Vietnam Drug Advertising and Promotion Rules: A Practical Guide
By Michael Lee, Helen (Trang) Nguyen
Pharmaceutical products are a special category of goods under Vietnamese law, subject to a stricter regulatory regime than ordinary consumer products. Advertising and promotional activities for drugs are primarily governed by the Law on Pharmacy, the Law on Advertising, Decree No. 81, and Decree No. 163, and are administered by the Ministry of Health ("MOH").
Which Products May Be Advertised
Pharmaceutical products may only be advertised to the public if they meet all of the following conditions:
- The product belongs to the list of over-the-counter ("OTC") medicines;
- The product does not fall under cases of restricted use or use under medical supervision as recommended by the competent state authorities; and
- The product holds a valid Marketing Authorisation ("MA") in Vietnam.
Prescription medicines may not be advertised to the general public.
Advertising Certificate Requirement
Before conducting any pharmaceutical advertising, the MA holder, the authorised representative office in Vietnam of a foreign MA holder, or a pharmaceutical business entity authorised by the MA holder (the "Applicant") must obtain a certificate confirming the advertising content from the MOH (the "Certificate").
The Certificate is valid for an indefinite term but is automatically terminated upon: expiry or revocation of the MA; a change in advertising content not qualifying for amendment; a competent authority recommendation to restrict the medicine's use; or removal of the active ingredient from the OTC list. Any material change to advertising content requires a new Certificate, unless the change qualifies only as an amendment (e.g., updates to facility name, address, packaging specifications, or logos).
Permitted Advertising Content
The content of pharmaceutical advertising must be consistent with the medicine's current labels and package inserts approved by the MOH, the Vietnamese National Pharmacopoeia, and relevant MOH professional guidelines. The following information is mandatory in all pharmaceutical advertisements:
- Medicine name, active ingredient(s), and dosage form;
- Indications, dosage, and administration instructions;
- Contraindications and warnings;
- Instructions to read the package insert carefully before use; and
- Advice to consult a doctor or pharmacist.
Prohibited Practices
The law prohibits any advertising for pharmaceutical products without a valid Certificate. In addition, advertising content must not be misleading, exaggerated, or unverified. Specifically, it is prohibited to use claims, images, indications, research results, endorsements, or expressions that may misrepresent a drug's safety, effectiveness, origin, or approved use, as detailed in Article 104 of Decree 163.
Penalties for Non-Compliance
Advertising without a Certificate attracts fines of VND 40 million to VND 50 million. Organisations committing two or more violations within six months may have their pharmaceutical business licence, product registration certificate, or medical examination and treatment licence suspended for one to three months. Violations relating to advertising content attract fines of VND 10 million to VND 80 million, depending on the nature and severity of the breach.
Sales Promotion Rules
Sales promotion activities for pharmaceutical products may be conducted between businesses in the pharmaceutical sector (e.g., agents, pharmaceutical companies, hospitals, and clinics). Direct promotional activities targeting consumers are not permitted for prescription medicines. Permitted promotional methods include: provision of free samples; gifts; price discounts; voucher programmes; customer loyalty programmes; and cultural or entertainment programmes for customers.
Traders must notify the relevant Department of Industry and Trade before implementing promotional programmes involving lucky draws, prize competitions, or customer loyalty schemes — unless the total value of prizes and gifts is below VND 100 million, or the promotion is conducted exclusively via e-commerce platforms.
Upcoming Legislation
The Government is currently reviewing a draft decree that would amend the current promotional framework to permit sales promotional activities for OTC medicines directly to consumers, while maintaining existing restrictions on prescription medicines.