Vietnam: New points regarding precautions and recommendations specified on drugs

According to Circular No. 01/2018/TT-BYT of the Ministry of Health of Vietnam, the following precautions and recommendations must be written on labels and package inserts of drugs:

- The text ““Để xa tầm tay trẻ em” ("Keep away from children") and “Đọc kỹ hướng dẫn sử dụng trước khi dùng” ("Read instructions carefully before use");

- For prescription drugs:

+ On the label of the secondary package: On the upper left corner of the drug name must have the symbol "Rx" and the text “Thuốc kê đơn" (“Prescription drugs”);

+ On the package insert: On the upper left corner of the drug name must have the symbol "Rx" and the text “Thuốc này chỉ dùng theo đơn thuốc” (“This drug is taken with prescription only").

- For controlled drugs or other drugs:

+ Radioactive drugs must have the text “THUỐC PHÓNG XẠ” (“RADIOACTIVE DRUG”) written in a bold and uppercase type;

+ Drugs on the list of toxic drugs announced by the Ministry of Health must have the text “THUỐC ĐỘC” (“TOXIC DRUG”) written in a bold and uppercase type;

+ Drugs used to serve a health program of the State must have the text “Thuốc chương trình, không được bán” (“For a health program, not for sale”);

+ Drugs used as emergency aid or humanitarian aid must have the text “Thuốc viện trợ, không được bán” (“As emergency aid or humanitarian aid, not for sale”);

+ The label of drugs used for clinical testing purpose must have the text “Thuốc dùng cho thử lâm sàng. Cấm dùng cho mục đích khác” (“Do not use for any purposes other than the clinical testing”).

In addition to the above-mentioned precautions and recommendations, other precautions and recommendations for each type of drug are as follows:

- The administration route of injectable drug must be written briefly or in full on the label, including: "tiêm bắp" ("intramuscular injection"), "tiêm dưới da" ("subcutaneous injection"), "tiêm tĩnh mạch" ("intravenous injection"), "tiêm truyền tĩnh mạch" ("intravenous infusion"), etc.

- The text “Thuốc nhỏ mắt” and “Thuốc tra mắt” shall be written on labels of eye drops and eye ointment respectively; “Thuốc nhỏ mũi” on labels of nose drops; “Thuốc nhỏ tai” on labels of ear drops;

- The text “Thuốc dùng ngoài” shall be written on labels of topical drugs; “Không được tiêm” ("No injection") on bottles of oral drugs;

- Drugs that must be shaken well before use (E.g.: multi-dose packages of drugs in the form of blends, powder and granule that must be reconstituted before use or easily deposited or separated into layers after being dissolved) must have the text “Lắc kỹ trước khi dùng” ("Shake well before use").

More provisions can be found in Circular No. 01/2018/TT-BYT of the Ministry of Health of Vietnam, which takes effect from June 01, 2018.

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