the treatment,
• the VMP prescribed,
• identification of the target herd and the species (including age-group and disease-group) to be treated.

For horses and pet animals, reports are made only by the pharmacy.

More information on VetStat and how to access the database can be found on the webpage VetStat.

Owners or, if the animals are not kept by the owners, keepers of food-producing animals shall keep records of the VMPs used according to Article 108 of Regulation on veterinary medicinal products.

Owners or keepers of fur-animals shall keep records of the POMs used cf. § 14 of bekendtgørelse om dyreejeres anvendelse af lægemidler til dyr mv.

Registrations must be kept for 5 years.

Animal holders and their employees who need to administer POMs to production animals must have completed an approved course on the use of VMPs.

Production animals means animals intended for food production and fur animals.

Doctors, nurses, veterinary nurses or animal keepers (e.g. at zoos) too must complete a course on the use of VMPs.​

Special courses are required before treating cows for hypocalcemia and/or retained placenta with infection (only allowed in herds with a VASC) and the use of local anaesthetics for piglets prior to castration. ​

The Danish Veterinary and Food Administration does not offer courses. Courses can be offered by veterinarians, agricultural schools or others, but the lecturer must be a veterinarian.

You can read more on the DVFA webpage "medicinhåndtering"

The Danish legislation and EU Directives on medical devices only include medical devices for human use. Medical devices exclusively for veterinary use are not covered by the legislation. If medical devices intended for human use are used  for veterinary purposes, they will be subject to the legislation on medical devices. You can find more information on the Danish Medicines Agency's website.

Medical devices containing products of animal origin

If the medical devices are not covered by the legislation on medical devices and contain products of animal origin, the medical devices are covered by the animal by-products Regulation (EC) 1069/2009 and Regulation (EC) 142/2011.

In this case, a registration is needed according to the animal by-products Regulation, and the requirements for trading animal by-products should be fulfilled. Registration should be done at the local veterinary inspection unit.

Read more on the Danish Veterinary and Food Administration's website on animal by-products

Laboratory reagents and test kits are, as long as they are prepackaged, exempt from the requirements of the animal by-products Regulation (EC) no. 1069/2009.