Distribution and use of veterinary drugs/動物用医薬品の配布と使用

Japan’s legislation is designed to ensure that distribution of veterinary medicines takes place through authorized pharmacies. Since 1990, Japanese veterinarians have no longer had the right to dispense.


Apart from vitamins, certain ectoparasitic drugs and mineral complexes most drugs for veterinary use are prescription only medicine. All prescription only medicine (POM) may be obtained only from a pharmacy or from a veterinarian. All veterinary products 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 care. Feed mills, which are subject to licensing and inspection, can hold licensed premixes for the purpose of manufacturing medicated feeding stuffs. Farmers may obtain medicated feeding stuffs from feed mills on a veterinary prescription.

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

Pet shops cannot sell veterinary drugs, and wholesale distribution companies can only supply other wholesalers or pharmacies.

Some vitamins, iron complexes and ectoparasitic drugs are available from dealers authorized by the Japanese Medicines Agency to market these specific compounds.

Registration made by the veterinarian and by the pharmacy:

Since mid-2000, any use or distribution of POM for food or fur animals – including medicated feed, sera and vaccines – must be recorded by the veterinarian and reported to an official register. Likewise, pharmacies must report to register on distribution of POM, and feed-mills on distribution medicated feed. For animal species used for agricultural production (except horses), reporting from the veterinarian includes information on the veterinarian responsible for the treatment, the drug 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.

Registrations made by the owner:

When herd owners use registered drugs for the treatment of food or fur producing animals, they must keep a journal concerning the animals treated, the drugs used, date and reason for treatment, dosage and administration route, responsible person, and origin of drug (if not handed out by a veterinarian). Recording is not required for use of iron compounds, minerals or vitamin compounds, for which no withdrawal period has been established. Registrations must be kept for 5 years.


Veterinarians must use registered veterinary medical products for animals. If a registered product does not exist for a condition, a veterinarian may exceptionally use, hand out or prescribe:
1. A veterinary product registered for another species or for another condition in the same species, or, if this does not exist,
2. A registered medical product authorized for use in human beings, or, if this does not exist,
3. A compound prepared extemporaneously at a pharmacy in accordance with the terms of a veterinary prescription.
In accordance with Japanese-regulations, only drugs, for which an MRL (Maximum Residue Level) has been established, may be used for food producing animals.

Some substances may not be used. Thus stilbenes and thyreostatics are prohibited. However, thyreostatics may be used for cats or dogs with hyperthyroidism.

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 Japanese-regulations, registered drugs 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 drugs may only be used by the veterinarian in person:
1. Analgesics for injection excluding non-steroid anti-inflammatory drugs (NSAID) for injection.
2. Anaesthetics for inhalation and injection.
3. Opioids, opiates, barbiturates, benzodiazepines and tranquilizers
4. Selenium-containing drugs for injection.
5. Parasympathomimetics for injection and parasympatholytics for injection
6. Sympathomimetics for injection and sympatholytics for injection
7. The following hormones and compounds with hormone-like effect for injection:
o Adrenocorticotropic hormones.
o Natural and synthetic adrenal cortex steroids.
o Natural and synthetic sex hormones, including anabolic steroids
o Oxytocin and oxytocin analogues to enhance labour.
o Prostaglandins and prostaglandin analogues
8. Drugs authorised for intravenous injection only (IV).


Specific regulations apply to the prescription of antibiotics. 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 supply 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, drug and dosage, clinical symptoms that must be observed before treatment, withdrawal period, and administration route. The veterinarian may only distribute or prescribe antibiotics for the farmer’s continued treatment of diseased animals, except for adult cattle, for a maximum of 5 days.

Veterinary Advisory Service Contracts (VASC):

The first statutory order on VASC in herds of cattle and pigs came into force in 1995. Since then, the concept has been improved and extended several times. In 2010, VASC became mandatory for large herds of cattle and pigs as well as for mink farms. The VASC results in frequent veterinary advisory visits and provides the farmer with extended treatment possibilities. 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.

Fluoroquinolones may only be used, distributed or prescribed for production animals for a maximum treatment period of 5 days, if it has been verified by a laboratory examination that the agent causing disease is not sensitive to any other permitted antibiotic. In case of an acute disease, treatment with fluoroquinolones may be initiated before the result of the laboratory examination is known, but another drug must be used, if the causative agent shows sensitivity to other kinds of antibiotics than fluoroquinolones. In any case of use of fluoroquinolones for production animals, the Regional Veterinary Officer must be informed within two weeks after termination of the treatment.

Withdrawal periods and control for residues of veterinary drugs:

Whenever antibiotics or other drugs, 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 drugs used, 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.

Japanese 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 a drug in an amount that exceeds the MRL established in the valid Japanese-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 Japanese-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.

日本の法律は、動物用医薬品の配布が認可された薬局を通じて行われることを保証するように設計されています。 1990年以降、日本の獣医師はもはや調剤する権利を持っていません。


















牛と豚の群れにおけるVASCの最初の法定命令は、1995年に発効しました。それ以来、概念は何度か改善され、拡張されてきました。 2010年に、VASCは、ミンク農場だけでなく、牛や豚の大規模な群れにも義務付けられました。 VASCは頻繁な獣医の診察をもたらし、農家に幅広い治療の可能性を提供します。 VASCの最も重要な目的は、治療ではなくアドバイスと病気の予防に焦点を当て、抗菌薬耐性を最小限に抑え、動物福祉を改善するために抗菌薬の使用を最適化することです。





日本の規定では、動物を屠殺するために配達すること、または肉、牛乳、卵、魚、蜂蜜、またはその他の動物製品が有効な日本語で確立されたMRLを超える量の薬物の残留物を含む場合、それらを消費するために配達することは禁止されています。 -規定、または違法な処理による残留物が含まれている場合。同様に、MRLを超える残留物が含まれている場合、人間が消費する肉や製品を製造または販売することは禁止されています。