THE MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT
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SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No. 03/2009/TT-BNN
Hanoi, January 14, 2009
 
 
CIRCULAR
 
ON LABELING VETERINARY DRUGS
Pursuant to the April 29. 2004 Animal Health Ordinance; and the Government's Decree No. 33/2005/ND-CP of March 15, 2005, detailing a number of articles of the Animal Health Ordinance;
Pursuant to the Government's Decree No. 01/ 2008/ND-CP of January 3, 2008, defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural Development;
Pursuant to the Government's Decree No. 89/ 2006/ND-CP of August 30, 2006, prescribing contents, presentation and state management of labels of domestically circulated goods and exported and imported goods (below referred to as Decree No. 89/2006/ND-CP);
Pursuant to the Science and Technology Ministry's Circular No. 09/2007/TT-BKHCN of April 6, 2007, guiding a number of articles of the Government's Decree No. 89/2006/ND-CP of August 30, 2006, on goods labeling;
The Ministry of Agriculture and Rural Development prescribes the labeling of veterinary drugs, veterinary pharmaceutical materials, biological preparations, microorganisms and chemicals used in animal health, including aquatic veterinary drugs, (below referred to as veterinary drugs) as follows:
 
I. GENERAL PROVISIONS
 
1. Scope of regulation
a/ This Circular prescribes contents and presentation of labels of exported, imported or domestically circulated veterinary drugs.
b/ The following cases are not governed by this Circular:
- Veterinary drugs temporarily imported for re-export or for display at fairs or exhibitions and re-export later; transited goods or goods transported to/from border gates; non-trade imported veterinary drugs, donated drugs, veterinary drugs under research at research and manufacture establishments;
- Veterinary drugs imported for test or examination;
- Veterinary drugs imported for urgent control of epidemics or in other special cases;
- Veterinary drugs being presents or gifts or personal effects of people on entry or exit.
 
2. Subjects of application
Domestic and overseas organizations and individuals engaged in manufacture, franchised manufacture, subcontracted manufacture, division and re-packing (below referred to as manufacture), trading in, import and export of veterinary drugs shall comply with this Circular, the intellectual property law and other relevant legal documents.
 
3. Interpretation of terms
In this Circular, the terms below are construed as follows:
a/ Veterinary drug means a substance or compound originated from animals, plants, microorganisms, minerals or chemicals used for prevention, diagnosis or treatment of animal diseases or rehabilitation, adjustment or improvement of functions of bodily organs of animals, which includes pharmaceuticals, chemicals, vaccines, hormones, some other biological preparations and some microorganisms used in animal health.
b/ Proprietary name means a commercial brand named by a drug manufacturer, which is different from the original or international nonproprietary name.
c/ Drug label means written, printed or drawn words, drawings, images or signs which are directly printed on, or stuck, pinned or securely attached to, the commercial packaging of a drug to display necessary and essential information as a basis for users' selection and proper use and for examination and control by functional agencies.
d/ Labeling of a drug means the presentation of basic and necessary information on a drug on its label for users' information, selection, consumption and use; for goods promotion by manufacturers and traders; and for examination and control by functional agencies.
e/ Original label of a drug means the first label printed, stuck, pinned or securely attached to the commercial packaging of the drug after it is packed in a production chain.
f/ Supplementary label means a label displaying compulsory information translated from a foreign language into Vietnamese and supplementing compulsory information in Vietnamese as required by law, which the original label does not contain.
g/ Commercial packaging of a drug means the packaging which contains the drug and is circulated together with the drug, comprising two types:
- Direct packaging, which means the packaging in direct contact with and directly containing the drug;
- Outer packaging, which means the packaging used for packing one or a number of drug units contained in direct packagings.
h/ Name and address of the organization or individual responsible for a drug means the name and address of the manufacturer, exporter, importer, entrusted exporter or entrusted importer of the drug.
i/ Packing specifications of a drug means the drug quantity in net weight, actual volume or cardinal number.
j/ Manufacture lot number means the code in numbers or letters or a combination of numbers and letters to enable recognition, and tracing back of the history of, a drug lot, covering all stages of manufacture, quality control and distribution of such lot.
k/ Date of manufacture means the point of time when the manufacture, processing, bottling, packing or another form of finishing the final manufacture stage of a drug lot is completed.
l/ Expiry date means the point of time past which a drug may not be used.
m/ Origin of a drug means the country or territory where such drug is manufactured, or processed at the final stage, for a drug manufactured through many stages in different countries or territories.
n/ Use and storage instructions means information relating to the use, and necessary conditions for use and preservation, of a drug; warnings; and remedies for hazardous incidents, guiding users how to safely and properly use such drug.
"Use and storage instructions" insert means a document attached to a drug's commercial packaging, which presents use instructions and other information under regulations.
 
4. Veterinary drugs subject to labeling
a/ Domestically circulated, exported and imported veterinary drugs shall be labeled under this Circular, except the case specified at Point b of this Clause.
b/ When a foreign importer of a Vietnamese drug requests the drug exporter to label such drug under their purchase and sale contract and takes responsibility for its request, the drug exporter may do so provided that such labeling does not misrepresent the nature of the drug and contravene the laws of Vietnam and the importing country.
 
5. Veterinary drug label positions
The label of a veterinary drug shall be placed (printed, stuck, pinned or attached) on the commercial packaging of the drug at a position from which all of its compulsory contents can be easily noticed without having to disassemble the drug under Clause 1, Article 6 of Decree No. 89/2006/ND-CP.
 
6. Veterinary drug label sizes
Organizations and individuals responsible for drug labeling may decide on label sizes, but shall ensure the full presentation of compulsory contents under Part II of this Circular.
 
7. Colors of letters, signs and images shown on veterinary drug labels
The color of letters, numerals, drawings, images, signs and symbols shown on a veterinary drug label must be conspicuous. For compulsory contents, the color of letters and numerals must contrast the label's background color as prescribed in Article 8 of Decree No. 89/2006/ND-CP.
 
8. Language presented on veterinary drug labels
a/ Compulsory contents of a veterinary drug label shall be presented in Vietnamese, except the cases specified at Point d of this Clause.
b/ Contents of the label of a domestically manufactured and circulated veterinary drug may, apart from complying with Point a of this Clause, be concurrently presented in other languages. Contents in other languages must match those in Vietnamese. Sizes of letters for contents in other languages must not be bigger than those in Vietnamese.
c/ An imported veterinary drug whose original label does not contain or not fully contain compulsory contents in Vietnamese must have a supplementary label displaying compulsory contents in Vietnamese together with its original label.
d/ The following information may be presented in other languages of Latin origin:
Proprietary name, original name or international non-proprietary name of a drug;
International non-proprietary names or scientific names of ingredients, quantitative ingredients of a drug when it is impossible to translate these names into Vietnamese or such translation bears no meaning;
Name and address of the foreign manufacturer or grantor of manufacture franchising.
e/ Information presented on a veterinary drug label, including its supplementary label, and the "use instructions" insert must be truthful, conspicuous and accurate and true to the drug's nature.
 
9. Veterinary drugs labeling responsibilities
a/ Manufacturers of Vietnamese veterinary drugs for domestic sale shall label their drugs.
b/ Manufacturers of Vietnamese veterinary drugs for export and exporters shall label such drugs.
c/ When a for-export veterinary drug cannot be exported and is circulated domestically, the distributor of such drug shall label it under Clause 8. Part I of this Circular.
d/ When an organization or individual responsible for labeling a veterinary drug under Article 10 of Decree No. 89/2006/ND-CP requests another organization or individual to label such drug, the former shall still take responsibility for the label of its drug.
e/The importer of a drug whose original label fails to comply with this Circular shall make a supplementary label under Point c. Clause 8, Part I of this Circular before circulating the drug together with the original label.
f/ Drug manufacturers and traders shall comply with the intellectual property law and take responsibility before law for intellectual property-related matters concerning drug label contents.