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.
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