Some notes to consider when advertising drug in Vietnam
I am currently working at an advertising company, and some of my clients are pharmaceutical companies. I would like to learn about the regulations regarding drug advertising. Thank you!
Ha Nam - Tien Giang
Some notes to consider when advertising drug in Vietnam - image from internet
Legal basis: Articles 125 and 126 of the Decree 54/2017/ND-CP
1. The drug advertisement contents shall comply with the following documents:
- The label and package insert approved by the Ministry of Health;
- The treatise on the drug in the National Pharmacopoeia of Vietnam;
- Related instructions provided or recognized by the Ministry of Health.
2. The drug advertisement contents have the following compulsory information:
- Drug name;
- Active ingredients or herbal materials in the approved package insert. Names of herbal materials must be written in Vietnamese language. Names of untranslatable foreign herbal materials may be written in Latin language;
- Indications;
- Uses;
- Dosage;
- Contraindications and warnings for special users (pregnant women, breast-feeding women, children, old people, people having chronic diseases);
- Cautions and what to avoid when using the drug;
- Side effects and adverse effects;
- Name and address of the manufacturer;
- The text “Đọc kỹ hướng dẫn sử dụng trước khi dùng" (“Read the instructions carefully before use”);
- The text “Số Giấy xác nhận nội dung quảng cáo thuốc của Bộ Y tế: .../XNQC..., ngày ... tháng ... năm...;” (“Number and date of the certification of drug advertisement contents issued by the Ministry of Health: …”) at the end of the first page;
- Pages of a multi-page document must be numbered. The first page must specify the number of pages and contain the table of content;
- Reference documents and extracts therefrom are specified. The extracts must be accurate without addition or removal of information which leads to misunderstanding of the safety and efficacy of the drug.
3. The contents of an audio or video advertisement must contains following information:
- Drug name;
- Active ingredients or herbal materials in the approved package insert. Names of herbal materials must be written in Vietnamese language. Names of untranslatable foreign herbal materials may be written in Latin language;
- Indications;
- Contraindications and warnings for special users (pregnant women, breast-feeding women, children, old people, people having chronic diseases);
- Name and address of the manufacturer;
- The text “Đọc kỹ hướng dẫn sử dụng trước khi dùng" (“Read the instructions carefully before use”);
If the drug consists of 03 or more active ingredients, each of them or the groups of vitamins, minerals and herbal materials must be read aloud.
4. Contents of advertisements on online newspapers, websites, electronic devices, advertising screens and other means of advertising defined by advertising laws:
- The contents of an advertisement that has sounds shall comply with regulations same as contents of an audio or video advertisement;
- The contents of an advertisement without sounds shall contain sufficient information as prescribed by law.
- If the advertisement is an audio or video track that has multiple pages or footages, the pages or footages must be continuous and stay still for viewers to read all information; the page or footage that contains product information must be still for viewers to read such information. The script must specify how the pages of a multi-page advertisement are shown.
- Such an advertisement must not advertise more than one drugs to avoid confusion.
5. The contents of an outdoor advertisement shall be shown on one side of the board and contains the follwoing information:
- Drug name;
- Active ingredients or herbal materials in the approved package insert. Names of herbal materials must be written in Vietnamese language. Names of untranslatable foreign herbal materials may be written in Latin language;
- Name and address of the manufacturer;
- The text “Đọc kỹ hướng dẫn sử dụng trước khi dùng" (“Read the instructions carefully before use”);
- The text “Số Giấy xác nhận nội dung quảng cáo thuốc của Bộ Y tế: .../XNQC..., ngày ... tháng ... năm...;” (“Number and date of the certification of drug advertisement contents issued by the Ministry of Health: …”) at the end of the first page;
If the advertisement contains information about the effects and indications of the drug, sufficient information must be provided.
6. Voice and text in a drug advertisement shall comply with the Law on Advertising.
7. Minimum font size: 12; Font: VnTime or Times New Roman; Page: A4.
8. The script must clearly describe the graphics, dialogues, text and music.
9. A drug advertisement may only provide information about the drug and may not provide information not related to the drug.
10. Information and images banned from drug advertisements
- Information and images prescribed in the Law on Advertising.
- Information that causes misunderstanding about the ingredients, effects, indications or origin of the drug.
- Information causing the viewers to believe that the drug is the best, the drug can be used without physician’s counsel, the drug is completely harmful, the drug has no contraindications or adverse effects.
- Words or images that exaggerate the effects of the drug.
- Information that equates effects of some ingredient of the drug with effects of the drug.
- The following words and phrases: “điều trị tận gốc”, “tiệt trừ”, “chuyên trị” (“complete treatment"), “hàng đầu”, “đầu bảng”, “đầu tay” (“best”, “top”), “lựa chọn”, “chất lượng cao” (“high-quality”), “đảm bảo 100%” (“100% guarantee”), “an toàn” (“safe”), “dứt”, “cắt đứt”, “chặn đứng” (“stop”, “end”), “giảm ngay”, “giảm liền”, “giảm tức thì” (“relieve instantly”), “khỏi ngay”, “khỏi hẳn” (“treat instantly”), “yên tâm”, “không lo”, “khỏi lo” (”no worries”), “khuyên dùng” (“recommended”), “hotline”, “điện thoại tư vấn” (“hotline”).
- The following indications:
+ Treatment of tuberculosis or leprosy;
+ Treatment of sexually transmitted diseases;
+ Treatment of insomnia;
+ Aphrodisiac indications;
+ Treatment of cancers or tumors;
+ Drug detoxification;
+ Treatment of diabetes mellitus or similar metabolic disorders;
+ Treatment of viral hepatitis or new dangerous diseases.
- Drug or medicinal material quality test results.
- Pre-clinical study results.
- Clinical study results or bioequivalence study results that have not been recognized by the Ministry of Health.
- Names, positions, letters of other organizations or individuals used for advertising purposes.
- Origin of the drug or medicinal material used for advertising purposes.
- Image, name or symbol of a health worker.
- Images of an animal or plant on the list of priority protected endangered, precious and rare species.
- Words that are expressed as advice or tips that recommend the drug.
- Images of patients used for description of symptoms or effects of the drug that are not conformable with relevant documents and instructions provided or recognized by the Ministry of Health.
Best regards!
