Veterinary drugs

from Wikipedia, the free encyclopedia

Veterinary medicinal products are substances or compositions of substances which are intended to cure or prevent animal diseases, or which can be administered to an animal or applied to an animal in order to either restore or influence animal body functions or to make a medical diagnosis .

The law on veterinary medicinal products is harmonized across the EU by Directive 2001/82 / EC (Community code for veterinary medicinal products). In many areas it is similar to the law for human medicinal products, but has some specific features.

Economical meaning

In 2014, sales of veterinary medicinal products amounted to 771 million euros in Germany and 23.9 billion US dollars worldwide. In 2008, around 59% of global sales were accounted for by the treatment of livestock cattle (27%), pigs (16%), poultry (11%) and sheep (5%).

Typical veterinary drugs

Typical veterinary drugs, which also make up a large part of the total sales of veterinary drugs, are:

The veterinary medicinal products also include euthanasia .

Legal Regulations

The legal regulations for veterinary medicinal products are largely similar to those for human medicinal products, which are also used at European level in terms of their differentiation from other products (nutritional products ( food / feed ), medical products , personal care products ), in particular with regard to the production of medicinal products and drug approval Community codes are harmonized.

In Germany, the manufacture and sale of veterinary medicinal products and those of human medicinal products are regulated in the national pharmaceutical law; In addition, in Section 9 it contains special provisions for medicinal products that are used in animals. In Austria, the relevant laws are the Austrian Medicines Act and the Veterinary Medicines Control Act (TAKG). However, this and existing national legislation in other EU countries will be immediately replaced by Regulation (EU) 2019/6 on veterinary medicinal products in January 2022 . In Switzerland, the Therapeutic Products Act deals jointly with human and veterinary medicinal products and also contains special provisions for veterinary medicinal products in Section 7. In addition, there are subordinate legal provisions in all countries.

Veterinary medicinal products can use the abbreviation ad us. vet. wear, as an abbreviation of the Latin ad usum veterinarium ("for use on animals"). They must be marked with the note "For animals". The animal species for which the veterinary medicinal product is intended must also be indicated.

In principle, a drug may only be used on animals if it is approved for the respective animal species and the disease to be treated; It is irrelevant whether the animals are domestic or farm animals. For example, a drug approved only for dogs may not be used in cattle . The use within one animal species can also be further restricted in that the approval only applies to dairy cows or only to calves .

Special features of veterinary medicinal products

Legal peculiarities for veterinary medicinal products are largely based on the fact that many animals are used to obtain food. For reasons of consumer protection , pharmaceuticals must be used with particular care in food-producing animals; certain pharmaceuticals are not even allowed.

Food-producing animals are:

waiting period

For such drugs that are used on food-producing animals, a waiting period must be observed before food is obtained (in Switzerland it is called a withdrawal period).

According to Directive 2001/82 / EC, the waiting time is the time that has to be observed after the last administration of a drug to an animal until the time of the production of food from this animal and which ensures that any residues do not exceed certain maximum levels for pharmacologically active substances exceed. The maximum permissible quantities are specified in Regulation (EU) No. 37/2010 .

This is to ensure that consumers of food of animal origin are not harmed by drug residues.

If no waiting time is specified for a veterinary medicinal product - for example, because it is used outside of the authorized use ("repurposed") - according to Directive 2001/82 / EC, the minimum waiting time for eggs and milk: 7 days, for meat from Poultry and mammals, including their fat and offal: 28 days, and for the edible tissues of fish: the number of days corresponding to the result of dividing the number 500 by the water temperature (in degrees Celsius ). The Commission can also set other waiting times. For the meat of horses that have been treated with funds from a special “positive list” adopted by the EU Commission , the waiting time is 6 months. There is no waiting period for certain homeopathic medicines . The same deadlines apply in Switzerland.

Residue check

In the case of pharmaceuticals for food-producing animals, in addition to clinical testing , residue testing is also important, i.e. H. the measurement of any drug residues in animal after treatment. With the results of the residue check, the pharmaceutical company proves that the waiting time to be observed is sufficient for the animal organism to break down and excrete the medicinal substance until residues of the veterinary medicinal product used are at most present in harmless traces and below the maximum permitted quantities. Food may no longer be obtained from animals used in clinical trials or from animals used in residue tests.

Medicated feed

In the case of larger animal herds, it may be appropriate to treat the entire herd in the same way instead of treating each animal individually, for which purpose the veterinary medicinal products are administered with the feed . For this purpose, there are veterinary drugs in ready-to-feed form: the feeding drugs, which are made from drug premixes and compound feed. Medicated feed requires a prescription and may only be made from approved premixes. In Germany, only companies with a corresponding manufacturing license are allowed to process premixes into medicated feed; they are sold directly to the animal owner . Veterinarians, on the other hand, are not allowed to dispense medicated feed.

In Austria, on the basis of the legal basis of the Veterinary Medicines Control Act, agricultural operations can also be entitled to produce medicated feed for specific treatment needs of their own livestock. The production must be reported to the district administrative authority and take place under the guidance of the treating veterinarian.

Manufactured and sold by veterinarians

Veterinarians in Germany have the right to dispense and are allowed to manufacture, store and dispense medicines themselves for the use of the animals they treat. For this purpose, you must operate a veterinary house pharmacy , whereby the provisions of the Medicines Act and the Ordinance on Veterinary House Pharmacies (TÄHAV) must be observed. As a rule, they obtain their veterinary medicinal products directly from the wholesaler or manufacturer.

The veterinarian may only dispense the required amount of the veterinary medicinal product with precise treatment instructions for a specifically necessary treatment. It is not allowed to dispense pharmacy or prescription-only products to keep the pet owner in stock for a possible need (“just in case”). Even more extensive quantity restrictions apply to prescription-only veterinary medicinal products for food-producing animals: Here, the veterinarian may only dispense the amount that is needed for treatment in the following 31 days (for antibiotics for systemic use: in the following 7 days), unless the Technical information expressly provides for a longer period of use. Thereafter, if necessary, the treatment can only be continued after a new examination.

In Austria, too, veterinarians can dispense medicinal products for the animals they treat; the requirements described in the Veterinary Act must be observed.

Reallocation

If there is no approved drug for the treatment of an animal's disease, it is called a therapeutic emergency . The veterinarian then has the option of selecting a medicinal product that is approved for a different indication or another animal species (" reassignment "). If necessary, he can also use medicinal products for human use. In the case of food-producing animals, only those medicinal substances may be used that are listed in Table 1 of Regulation (EU) No. 37/2010 ; they must be administered by the veterinarian himself or under his supervision.

Use of medicines on horses

Horses are generally considered to be food-producing animals. However, so that sport and leisure horses can be treated appropriately to the extent required and, on the other hand, the harmless quality of food produced from horses is guaranteed, there are special regulations for the use of drugs in horses. By a corresponding entry in the horse passport of the horse owner determines the classification of its horse as lebensmittellieferndes ( "to slaughter determined") or not lebensmittellieferndes animal ( "not intended for slaughter"). Only horses that are expressly excluded from slaughter in the horse passport are allowed unrestricted use of medicines in accordance with the usual regulations for pets, such as dogs and cats. Horses without an entry in the horse passport or without a horse passport at all may only be treated with drugs approved for food-producing animals. Horses that are listed as animals for slaughter can, in addition to the veterinary drugs approved for food-producing animals, also be treated with other agents that the EU Commission has listed in a "positive list" in accordance with the EU regulation on the creation of a register of animals for the treatment of equidae has compiled essential substances . After treatment with agents on the positive list, a waiting period of at least six months applies to the meat of these animals.

Immunological veterinary medicinal products

The manufacture, approval, testing and marketing of immunological veterinary medicinal products ("biologics") has been removed from the Medicines Act and is regulated by the Animal Vaccine Ordinance under the Animal Health Act. Immunological veterinary medicinal products require a prescription in Germany and may only be used on animals by veterinarians. Similar provisions also apply in Austria and Switzerland.

Documentation obligation

At the end of the supply chain, there are comprehensive documentation requirements for veterinary medicinal products that are not over-the-counter in accordance with the Animal Keeper Drug Application and Evidence Ordinance (THAMNV). In Germany, for example, veterinarians must provide full evidence of purchase and dispensing for these, and pharmacies for those who require a prescription. Livestock owners of food-producing animals must document the treatment of these animals and the purchase of the necessary medication, including medicated feed, for example in an inventory book. Even people who are not veterinarians but who use drugs professionally or commercially on animals must record their acquisition and whereabouts.

Pets

Over-the-counter drugs for use in pets such as ornamental fish, ornamental or songbirds, carrier pigeons, terrarium animals, small rodents , ferrets or, if they are not used to produce food, rabbits do not require authorization in Germany, Austria and Switzerland.

Dosage forms

Most of the dosage forms common in the field of human drugs are also found in veterinary drugs. There are also some special preparations for animals.

  • Intraruminal systems: capsules or tablets for oral administration in ruminants , which are tailored to the functional characteristics of a ruminant stomach. They have a particularly long residence time in the rumen and release the active ingredient or ingredients either continuously or in a pulsating manner over a certain period of time. They are administered with an application tube.
  • Preparations for intra- mammary use: sterile liquid or semi-solid agents that are introduced into the mammary gland through the teat canal .
  • Preparations for intra uterine use: liquid, semi-solid or solid means that are introduced into the uterus, as a rule, they exert their effect locally.

Another typical drug form for veterinary drugs are drug premixes, which are further processed into medicated feed. Such premixes of medicinal substance (s) and carrier substances must have special physical properties so that they can be easily processed and the active substances can be evenly distributed in the medicated feed. The proportion of the premix in the medicated feed should be at least 0.5%.

Pharmaceutical mail order business

The German Medicines Act prohibits mail-order sales of veterinary medicines that are not allowed to be sold outside of pharmacies. According to a BGH ruling, however, the prohibition does not apply to pharmacy-only medicinal products that are only used on (non-food-producing) pets, since neither the protection of human health is endangered nor animal welfare justifies a restriction of pharmacist activities at this point.

Veterinary drug directories

The classic directory of German veterinary drugs is the so-called purple list . The Institute for Veterinary Pharmacology and Toxicology in Zurich maintains a veterinary drug compendium as an online database for veterinary drugs in Switzerland.

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Individual evidence

  1. ↑ Products for healthy animals, Federal Association for Animal Health
  2. ↑ a b The Animal Health Industry 2014 (IFAH) ( Memento of the original from June 23, 2016 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / healthforanimals.org
  3. ↑ Paul Ehrlich Institute: Information for veterinarians
  4. ↑ M. Jung: New EU regulation for veterinary medicinal products , Pharmazeutische Zeitung, January 7, 2019.
  5. ↑ EU Veterinary Medicines Act - What's new? Federal Association of Practicing Veterinarians eV, May 31, 2019, accessed on July 30, 2020 .
  6. ↑ European Pharmacopoeia, Ph.Eur. 6th edition, basic work 2008, 6.0 / 1037
  7. ↑ Ref .: I ZR 210/07
  8. ↑ z. E.g .: Rudolf Petrausch (ed.): Lila Liste 2008/2009. The professional directory of German veterinary medicinal products. Delta medical publishing company mbh ISBN 978-3-88615-622-1
  9. ↑ Swiss veterinary medicinal product compendium

Legal norms

European Union
Germany
Austria
Switzerland

Web links