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Risk Management of Veterinary Antimicrobial Medicines

Ministry of Agriculture, Forestry and Fisheries (MAFF) tries to ensure proper use for veterinary antimicrobial products among veterinary drugs by implementing the following risk management countermeasures.

(1) System for drugs requiring examination

Article 18 of the Veterinary License Law (Veterinarians shall not issue a medical certificate or administer or prescribe deadly poisons, biological products or medicaments specified by MAFF Ordinance without examination by themselves.) imposes the veterinarian’s duty of examination for usage of veterinary antimicrobial products.

(2) System for Veterinary Medicinal Products (VMPs) requiring directions or prescription

Article 49, Paragraph 1 of the Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices applied mutatis mutandis in Article 83 of the Law (Proprietors of a pharmacy or distributors of medicaments shall not sell or provide medicaments specified by the MAFF to individuals other than those who receive prescriptions or directions from physicians, dentists or veterinarians without just cause.) prohibits selling veterinary antimicrobial products to individuals other than those who receive directions based on a veterinarian’s examination.

(3) Regulatory system for usage

Based on Article 83, 4, Paragraph 1 of the Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices (MAFF may establish criteria for veterinary drugs to be observed by users, for which meat, milk and other edible products from drug-administered animals which may threaten human health when the drugs are not used properly may be produced, on animals for which the drugs can be used, when to use if the drugs are used for the above animals and other considerations.), criteria (criteria for use) to be observed by users, including the animals for which the drugs can be used, dosage amount and use prohibition period, have been specified in "Restriction for the usage of VMPs and MPs (Ministerial ordinance No. 44, Series of 2013)".

(4) Handling as second-line drugs

MAFF makes efforts to avoid the selection of antimicrobial-resistant strains by promoting awareness that fluoroquinolones and third-generation cephalosporins, macrolides with 15 membered ring structure which are critical antimicrobials for human medication, should be used as second-line drugs only when other antimicrobial products are ineffective.

(5) Risk assessment by the Food Safety Commission and risk management countermeasures by MAFF

1) Risk assessment by the Food Safety Commission

The Food Safety Commission implements risk assessment for veterinary antimicrobial products used for food-producing animals (The effect of a antimicrobial-resistant strain selected by the usage of veterinary antimicrobial products on human health through food products is assessed.). These detailed risk assessments by drug product are implemented only in Japan.

2) Risk assessment and risk management countermeasures

For veterinary antimicrobial products for which assessment is completed by the Food Safety Commission, additional risk management countermeasures are to be implemented based on the assessment result according to the guidance for developing risk management countermeasures for veterinary antimicrobial products.
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