Vietnam: If it is impossible to specify all required information on secondary package labels of drugs, how to handle this case?

Main Content

• If it is impossible to specify all required information on secondary package labels of drugs in Vietnam, how to handle this case?
• What are the instructions for expressing secondary labels of drugs in case it is impossible to specify all required information on small-sized secondary labels of drugs in Vietnam?
• What are the regulations on the primary package labels of drugs and medicinal ingredients in Vietnam?

If it is impossible to specify all required information on secondary package labels of drugs in Vietnam, how to handle this case?

Pursuant to Clause 4 Article 7 of Circular 01/2018/TT-BYT as follows:

Secondary package labels of drugs and medicinal ingredients

1. The secondary package label of drugs must contain the compulsory information below:

a) The drug name;

b) Dosage form;

c) The composition of the drugs, contents, weights or concentrations of active ingredients or herbal ingredients;

d) Package contents;

dd) Indications, usage instructions and contraindications;

e) Registration number or import license number (if any);

g) Batch number, manufacturing date, expiry date, quality standards and storage conditions;

h) Precautions and recommendations;

i) Name and address of the manufacturer;

k) Name and address of importer (for imported drugs);

l) Drug origin.

2. The secondary package label of medicinal ingredients (including herbal ingredients, traditional ingredients, semi-finished drugs and semi-finished herbal medicines) must contain the compulsory information below:

a) Name of medicinal ingredients;

b) Weight or volume of medicinal ingredients contained in the smallest package unit;

c) Quality standards of medicinal ingredients;

d) Registration number or import license number (if any);

dd) Batch number, manufacturing date, expiry date and storage conditions;

e) Name and address of the manufacturer of medicinal ingredients;

g) Name and address of importer (for imported medicinal ingredients);

h) Origin of medicinal ingredients.

3. Labels of controlled medicinal ingredients (including controlled semi-finished drugs):

In addition to compulsory information specified in Clause 2 of this Article, the following texts must be specified on secondary labels of medicinal ingredients which are active ingredients, herbal ingredients or semi-finished drugs containing active ingredients or herbal ingredients on the Lists of narcotic active ingredients, psychotropic ingredients, drug precursors, toxic medicinal ingredients, toxic herbal ingredients and radioactive medicinal ingredients: “Nguyên liệu gây nghiện” (“Narcotic active ingredients”), “Nguyên liệu hướng thần” (“Psychotropic ingredients”), “Nguyên liệu tiền chất làm thuốc” (“Drug precursors"), “Nguyên liệu độc” (“Toxic medicinal ingredients”), “Dược liệu độc” (“Toxic herbal ingredients”) or “Nguyên liệu phóng xạ” (“Radioactive medicinal ingredients”).

The text “Nguyên liệu gây nghiện”, “Nguyên liệu hướng thần”, “Nguyên liệu tiền chất làm thuốc”, “Nguyên liệu độc”, “Dược liệu độc”, “Nguyên liệu phóng xạ” must be printed bold type in box and on the main side of the label on which the name of medicinal ingredients is specified.

4. If the secondary package label cannot contain all compulsory information prescribed in Clause 1 of this Article, the information specified in Point dd Clause 1 of this Article may be briefly summarized by the following text: “Chỉ định, cách dùng, chống chỉ định và các thông tin khác: xem trong tờ hướng dẫn sử dụng thuốc kèm theo” (“Please refer to the package insert for indications, usage instructions, contraindications and other information”).

Thus, according to the above regulations, in case it is impossible to specify all required information on secondary package labels of drugs as prescribed, it may be briefly summarized by the following text: “Chỉ định, cách dùng, chống chỉ định và các thông tin khác: xem trong tờ hướng dẫn sử dụng thuốc kèm theo” (“Please refer to the package insert for indications, usage instructions, contraindications, and other information”).

What are the instructions for expressing secondary labels of drugs in case it is impossible to specify all required information on small-sized secondary labels of drugs in Vietnam?

Pursuant to Clause 2, Article 10 of Circular 01/2018/TT-BYT as follows:

Secondary labels

1. The secondary label shall contain every compulsory information which is not written on the original label in the Vietnamese language as prescribed in Article 7 of this Circular.

2. If the secondary label is so small that it cannot contain compulsory information as specified in Clause 1 of this Article 7, certain compulsory information may be written as follows:

a) Indications, usage instructions, contraindications and other information: Please refer to the package insert;

b) The way to find out the information about manufacturing date, expiry date and batch number printed on the original label must be available;

c) Registration number or import license number may not be specified but the information about registration number or import license number (if any) must be specified before drugs are sold on the market.

Thus, according to the above regulations, for small-sized secondary labels of drugs in Vietnam that cannot contain compulsory information, the following information shall be specified:

- Indications, usage instructions, contraindications, and other information: Please refer to the package insert;

- The way to find out the information about the manufacturing date, expiry date, and batch number printed on the original label must be available;

- Registration number or import license number may not be specified but the information about registration number or import license number (if any) must be specified before drugs are sold on the market.

What are the regulations on the primary package labels of drugs and medicinal ingredients in Vietnam?

Pursuant to Article 9 of Circular 01/2018/TT-BYT, the regulations on the primary package labels of drugs and medicinal ingredients in Vietnam are:

- The primary package label of drugs must contain the following compulsory information:

+ The drug name;

+ The composition of the drugs, contents, weights or concentrations of active ingredients or herbal ingredients;

+ Batch number;

+ Expiry date;

+ Name of the manufacturer.

- Primary package labels of medicinal ingredients:

If the secondary package label of medicinal ingredients contains sufficient compulsory information as regulated in Clause 2 and Clause 3, Article 7 of Circular 01/2018/TT-BYT, the primary package label may be exempted provided that the medicinal ingredients are not divided for retail.

- If there is no secondary package, primary package labels of drugs and medicinal ingredients must contain sufficient information of secondary package labels as regulated in Article 7 of Circular 01/2018/TT-BYT.