How to express the name of bone glue, herbal ingredients and traditional ingredients in package inserts in Vietnam?
How to express the name of bone glue in package inserts in Vietnam?
Pursuant to Point a, Clause 4, Article 16 of Circular No. 01/2018/TT-BYT stipulating how to express the name of bone glue as follows:
- Name of the bone glue, type and composition of the bone glue, concentrations, contents or weights of herbal ingredients in the bone glue must be specified;
- If the bone glue has a trade name, this trade name and names of herbal ingredients in the bone glue shall be specified in accordance with regulations in Clause 3 Article 16 of Circular No. 01/2018/TT-BYT;
- In case there is no trade name, the word “cao” (“bone glue”) shall be specified right before the name of herbal ingredient (if the bone glue contains the only ingredient) or the phrase “cao hỗn hợp dược liệu” (“bone glue mixture”) shall be specified right before names of herbal ingredients (if the bone glue contains multiple ingredients).
How to express the name of bone glue, herbal ingredients and traditional ingredients in package inserts in Vietnam? (Image from the Internet)
How to express the name of herbal ingredients and traditional ingredients according to the law?
Pursuant to Clause 3, Article 16 of Circular No. 01/2018/TT-BYT stipulating how to write names of herbal ingredients and traditional ingredients as follows:
- Vietnamese name:
+ Names of herbal ingredients and traditional ingredients shall be conventional names in Vietnamese language as specified in the Pharmacopoeia of Vietnam or in the lists of drugs and medicinal ingredients announced by the Minister of Health;
+ If Vietnamese names of herbal ingredients are not available in the Pharmacopoeia of Vietnam or the lists of drugs and medicinal ingredients announced by the Minister of Health, Vietnamese names of these herbal ingredients as specified in the book “Những cây thuốc và vị thuốc Việt Nam" (“Traditional plants and ingredients of Vietnam”) of Mr. Do Tat Loi, or the book “1000 Cây thuốc và động vật làm thuốc" (“1000 medicinal plants and animals”) of the National Institute of Medicinal Materials. In such cases, names of herbal ingredients shall be decided by the Minister of Health according to the counseling of the Advisory Council for drug registration certification affiliated to the Ministry of Health.
+ If the names of imported herbal ingredients cannot be translated into Vietnamese language, the names in the exporting country (or the country of origin) and their scientific names shall be written;
+ If more than one part of the plant is used as herbal ingredients of traditional ingredients, the parts must be specified. Example: Tam sen, Hoa hoe, Kim ngan hoa.
- Scientific names (Latin names):
+ Scientific names of herbal ingredients or traditional ingredients shall be their scientific names in italics in the Pharmacopoeia of Vietnam or in the lists of herbal ingredients and traditional ingredients announced by the Minister of Health;
+ If scientific names of herbal ingredients and traditional ingredients are not available in the Pharmacopoeia of Vietnam or in the Minister of Health’s lists of herbal ingredients and traditional ingredients, their scientific names in foreign pharmacopoeias shall be written.
How to express the name of semi-finished herbal medicines (excluding bone glue)?
Pursuant to Clause 5, Article 16 of Circular No. 01/2018/TT-BYT stipulating expression of name of semi-finished herbal medicines (excluding bone glue) as follows:
- The name of semi-finished herbal medicine and the composition, concentrations, contents or quantities of herbal ingredients contained in the semi-finished herbal medicine must be fully specified;
- Expression of the name of semi-finished herbal medicine:
+ If the semi-finished herbal medicine has a trade name, this trade name shall be written together with the name of every herbal ingredient contained in the semi-finished herbal medicine in accordance with regulations in Clause 3 Article 16 of Circular No. 01/2018/TT-BYT;
+ If there is no trade name, the name of herbal ingredient shall be written according to regulations in Clause 3 of this Article (if the semi-finished herbal medicine contains the one herbal ingredient) or the text “hỗn hợp dược liệu” (“mixture of herbal ingredients”) shall be written (if the semi-finished herbal medicine contains multiple herbal ingredients). The form of the semi-finished herbal medicine (such as powder or granule) must be also written right before the name of herbal ingredient or the text “hỗn hợp dược liệu”.
- Expression of formula of the semi-finished herbal medicine:
+ If the treatise of Vietnam’s pharmacopoeia or a foreign pharmacopoeia recognized by the Ministry of Health provides criteria for quantifying contents of active ingredients or compounds, name of the semi-finished herbal medicine shall be written together with the contents (%) of active ingredients or compounds quantified in each herbal ingredient;
+ If the treatise of Vietnam’s pharmacopoeia or foreign pharmacopoeias recognized by the Ministry of Health does not provide criteria for quantifying contents of active ingredients or compounds, name of the semi-finished herbal medicine must be written together with the weights of corresponding initial herbal ingredients or the ratio of the semi-finished herbal medicine and the initial herbal ingredients (initial herbal ingredients are herbal ingredients qualified for medicinal use).
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