Chương III Thông tư 13/2016/TT-BNNPTNT: Nhãn thuốc thú y

Chapter III

LABEL OF VETERINARY DRUGS

Article 23. Types of veterinary drugs subject to labeling

1. Durgs which are domestically sold, exported or imported shall be labeled according to regulations in this Circular, except for cases specified in clause 2 of this Article.

2. If the foreign organization/individual importing drugs from Vietnam and request such drugs to be labeled according to a business contract and take responsibility for such request, then the organization/individual exporting drugs may follow such request, provided that such request does not falsify the substances of the drugs and is not contrary to laws of Vietnam and the importing country.

Article 24. Responsibilities for labeling of veterinary drugs

1. For veterinary drugs which are domestically manufactured for domestic sale, manufacturers shall be responsible for labeling thereof.

2. For veterinary drugs which are domestically manufactured for domestic sale, manufacturers shall be responsible for labeling thereof.

3. If the veterinary drugs having the certificate of free sale in Vietnam which are not exported and returned to be sale in Vietnam, the organization/individual selling such drugs shall carry out the labelling as prescribed in Article 26 of this Circular.

4. If the organization/individual responsible for the labelling of the drugs as prescribed in Article 10 of Decree No. 89/2006/ND-CP dated 30/8/2006 by the Government requests another organization/individual to carry out the labelling, the former organization/individual shall be still responsible for such labels.

5. For drugs imported into Vietnam which have the original labels unconformable to provisions of this Circular, the importing organization/individual shall attach supplementary labels to the products according to regulations in clause 3 Article 26 of this Circular before selling. The original labels shall be kept unchanged in this case.

6. Any organization/individual trading drugs shall comply which law provisions on intellectual property and shall take legal responsibility for the intellectual property towards information written on the label.

Article 25. Location, size, color of letters, symbols and images on the label

1. Location of labels of veterinary drug

Labels of veterinary drugs must be displayed (printed, stuck or attached) on their packages at a noticeable location, where the provided information can be seen easily and sufficiently with no need to disassemble the products, as prescribed in clause 1 Article 6 of Decree No. 89/2006/ND-CP.

2. Size of labels of veterinary drug

Any organization/individual responsible for labelling drugs shall itself determine the size of the label which must contain .sufficiently the information specified in Article 27 of this Cicular

3. Color of letters, symbols and images on the label

Color of letters, numberals, paintings, pictures, signs and symbols displayed on labels of drugs must be readable. For mandatory contents, letters and numerals must contrast with the background of the label as prescribed in Article 8 of Decree No. 89/2006/ND-CP.

Article 26. Languague used on labels of drugs

1. Compulsory contents of veterinary drug’s labels must be in Vietnamese, except the case specified in Clause 4 of this Article.

2. For veterinary drugs domestically manufactured and sold, their labels, apart from complying with the provisions of Clause 1 of this Article, may contain information in another language. Contents in another language must correspond those in Vietnamese. The size of letters in another language must not be bigger than that of contents in Vietnamese.

3. If labels of veterinary drugs imported into Vietnam do not contain or do not fully contain compulsory contents in Vietnamese, they shall be kept together with with supplementary labels showing compulsory information in Vietnamese. The original labels shall be kept unchanged.

4. The following contents may be presented in other languages of Latin origin:

a) Proprietary name, generic name or international nonproprietary names of drugs;

b) International names or scientific names of ingredients or ingredient quantities of goods, in case they cannot be translated into Vietnamese or their Vietnamese translations are meaningless;

c) Names and addresses of foreign manufacturing or franchising enterprises.

5. Contents displayed on veterinary drugs’ labels, including supplementary labels and package inserts, must be truthful, clear, precise and correctly reflect the substance of the goods.

Article 27. Contents of labels of veterinary drugs

1. A veterinary drug’s label must display fully the following contents:

a) Name of the drug;

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

c) Packing specifications;

d) 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;

dd) 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);

e) 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);

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

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

i) 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.

2. Other contents displayed on veterinary drug labels

Apart from compulsory contents specified in clause 1 Article 27 of thia Circular, a label may contain other information, for example, the quality standard code. Such information must be truthful and accurate and must not misrepresent the nature and effect of a drug as well as other information presented on the label.

3. The label of a veterinary drug material must contain the following information:

a) Name of the material;

b) Content or concentration (if any);

c) Standards of the material;

d) Net weight or volume;

dd) Number of batch, date of manufacture;

e) Expiry date, storage conditions;

g) Registration number (if any);

h) Name and address of manufacturer;

i) Origin of the material (except materials which are domestically manufactured and sold whose labels already contain addresses of manufacturers);

k) Name and address of importer (applicable to imported materials);

l) Remarkable signs.

4. The label of a veterinary drug pack must at least contain the following information:

a) Name of the drug;

b) Active ingredients, contents. For a veterinary drug containing 3 or fewer active ingredients, its label must fully indicate these active ingredients and their contents;

c) Number of batch, expiry date, registration number;

d) Name of manufacturer, which may be abbreviated, but must ensure the identity of the manufacturer.

A drug pack shall be put in a secondary packaging which has a label fully displaying the information specified in clause 1 Article 27 of this Circular.

5. Contents of labels of small-sized primary packagings.

a) The label of a veterinary drugs on a small-sized primary packaging with a special shape that cannot fully display compulsory information specified in clause 1 Article 27 of this Circular, must at least contain the following information: name if the drug; active ingredients, contents, for a drug containing 3 or fewer active ingredients, its label must fully indicate these active ingredients and their contents; volume or weight; number of batch, expiry date, registration number; name of manufacturer, which may be abbreviated, but must ensure the identity of the manufacturer;

b) Primary packagings of these veterinary drugs shall be put inside secondary packagings which have labels fully displaying the information specified in clause 1 Article 27 of this Circular.

Article 28. Labelling of veterinary drugs

1. Veterinary drug names

a) A veterinary drug shall be named by its manufacturer or trader. Such a name must not misrepresent the substance and effect of the drug. The letters for a drug name must be bold and prominent.

The label of a single-element proprietary drug must indicate the generic name or the international nonproprietary name of the drug right after the proprietary name;

b) A drug may be named after: the generic name; the international nonproprietary name (INN); proprietary name.

2. Composition of active ingredients, contents or concentrations

a) Composition of all active ingredients and excipients contained in a finished drug product shall be displayed according to regulations in clause 1 Article 18 of Decree No. 89/2006/ND-CP even when those materials change their forms in the manufacture process;

b) All active ingredients, contents or concentrations of the smalled dose or packing unit of every active ingredient, excluding component and contents of excipients, shall be displayed. Names of active ingredients shall be presented according to their generic names or international nonproprietary names;

c) Units of measurement

Units of quantitative measurement shall be presented on veterinary drug labels in their full or abbreviated forms. Units of active power may be used according to international practive for some special active ingredients.

3. Packing specifications

a) Packing specifications of a drug means the quantity, net weight or actual volume of a drug contained in a commercial packing;

b) Packing specifications shall be presented in natural numbers;

c) Packing indications of spme specific forms of veterinary drugs shall be presented as follows:

- For capsules: quantity of capsules, contents of active ingredients/capsules;

- For powder: weight;

- For liquid: real volumetric

- For gonadotropic drugs for animals and some other active ingredients: international unit (IU);

d) For a drug whose commercial packaging contains many packing units, the weight of each packing unit and the quantity of packing units must be presented.

4. Indication, route of administration, contraindication and withdrawa time

a) Indication for treatment of each animal species indicated on a drug label must match the effect of such drug.

b) Use instructions must conspicuously indicate the route of administration, dose and treatment duration;

c) Contraindication cases shall be specified for drugs with contraindication. For drugs without contraindication, the non-contraindication status shall be stated;

d) The indication, route of administration-contraindication for a drug may be presented in either of the following ways:

- Directly on the commercial packaging;

- In the package insert enclosed in the commercial packaging, for a drug whose label on the secondary packaging fails to display the drug's indication, route of administration and contraindication. In this case, the phrase “Chỉ dịnh, cách dùng, chống chỉ dịnh: xin dọc trong tờ hướng dẫn sử dụng” (See the package insert for indication, route of administration and contraindication) shall be printed on the label on the commercial packaging;

dd) Withdrawa time shall be specified for each animal species to be treated. In case the withdrawa time is not available, this shall be stated.

The withdrawa time must match the time indicated in the drug circulation registration dossier.

5. Dosage forms, registration numbers, batch numbers, date of manufacture, expiry date, storage conditions

a) Dosage forms of a drug as capsule, powder, injection solution, injection suspension, powder for injection, or oral solution shall be presented;

b) The registration number, which is the code of a veterinary drug granted by the Animal Health Department to certify the registration for sale of such drug in Vietnam shall be presented;

c) The batch number shall be presented as “Số lô sản xuất” or “Số lô SX”. The batch numbers structure shall be prescribed by the manufacturer;

d) The date of manufacture, expiry date and storage duration shall be specified as follows: the date of manufacture and expiry date shall be presented on the label fully or in abbreviation in upper case letters as NSX, HSD in the format [dd/mm/yyyy] of the calendar year. The numberals presenting a date must be displayed on the same line according to regulations in Article 16 of Decree no. 89/2006/ND-CP. When it is impossible to display “NSX”, “HSD” together with the numbers indicating fully the date the label must so indicate. When a label displays the date of manufacture NSX and expiry date HSD in a foreign language, the supplementary label must display the date of manufacture and expiry date or the phrase “NSX/HSD xem Mfg Date/Exp Date trên bao bì” (See Mfg Date/Exp Date for NSX/HSD).

dd) Storage conditions means climate factors to ensure the unchanging of quality of drugs. Necessary storage conditions shall be presented on the drug label. For example: Store in a dry and cool place at 30^oC or below.

6. Remarkable signs

a) For injection drugs or powder for injection, the administration shall be specified. Administrations of drugs may be abbreviated to tb (tiêm bắp - intramuscular injection), tdd (tiêm dưới da - subcutaneous injection), tm (tiêm tĩnh mạch - intravenous injection);

b) For eyedrops, the phrase “Thuốc tra mắt” (ophthalmic drugs) shall be displayed;

c) For drugs for external use, the phrase “Thuốc dùng ngoài” (For external use) shall be displayed;

d) For drugs in ampoules for oral use, the phrase “không dược tiêm” (Not for injection) shall be displayed;

dd) For some chemicals used in animal healthcare, their typical qualitative indicators shall be displayed. For inflammable, explosive, toxic or corrosive chemicals, respective warnings shall be displayed. For chemicals in pressure containers, container numbers, capacity and warnings shall be displayed;

e) Warnings (if any) shall be displayed on drug labels to ensure the safety for drug administrator;

g) Presentation of remarkable signs

Remarkable letters and signs shall be conspicuous and bold to be easily seen. If a drug has multiple remarkable signs, such remarkable signs shall be fully presented.

7. Name and address of organization/individual responsible for the drugs

a) Name and address of organization/individual responsible for the drugs must not be abbreviated;

b) Name and address of organization/individual responsible for the drug shall be presented according to regulations in Annex XXXV enclosed with this Circular;

c) A label containing the name and address of the distributor must display such name and address in the same place with the manufacturer's and of a size not bigger than the manufacturer's;

d) The name of the organization or individual responsible for a drug shall be printed fully as indicated in legal documents on its establishment. Its transaction name may be printed, but of a size not bigger than the full name;

dd) Addresses of manufacturer, packaging establishments, franchise manufactures or subcontract manufacturers including house number, street (village), commune (ward, township), district (town, provincial city) and province (central-affiliated cities) shall be displayed.

8. Origin of veterinary drugs

a) For imported drugs: The phrase “sản xuất tại” (manufactured in) or “xuất xứ” (origin) followed by the name of country or territory of manufacture shall be presented;

b) For domestically manufactured and sold drugs whose label already indicates the place of manufacture, the presentation of the drug's origin is not required;

c) The origin of a drug shall be presented on its secondary and primary packagings.

9. Use instructions

a) Veterinary drugs labeled under this Circular must have a package insert in Vietnamese. The contents of this insert may be printed on the primary packaging or intermediary label instead of a separate insert.

The size and color of letters printed on the package insert must be big and conspicuous to the naked eye.

b) Content of the package insert shall be conformable to regulations in Annex XXXVI enclosed with this Circular.

10. Presentation of supplementary labels

A supplementary label shall be attached to the secondary packaging of a veterinary drug and must not hide from view contents of the original label. Contents of a supplementary label must not cause misunderstanding about those of the original label and the labeling organization/individual shall take legal responsibility for the accuracy and truthfulness of additional contents. A supplementary label shall be presented as follows:

a) For labela with sufficient space, all compulsory contents shall be specified according to regulations in clause 1 Article 27 of this Circular;

b) If the supplementary is small and cannot fully display compulsory contents, at least the following information shall be presented: name of the drug; active ingredients, content or concentration; name of organization or individual responsible for the drug; registration number; packaging specifications; date of manufacture, number of batch; origin of the drug.

Other remaining compulsory information shall be presented in the package insert. In such case the supplementary label must contain the phrase: “Các thông tin khác dề nghị xem trong tờ hướng dẫn sử dụng kèm theo” (See the package insert for other information) and the contents on the package insert indicated on the supplementary label shall be regarded as part of the supplementary label;

c) When the original label of a drug is presented in a Latin-originated language and contains the information below, the translation into Vietnamese and presentation on a supplementary label of such information is not required: proprietary name, generic or international non-proprietary name of the drug; international non-proprietary name or scientific name of each ingredient of the drug when it is impossible to translate into Vietnamese or such translation bear no meaning; name and address of foreign manufacturer or manufacture franchising grantor.