LEGAL FRAMEWORK TO KEEP IN MIND WHEN REGISTERING TO VERIFY DRUG ADVERTISING CONTENT

Advertising plays an important role in the business operations of enterprises, because through advertising activities, enterprises can increase brand awareness, attract customers to shop and use services. However, current laws have certain constraints and limitations for some specific products. Before advertising, enterprises and goods must meet certain conditions according to the law and must have approval and/or confirmation from specialized management agencies. In particular, drugs are one of the specific products and when advertising, enterprises must carry out procedures to confirm advertising content.

Regarding the legal issue of “advertising” in general, advertising activities are regulated by the Law on Advertising 2012 and its implementing guidelines. Depending on the type of goods, businesses need to review the specialized laws in that field to see if they stipulate the conditions and procedures that need to be met. Businesses can approach in one of the following ways:

• Identify the type of goods to be advertised and the means of advertising
• Then, review and compare with the general provisions of the current Advertising Law and the implementing guidance documents to identify and clarify the “basic” responsibilities and conditions that need to be met.
• Next, review and compare with the provisions of specialized laws to identify and clarify whether, in addition to meeting the “basic” responsibilities, the enterprise must meet obligations or carry out procedures with state agencies.

Within the scope of this article, OTIS will focus on analyzing the legal issues that need to be noted when registering for confirmation of drug advertising content from the perspective of applying specialized legal regulations, namely the 2016 Pharmacy Law and its implementing guidelines. However, OTIS still mentions some basic contents and has a close relationship with specialized legal regulations to ensure that the analysis content is complete and intact.

Definition and some important terms

Definition

Advertising is the use of means to introduce to the public products, goods, services with profit-making purposes; products, services without profit-making purposes; organizations, individuals trading in introduced products, goods, services, except for news; social policies; personal information.

Advertising drugs without the content confirmed by a competent state management agency or not in accordance with the confirmed content is one of the prohibited acts. 

Some important terms

a) Advertising products include advertising content and forms expressed through images, sounds, voices, writings, symbols, colors, lights and similar forms. For example, an advertising product is an ABC drug advertising leaflet, in which the content includes the drug name, drug ingredients, dosage, instructions for use, indications, warnings when using the drug; and the form of expressing the content is the design of the drug box, images describing the instructions for use, etc. 

b) The advertising recipient is the person who receives information from the advertising product through the advertising media.

Can all drugs be advertised?

According to Article 79.2 of the Pharmacy Law 2016, drugs can be advertised if they are on the List of Non-Prescription Drugs. In addition, the drug is not subject to restricted use or is used under the supervision of a physician as recommended by a competent state agency and the drug has a valid circulation registration certificate in Vietnam. Therefore, not all drugs can be advertised.

What means can be used to advertise drugs?

According to Article 118 of Decree 54/2017/ND-CP, drugs are advertised to the public on media in accordance with the provisions of the law on advertising. According to Article 17 of the Law on Advertising 2012, advertising means include:

• Journalism;
• Electronic information pages, electronic devices, terminals and other telecommunications devices;
• Printed products, audio and video recordings and other technological devices;
• Billboards, banners, signs, light boxes, specialized advertising screens;
• Means of transport;
• Fairs, seminars, conferences, event organizations, exhibitions, cultural and sports programs;
• Advertising product carriers; advertising objects;
• Other advertising media in accordance with the provisions of law;
• Note that, currently, when submitting a dossier requesting confirmation of drug advertising content to the competent state agency, the registration facility must choose one of the following forms:
  • Advertising on radio and television;
  • Advertising through seminars, conferences, and organizing events;
  • Advertising on other advertising media (not radio and television).

The differences between the above media and how to handle some issues that arise when advertising on radio and television or through seminars and conferences will be mentioned by the author in another analysis. Accordingly, within the scope of this article, the author analyzes advertising on other advertising media (not radio and television).

Identify the entity entitled to be named in the application for confirmation of drug advertising content

Identifying the entity entitled to be named in the application for confirmation of drug advertising content is necessary and important because currently, a large number of drug products and types of drugs circulating in the Vietnamese market are foreign drugs. For foreign drugs, state agencies need to manage and control entities doing business in Vietnam or having a commercial presence in Vietnam. Accordingly, the entities entitled to be named in the application for confirmation of drug advertising content include:

• Drug registration entities in Vietnam.
• Representative offices in Vietnam of the foreign entities that register drugs in Vietnam and are authorized by these entities.
• Vietnamese pharmaceutical business entities authorized by drug registration entities in Vietnam.

Note that the drug registration facility, including in the case of authorizing a representative office or a Vietnamese pharmaceutical business establishment authorized by the drug registration facility in Vietnam to request confirmation of drug advertising content, must be responsible for the drug advertising content.

Determining cases of granting a certificate of confirmation of drug advertising content

According to Article 120.1 of Decree 54/2017/ND-CP, a certificate of confirmation of drug advertising content is granted when:

• The drug advertising content requests a certificate of confirmation for the first time.
• The drug advertising content has been granted a certificate of confirmation but there are changes in the drug registration basis, drug name, ingredients, concentration or content, dosage form, indications, contraindications, dosage, usage, use of the drug on special subjects, information related to warnings and drug safety.

Procedures for requesting confirmation of drug advertising content

Application for issuance of a certificate of confirmation of drug advertising content

• Application for confirmation of drug advertising content according to the prescribed form.
• Application for confirmation of drug advertising content design.
• Current drug label and instruction sheet approved by the Ministry of Health.
• Reference documents related to the drug advertising content requested for confirmation (if any).
• Authorization letter from the drug registration facility for the facility named in the application for confirmation of drug advertising content in case of authorization.
• Drug circulation registration certificate.
• A license to establish a representative office of a foreign company in Vietnam for a foreign facility requesting confirmation of drug advertising content or a Certificate of eligibility for pharmaceutical business for a Vietnamese pharmaceutical business facility requesting confirmation of drug advertising content.

Note:

The Drug Circulation Registration Certificate and the License to Establish a Representative Office or the Certificate of Eligibility for Pharmaceutical Business as stated above, the two documents have been abolished by law, meaning they do not need to be provided. However, in practice, when submitting the application, the establishment whose name is on the registration application should still declare in the Application for Confirmation of Advertising Content and attach these documents. The purpose is to prove that the drug meets the advertising conditions as stated in Section 2 of this article.

The document is printed in A4 size. For large-format outdoor advertising, the drug advertising content can be presented on A3 size paper and the size ratio compared to the actual size can be clearly stated. All documents in the application must have the seal of the establishment requesting confirmation of the drug advertising content. In case the design of the advertising object has a spatial structure, the application must have a description on A3 size paper of the following mandatory contents:

a) Spatial structure;

b) Numbering of the faces, size of each face; 

c) Size ratio of the design sample compared to the real sample.

Procedures for implementation

Agency responsible for processing: Within 15 days from the date of receiving a complete application for confirmation of drug advertising content, the Department of Drug Administration - Ministry of Health shall appraise and issue a certificate of confirmation of drug advertising content.

Fee for appraisal and confirmation of drug advertising content: 1,600,000 VND/01 application.

Important notes on drug advertising content

The contents stated in this section have a great influence on whether the application for confirmation is approved by the state agency or not. In addition, if the advertising content lacks one of the contents, the facility named in the application may be subject to administrative sanctions (please refer to the content in Section 10 of this Article). Therefore, to save time and effort, the facility named in the application should carefully review and ensure that the advertising content fully and accurately meets the requirements prescribed by law. In which:

(i) Requirements for drug advertising content:

The drug advertising content must be consistent with the following documents:

a) Current drug label and instruction sheet approved by the Ministry of Health;

b) Drug monographs listed in the National Pharmacopoeia of Vietnam;

c) Documents and professional instructions related to the drug issued or recognized by the Ministry of Health;

(ii) Required information

a) Drug name;

b) Pharmaceutical ingredients or medicinal herbs listed in the approved drug instructions. For medicinal herbs, the Vietnamese name must be written; if there is no Vietnamese name, the Latin name must be written;

c) Indications;

d) How to use;

e) Dosage;

f) Contraindications, recommendations for special subjects (pregnant women, breastfeeding women, children, the elderly, people with chronic diseases);

g) Precautions and things to avoid and note when using the drug;

h) Side effects and adverse reactions;

i) Name and address of the drug manufacturing facility;

k) Warning "Read the instructions carefully before use";

At the end of the first page of the drug advertisement content, it must clearly state: Number of the Drug Advertisement Content Confirmation Certificate of the Ministry of Health: …/XNQC…, date … month … year….

For advertisements consisting of multiple pages, the pages must be numbered, and the first page must clearly state how many pages this document has, and which page to look for detailed product information.

The drug advertisement content must clearly note the supporting documents and clearly indicate the information quoted in the supporting documents. The citation must ensure accurate communication of information, without inference or cutting of information in a way that causes misunderstanding about the safety and effectiveness of the drug.

(iii) Some other requirements

The voice and writing in the drug advertisement content must comply with the provisions of the Law on Advertising.

The font size in the drug advertisement content must be clear, easy to read, and easy to recognize, but must not be smaller than size 12 of VnTime or Times New Roman font on A4 paper.

Drug advertising content must only provide information about the drug and must not include information unrelated to the drug.

Information and images that are not allowed in drug advertising content

• Information and images specified in the Law on Advertising.
• Content that causes misunderstanding about the ingredients, effects, indications, and origin of the drug.
• Content that creates the following understanding: This drug is number one; this drug is better than all; using this drug is the best solution; using this drug does not require a doctor's opinion; this drug is completely harmless; the drug has no contraindications; the drug has no unwanted effects; the drug has no harmful effects.
• Sentences, words, and images that are overly speculative, leading to misunderstandings about the effects, indications, and effectiveness of the drug or exceeding the approved effects, indications, and effectiveness of the drug.
• Recording the effects of each ingredient in the drug to over-advertise the effects of the drug or confusing the effects of each ingredient with the effects of the drug.
• The words and phrases: “radical treatment”, “eradicate”, “specialize”, “top”, “top of the line”, “first-line”, “choice”, “high quality”, “100% guaranteed”, “safe”, “stop”, “cut off”, “stop”, “immediate reduction”, “immediate reduction”, “immediate reduction”, “immediate cure”, “complete cure”, “rest assured”, “no worries”, “no worries”, “recommended”, “hotline”, “consultation phone” and words and phrases with similar meanings.

Indications that are not allowed to be included in drug advertising content

a) Indications for the treatment of tuberculosis and leprosy;

b) Indications for the treatment of sexually transmitted diseases;

c) Indications for the treatment of insomnia;

d) Indications for aphrodisiac properties;

dd) Indications for the treatment of cancer and tumors;

e) Indications for the treatment of drug addiction withdrawal;

g) Indications for the treatment of diabetes or other similar metabolic disorders;

h) Indications for the treatment of viral hepatitis and emerging dangerous diseases.

i) Results of drug and drug ingredient quality testing.

j) Preclinical research results.

k) Clinical research results or bioequivalence test results that have not been recognized by the Ministry of Health.

h) Using the name, position, reputation, correspondence, or thank-you letters of organizations and individuals to advertise drugs.

l) Taking advantage of the origin of drugs and drug ingredients to advertise drugs.

m) Images, names, and symbols of medical staff.

n) Images of animals and plants on the list of endangered, precious, and rare species prioritized for protection.

k) Sentences and words that are meant to be used as advice or by word of mouth to recommend the use of drugs.

o) Using images of patients to describe medical conditions or the effects of drugs that are inconsistent with documents related to drugs and professional guidelines issued or recognized by the Ministry of Health.

Drug Advertising Content Confirmation Certificate

The Drug Advertising Content Confirmation Certificate does not state the validity period and expires in the following cases:

a) The drug circulation registration certificate expires;

b) The drug's circulation registration certificate is revoked;

c) Changes in information leading to the need to issue a Drug Advertising Content Confirmation Certificate when the drug has a change in the drug registration basis, drug name, ingredients, concentration or content, dosage form, indications, contraindications, dosage, usage, use of the drug on special subjects, information related to warnings and drug safety.

d) There is a recommendation from the state pharmaceutical management agency to restrict use or use under the supervision of medical practitioners;

dd) The drug contains active ingredients or medicinal herbs that have been removed from the List of non-prescription drugs issued by the Minister of Health.

In case the Drug Circulation Registration Certificate is extended in validity, the Drug Advertising Content Confirmation Certificate will be automatically extended in validity equal to the extension period of the Drug Circulation Registration Certificate.

Administrative sanctions

Note:

The content stated in this section is only to cite some violations, not all violations prescribed by law. Therefore, for each violation, it is necessary to study and review current regulations.

The fine level stated in this section is the fine level applied to individuals, for the same administrative violation, the fine level for organizations is 2 times the fine level for individuals.

For any questions or comments, please contact:
OTIS AND PARTNERS LAW FIRM
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