The amended Law on Pharmacy in 2024 was approved on November 21, 2024 and takes effect from July 1, 2025, together with the Government's Decree 163/2025/ND-CP dated June 29, 2025 guiding the implementation of the Law on Pharmacy, which has introduced new regulations on drug advertising. In this article, we will clarify these new points and propose some compliance recommendations for pharmaceutical enterprises in drug advertising activities.
1. New points in regulations on drug advertising
Decree 163/2025/ND-CP, effective from July 1, 2025, completely replaces the previous provisions in Decree 54/2017/ND-CP and 155/2018/ND-CP (Decree 163). However, the basic principles remain the same, such as that only over-the-counter drugs are allowed to be advertised to the public and advertising content must be approved by the Ministry of Health in advance. However, Decree 163/2025/ND-CP adds more detailed regulations to prevent false advertising, exaggeration of drug use, or misleading about the effectiveness of treatment. This reflects the State's efforts to protect public health through stricter management of drug advertising activities.
1.1. Expanding the list of prohibited content
One of the key novelties is the clarified and expanded list of prohibited phrases and content in drug ads. Clause 6, Article 104 of Decree 163 specifically lists words such as "root treatment", "specialization", "eradication", "top-notch", "100% guarantee", "safety", "completely cured", "not worried", "recommended", "hotline" and similar phrases are strictly prohibited. Compared to Decree 54/2017/ND-CP, phrases such as "definitive" or "100% cured" are now emphasized as not allowed to be used, in order to avoid excessive statements that can lead consumers to use drugs in the wrong way.
1.2. More flexibility in the implementation of administrative procedures
The new decree also improves administrative procedures related to drug advertising. Enterprises still have to apply for a Certificate of Advertising Content from the Ministry of Health before making an advertisement, but can now adjust the Certificate in cases of changes in administrative information (such as business name, address) or minor changes in labels, packaging, etc without submitting a new application. In addition, if the certificate has errors due to the licensing agency, the enterprise has the right to request correction. These changes help reduce the burden of administrative procedures, creating more favorable conditions for businesses.
1.3. Strengthening technical requirements
Decree 163 adds detailed technical requirements when advertising in the media. Video or audio ads must ensure that the scenes are presented continuously, pause long enough for the viewer to read through the information, and must not insert multiple drugs in the same ad. Mandatory information such as drug names, ingredients, indications, and recommendations must be presented clearly and easily understood. These regulations are concretized compared to the past, ensuring that consumers receive accurate information and are not confused by complicated presentations.
1.4. New management measures have a strong deterrent effect
A notable new point is the measure to suspend the receipt of advertising records for violating establishments, such as unauthorized advertising or wrong approved content. The suspension period can last from 6 months to 1 year, depending on the severity of the violation. This is a strong form of sanction, aiming to prevent recidivism and encourage businesses to strictly comply with legal regulations in pharmaceutical advertising, a product that directly affects the health of consumers.
2. Conditions and scope of permitted drug advertising
2.1. Over-the-counter medications
According to the amended Pharmacy Law 2024, only over-the-counter drugs, which fall under the list issued by the Ministry of Health, are allowed to be advertised to the public. Prescription drugs such as antibiotics and special drugs are prohibited from being advertised in any form, except for providing scientific information to health workers. This regulation continues to be maintained from the Law on Pharmacy 2016, in order to ensure the safety of drug users.
2.2. Drugs not subject to restricted use
Advertised drugs must not be on the list of recommended restricted use or must be used under the supervision of a physician. This includes over-the-counter medications that have special safety warnings, such as medicines containing active ingredients that require caution. This regulation aims to avoid the risk of consumers using drugs without the guidance of a medical professional.
2.3. Drugs with valid circulation registration numbers
Drugs must have a valid circulation registration certificate in Vietnam. If the drug expires, is revoked or the registration number is withdrawn, all advertising activities must be stopped immediately. Businesses need to closely monitor the legal status of drugs to ensure regulatory compliance.
3. Dossiers and procedures for applying for drug advertising
3.1. Appraisal agencies
The Ministry of Health, specifically the Drug Administration of Vietnam, is responsible for receiving and appraising dossiers of request for certification of drug advertisement content. Businesses can apply in person, by post, or online. This process has not changed from before, but Decree 163 has added flexible mechanisms to reduce administrative burdens.
3.2. Subjects submitting dossiers
Normally, the drug registration unit (registration number holder) will submit the dossier in his name. However, the new Decree allows authorizing other distributors or supporting units such as law firms and advertising companies to carry out advertisements, as long as there is a valid power of attorney and the authorized unit meets the conditions for pharmacy business.
3.3. Components of the dossier
Depending on the type of advertisement, the dossier of application for certification of drug advertising content will include different components of the dossier. In general, the dossier will include the following basic components:
- Application: According to the prescribed form.
- Advertising creative templates: Designs, scripts, or audio/video recording files.
- Supporting documents: A copy of the drug registration certificate, the Certificate of eligibility for pharmacy business, and the power of attorney (if any).
- Related documents: Medication labels, approved instruction sheets, or seminar agendas if advertising through the event.
3.4. Appraisal process
The Ministry of Health will appraise the dossier within 15 days from the receipt of a complete and valid dossier. If the dossier needs to be supplemented, the enterprise will receive a notice to complete. The advertisement content certificate does not state the expiration date, but it will expire if the drug expires, is recalled, or there is a recommendation to restrict use.
4. Content requirements and limitations in drug advertising
4.1. Required information
Drug advertisements must be consistent with approved drug labels and instruction sheets, including:
- Name of the drug, ingredients (active ingredients/medicinal materials), indications, administration, dosage.
- Contraindications, special recommendations (pregnant women, children, etc.).
- Caution, side effects, harmful reactions.
- Name and address of the manufacturer or registrar of the drug.
- The recommended sentence "Read the instructions for use carefully before use" and the number of the Advertising Content Certificate.
4.2. Presentation requirements
- On television/radio: Read the required information clearly, if there are 3 or more active ingredients, you can read the name of the active ingredient group.
- On electronic newspapers/social networks: Display full information such as user manuals.
- Video ads: Scenes must pause long enough for viewers to read all the information.
- Outdoor advertising: Includes minimal information such as drug name, manufacturer, and recommendation.
The advertising language must be in Vietnamese, the font size must be easy to read (not less than 12pt on A4 size), and do not use words that violate fine customs and customs.
4.3. Some prohibited contents worth noting
- False advertising: Misleading about the ingredients, effects, or origin of the drug is prohibited.
- Absolute words: Phrases such as "best", "root cure", "cured immediately" are prohibited.
- Prohibition of indications of dangerous diseases: Do not advertise drugs for diseases such as cancer, tuberculosis, diabetes, etc.
- Unrecognized research results: Do not use data that has not been approved by the Ministry of Health.
- Taking advantage of reputation: It is forbidden to use images of doctors, medical staff, or thank you letters for advertising.
- Prohibited images: Do not use medical symbols, images of rare animals, or inappropriate images of patients.
- Word-of-mouth recommendations: Prohibit phrases like "everyone in my family uses it" to encourage the use of drugs.
5. Sanctions for violations in drug advertising
Violations of regulations on drug advertising can lead to severe sanctions:
- Fines: Advertising prescription drugs or expired drugs can be fined from 50-70 million VND (individuals) or 100-140 million VND (organizations). Advertising without permission or wrong content is fined from 30-40 million VND.
- Remediation: Businesses must remove infringing advertisements and correct false information.
- Temporary suspension of receipt of dossiers: Enterprises with serious violations may be prohibited from submitting new advertising dossiers for 6-12 months.
- Criminal handling: In serious cases, individuals may be prosecuted for criminal liability for the crime of false advertising.
The new regulations in the amended Law on Pharmacy in 2024 and Decree 163/2025/ND-CP demonstrate the State's determination to strictly manage drug advertising, protect consumers from false information, and create more favorable conditions for businesses to comply with the law. Pharmaceutical enterprises need to understand the conditions, procedures, and limitations of advertising content, and monitor the legal status of drugs to avoid violations. Strict compliance not only helps to avoid heavy sanctions but also contributes to building consumer trust, ensuring the safe and effective use of drugs in the community.
