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Veterinary Drug Labels And Management Approaches

Original Language Title: 兽药标签和说明书管理办法

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(October 31, 2002 the Department of agriculture released 22nd) Chapter I General provisions article to strengthen the veterinary supervision and management, specification labels and contents, printing and use of veterinary drugs, ensure the safety of veterinary drugs used effectively, in accordance with the regulations on the management of veterinary drugs, these measures are formulated.
    II Department of agriculture in charge of the nation's veterinary drug labels and management, animal husbandry and veterinary Administrative Department under local people's Governments at or above the county level supervisor's District veterinary drug labels and management.
    Article III production in China, operation, use of veterinary drug labels and must comply with the regulations.
    Chapter two basic requirements for veterinary drug labels fourth veterinary drug products (except API) must use both the inner label and outer label.
    Labels must indicate within the fifth animal identification, veterinary drug names, indications (or functions and indications), content/package sizes, the approval or the registration of veterinary drug import license certificate number, production date, batch number, expiry date, manufacturer information, and so on.
    Ampoules, vials, injection or oral administration of products due to package size restrictions can not be annotated above all content, it may be appropriate to reduce the project, but you must indicate the name of veterinary drugs, content specifications, the production lot number.
    Sixth package labels must indicate the animal identification, animal names, ingredients, indications (or functions and indications), usage and dosage, content/package sizes, approval number and the registration of veterinary drug import license certificate number, production date, batch number, date of expiry, withdrawal time, storage, packaging, quantity, manufacturer information, and so on.
    Article seventh veterinary drug labels should indicate the veterinary drug names, package specifications, production batch number, production date, expiry date, storage, approval number, transportation considerations or other mark, manufacturer information, and so on.
    Eighth have special requirements for storage must be prominently marked on the label. Nineth chronologically marking the validity of veterinary drugs.
    Year is expressed in four digits, month in two digits, such as "valid until September 2002", or "valid until 2002.09."
    Third chapter veterinary drugs Manual of basic requirements tenth article beast with chemical drug, and antibiotics products of unilateral, and compound and the West compound preparations of manual must indicate following content: beast with identifies, and veterinary drugs name, and main ingredients, and characters, and pharmacological role, and indications (or function and attending), and usage and dosage, and bad reaction, and note matters, and stopped drug period, and topical insecticidal drug and he on human or environment toxic harmful of abandoned packaging of processing measures, and validity, and content/packaging specifications, and storage, and approved paper,, and production enterprise information,.
    11th must indicate the following details in the veterinary medicine: animal identification, animal names, main ingredients, characteristics, functions and indications and usage and dosage, adverse reactions, precautions, availability, specifications, storage, approval number, manufacturer information, and more.
    12th article beast with biological products manual must indicate following content: beast with identifies, and veterinary drugs name, and main components and the content (type, and strains and the live vaccine of minimum live bacteria number or virus drops degrees), and characters, and vaccination object, and usage and dosage (frozen dry vaccine must marked diluted method), and note matters (including bad reaction and emergency measures), and validity, and specifications (capacity and Toufen), and packaging, and storage, and abandoned packaging processing measures, and approved paper,, and production enterprise information,. The fourth chapter 13th labels and management of veterinary drugs veterinary drugs labels and must be in accordance with the veterinary drug approval, by the Ministry of agriculture or animal husbandry and veterinary administrative departments at the provincial level for approval before use.
    Content changes should be interpreted according to the application procedures and approval procedures.
    14th veterinary drug labels and instructions must be in accordance with the provisions of the uniform requirements for printing text and images are not allowed to join any unapproved content.
    15th veterinary drug labels and content must be true and accurate, and shall not be false or exaggerated, nor any printed text with publicity, advertising, color and logo.
    16th veterinary drug labels and content shall not exceed the provisions or delete items; shall be printed without permission of the patent, veterinary drug GMP and trademark identification. Article 17th veterinary drug labels and text must be used by the Chinese, and use of the State language work Committee announced the current standardized Chinese characters.
    Foreign control as needed.
    18th according to need, barcodes can be used on the labels of veterinary drugs; approved patented products, marking the patent marks and patent numbers and marked patent license types registered trademarks should be printed on the labels and the upper-left or lower-right corner; of veterinary drug GMP certificate has been, in accordance with the veterinary drug GMP logo proper use of veterinary drugs GMP identifies the relevant provisions.
    Article 19th handwriting of veterinary drug labels and instructions must be clearly distinguishable, animal identification and external use label should be clearly visible without printing off or pasted is not strong, and not with the paste, cut, as modified or supplemented.
    20th veterinary labels and instructions on product function and use items shall not violate the provisions of the statutory standards for veterinary drugs, and may not have extended efficacy, application-wide content; its usage and dosage, withdrawal time, the validity period of the project must be consistent with the statutory standards for veterinary drugs, and uses the normative term in line with national standards for veterinary drugs. Article 21st veterinary drugs veterinary drugs must be identified on labels and generic names, simultaneously identified trade names. Trade names shall not be generic names to write, there should be some gap between branches.
    Proportion of characters for common name and trade name shall not be less than 1:2 (area), and shall not be less than the registered trademark words. 22nd packaging of veterinary medicine the smallest sales unit must be printed or comply with packaging labeled provides content labels and instructions.
    Veterinary medicine shall be printed on the outer box outer packaging labels or paste.
    23rd a contravention of this regulation, in accordance with the relevant provisions of the regulations on the management of veterinary drugs for punishment.
    Fifth chapter supplementary articles article 24th of this approach is the meaning of the following terms: veterinary drugs generic name: national standards, the Ministry of agriculture to industry standards, local standards and official name of import registration of veterinary drugs.
    Veterinary drug product name: refers to a proprietary brand name of veterinary drug products.
    Labels: refers to direct contact with the label on the packaging of veterinary drugs.
    Packaging labels: refers to direct contact on the inner packaging outer packaging label.
    The smallest sales unit of veterinary drugs: minimal packaging refers to listed for the direct sales of veterinary drugs.
    Veterinary drugs Description: refers to contain veterinary drugs active ingredients, efficacy, use, as well as considerations of basic information, such as technical information.
    Manufacturer Info: includes business name, zip code, address, telephone number, fax number, email address, Web site, etc.
    25th article this way by the Ministry of agriculture is responsible for the interpretation.
                  26th article of the rules take effect on March 1, 2003.