What contents are mandatory to be displayed on a veterinary drug’s label in Vietnam?

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Question date: 24/03/2023

Hello Lawnet. I want to ask about regulations on management of veterinary drug. What contents are mandatory to be displayed on a veterinary drug’s label in Vietnam? Thank you!

    • Pursuant to Clause 1 Article 27 of the Circular 13/2016/TT-BNNPTNT, a veterinary drug’s label must display fully the following contents:

      - Name of the drug;

      - Composition and quantity of active ingredients (content or concentration);

      - Packing specifications;

      - Indications, route of administration and contraindications of drugs; withdrawa time (if any) to use eggs, meat or milk for each animal species to be treated;

      - Dosage form, registration number, number of batch, date of manufacture, expiry date and the phrase “Chỉ dùng trong thú y” (for use in animal healthcare only);

      - Remarkable signs: For schedule-A toxic veterinary drugs, to add the phrase (in black): “không dùng quá liều quy dịnh” (Do not overdose); for schedule-B toxic veterinary drugs, to add the phrase (in red) “không dùng quá liều quy dịnh” (Do not overdose);

      - Name and address of organization/individual responsible for the drug;

      - Origin of the drug, except for veterinary drugs domestically manufactured and sold whose labels already display the place of manufacture;

      - Use and storage instructions

      When it is impossible to present all the above information on a label, the information specified in points a, b, c, dd, e, g and h of this Clause shall be presented. Other compulsory information shall be presented in a supplementary label or the package insert. In this case, the label must indicate where such information is presented.

      Above are contents which are mandatory to be displayed on a veterinary drug’s label in Vietnam.

      Best regards!

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    "This English translation is for reference purposes only and not a definitive translation of the original Vietnamese texts"

    LEGAL BASIS OF THIS SITUATION
    • Article 27 of the Circular 13/2016/TT-BNNPTNT Download
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