Required Information in Pharmaceutical Advertisements
According to Clause 2, Article 125 of Decree 54/2017/ND-CP, the contents of drug advertisements must include the following mandatory information:
- Name of the drug;
- Active ingredient or herbal ingredient listed in the approved drug instructions. For herbal ingredients, the Vietnamese name must be used; if no Vietnamese name exists, then use the Latin name;
- Indications;
- Method of administration;
- Dosage;
- Contraindications and warnings for special populations (pregnant women, breastfeeding women, children, the elderly, individuals with chronic diseases);
- Precautions and things to avoid, notices when using the drug;
- Side effects and adverse reactions;
- Name and address of the drug manufacturer;
- The instruction "Read the instructions carefully before use";
- At the end of the first page of the drug advertisement, it must clearly state: Ministry of Health's Drug Advertisement Content Confirmation Number: .../XNQC..., dated ... month ... year...;
- For advertisements with multiple pages, pages must be numbered, and the first page must clearly state how many pages the document consists of and where detailed product information can be found;
- The drug advertisement content must clearly annotate the supporting documents and specifically indicate which information is cited in the supporting documents. Citations must accurately convey the information and must not misinterpret or truncate the information in a manner that could mislead regarding the safety and efficacy of the drug.
Additionally, the content of the drug advertisement must be consistent with the following documents:
- The current drug label and instructions as approved by the Ministry of Health;
- The drug monograph recorded in the Vietnam National Pharmacopoeia;
- Documents and professional guidelines related to the drug issued or recognized by the Ministry of Health.
The above constitutes the mandatory information for drug advertisement content.
Sincerely!
