Circular No. 12/2002/TT-BYT guiding the advertisement of vaccines and immunological products for human use

CIRCULAR

Guidelines for advertising vaccines and human immunological products

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Pursuant to Decree No. 59/2002/ND-CP dated June 4, 2002 of the Government on abolishing certain licenses and replacing some licenses with other management methods, and based on Decision No. 2557/2002/QD-BYT dated July 4, 2002 of the Minister of Health on issuing regulations on information and advertising of medicines for humans and cosmetics directly affecting human health, the Ministry of Health provides guidelines for advertising vaccines and human immunological products as follows:

I. GENERAL PROVISIONS

1. Vaccines and immunological products are special goods that directly affect the health and lives of users. Therefore, advertising of vaccines and immunological products must help healthcare staff and the public gain accurate knowledge about their nature, effects, and safe and reasonable usage. therefore, advertising for vaccines and biological products must assist healthcare staff and the public to have accurate knowledge about the nature, effects, and safe and reasonable use of vaccines and biological products.

2. Scope of application and subjects regulated:

2.1. Scope of Regulation:

2.1. Scope of regulation:

Regulations on advertising vaccines and immunological products that have been granted registration certificates for circulation in Vietnam by the Ministry of Health and are still valid.

a. Organizations and individuals with the function of trading in vaccines and biological products domestically or units authorized to participate in vaccine and biological product advertising activities as prescribed in this Circular

2.2. Subjects regulated:

3. a. Organizations and individuals engaged in domestic trade of vaccines and immunological products or units authorized to participate in vaccine and immunological product advertising activities as stipulated in this Circular.

4. b. Organizations and individuals engaged in foreign trade of vaccines and immunological products that have been granted operating licenses in the field of vaccines and immunological products in Vietnam by the Ministry of Health.

The content of advertising vaccines and immunological products must ensure objectivity, accuracy, truthfulness, scientific validity, clarity, and compliance with registered advertising content.

Organizations and individuals advertising vaccines and immunological products must be responsible for the information provided and their advertising activities.

II. ADVERTISING VACCINES AND IMMUNOLOGICAL PRODUCTS FOR HEALTHCARE STAFF

1. Forms of advertising vaccines and immunological products for healthcare staff:

1.1. Distribution of promotional materials for vaccines and immunological products.

1.2. Seminars introducing vaccines and immunological products.

1.3. Exhibitions and introductions of vaccines and immunological products at conferences and seminars for healthcare staff.

2. Content used for advertising vaccines and immunological products must be consistent with the following documents:

2.1. The user guide included in the application dossier for the registration certificate for circulation of vaccines and immunological products.

2.2. Research reports, articles about vaccines and immunological products published in officially recognized international documents.

3. Advertising content for vaccines and immunological products for healthcare staff must include the following information:

3.1. Name of the vaccine and immunological product: brand name and generic name.

3.2. Composition.

3.3. Finished product form, dosage, and packaging method.

3.4. Indications.

3.5. Contraindications and precautions.

3.6. Usage method, dosage, and route of administration.

3.7. Side effects and adverse reactions, preventive measures.

3.8. Interactions with other vaccines and immunological products.

3.9. Storage conditions.

3.10. Name and address of the manufacturer and distributor of vaccines and immunological products.

3.11. List of reference materials.

4. Distribution of promotional materials for vaccines and immunological products for healthcare staff:

4.1. Promotional materials for vaccines and immunological products for healthcare staff must be prepared according to the provisions of Section 3, Part II of this Circular.

4.2. Parts of the material providing evidence and citations illustrating the advertising content taken from journals, reports, etc., must be truthful, up-to-date, and clearly state the name of the document, author, and publication date.

4.3. Promotional materials for vaccines and immunological products must bear the phrase: "Material for healthcare staff."

4.4. Promotional materials for vaccines and immunological products are only valid for one year from the date of printing and distribution. After one year, if a unit wishes to continue advertising, they must re-register the application dossier.

5. Seminars advertising vaccines and immunological products for healthcare staff:

5.1. Each product advertised in a seminar must include the contents specified in Section 3, Part II of this Circular, plus a summary of the production process and quality control of the vaccine and immunological product.

5.2. Reporters at the seminar must be experienced professionals who have used the vaccine and immunological product extensively.

5.3. Foreign organizations and individuals wishing to hold seminars to introduce vaccines and immunological products in Vietnam must cooperate with a Vietnamese healthcare organization such as hospitals, specialized medical institutes, the National Institute of Hygiene and Epidemiology, Pasteur Institute Nha Trang, Pasteur Institute Ho Chi Minh City, Western Highlands Hygiene and Epidemiology Institute, and professional associations.

6. Exhibitions and introductions of vaccines and immunological products at conferences and seminars for healthcare staff:

6.1. All exhibition and advertising activities of units at conferences and seminars must comply with this Circular's regulations and other relevant laws.

6.2. The organizing and hosting units of the conference and seminar and the units exhibiting and advertising vaccines and immunological products at the conference and seminar must be responsible for their activities.

III. ADVERTISING VACCINES AND IMMUNOLOGICAL PRODUCTS FOR THE PUBLIC

1. Forms of advertising vaccines and immunological products for the public:

a. In books, newspapers, magazines, leaflets.

b. On television and radio.

2. c. Through fairs and exhibitions.

d. On other mass media.

The content of advertising vaccines and immunological products for the public must be concise, easily understandable, appropriate for the general public's level of understanding, and must include the following information:

2.1. Name of the vaccine and immunological product: brand name and generic name.

2.2. Indications.

2.3. Usage method, dosage, and route of administration.

2.4. Contraindications and precautions.

2.5. Side effects and precautions when using.

2.6. Name and address of the manufacturing and distributing entity.

3. 2.7. Warning: "Use under the guidance of healthcare staff.", When advertising vaccines and immunological products for the public on television and radio, the contents of items 2.1, 2.2, 2.4, 2.5, and 2.7 must be read out loud and clearly.

In the content of advertising vaccines and immunological products for the public, no wording or images, sounds that threaten or create the following impressions may be used:

3.1. This vaccine and immunological product is the best.

3.2. This vaccine and immunological product has very high efficacy.

3.4. This vaccine, biological product may be used without the guidance of healthcare staff.

IV. PROCEDURES FOR RECEIVING APPLICATIONS FOR VACCINE AND BIOLOGICAL PRODUCT ADVERTISEMENTS

1. Organizations and individuals wishing to advertise vaccines and biological products for healthcare staff and the public must submit advertising registration applications to the Ministry of Health (Preventive Medicine Department).

2. The advertising registration application includes the following documents:

a. Advertising registration form (attached model)

b. Advertising content. If it is a seminar, the program of the seminar, the materials intended to be displayed and distributed at the seminar, the content of the reports, the name and scientific title of each speaker must be provided. For television and radio advertisements, a draft script must be submitted with a clear description of the visual and audio components.

c. Verification documents for the advertising content.

d. Registration certificate for circulation of the advertised vaccine and biological product issued by the Ministry of Health.

e. In cases where an entity is authorized to advertise another entity's vaccine or biological product, in addition to the aforementioned documents, a power of attorney from the entity owning the registration certificate for the advertised vaccine or biological product must also be included.

3. All documents in the application file must bear the stamp of the entity preparing the application file.

4. Within fifteen working days from the date of receipt of a valid application, if the Ministry of Health does not issue a document requesting modifications or supplements, the entity will have the right to advertise according to the registered content.

In case the Ministry of Health issues a document requesting modifications or supplements, the entity registering the advertisement must modify or supplement the advertising content and send the modified content to the Ministry of Health. Within five working days from the date of receipt of the modified advertising content, if the Ministry of Health does not issue a document requesting modifications or supplements, the entity will have the right to advertise according to the modified content.

In cases where the entity makes modifications or supplements but does not comply with the requirements stated in the Ministry of Health's document, the Ministry of Health will notify the entity registering the advertisement in writing to make appropriate modifications or supplements.

The date of receipt of the advertising registration application and the date of receipt of the modified application are recorded in the Preventive Medicine Department's incoming correspondence book of the Ministry of Health.

5. Advertising materials for vaccines and biological products become invalid in the following cases:

5.1. The registration certificate for circulation of the vaccine or biological product has expired.

5.2. The vaccine or biological product has been withdrawn from circulation or has been advised against use by the competent authority.

5.3. There are changes in the advertising content.

V. VIOLATION HANDLING

Organizations and individuals violating the provisions of this Circular shall be subject to legal sanctions depending on the severity of the violation.

VI. IMPLEMENTATION PROVISIONS

1. This Circular takes effect from the date of signature and issuance.

2. Organizations and individuals participating in vaccine and biological product advertising activities within the territory of Vietnam are responsible for implementing this Circular.

3. The Preventive Medicine Department, the Inspectorate of the Ministry of Health, and the Health Departments of provinces and centrally-administered cities are responsible for guiding, organizing inspections, and supervising the implementation of this Circular.

ADVERTISING REGISTRATION FORM

Respectfully submitted to: Preventive Medicine Department - Ministry of Health

1. Name of the entity registering the advertisement:

2. Address:

3. Telephone number, Fax:

4. Name and telephone number of the person or department responsible for registering the application:

5. Business License Number:

6. List of vaccines and biological products being registered for advertisement:

7. Attached documents (as required by the advertising registration application procedures stipulated in Section IV.2)

- Proposed advertising content

- Verification documents for advertising content

- Copy of business license

- Copy of registration certificate for circulation of the vaccine, biological product

- Power of attorney from the entity owning the registration certificate for circulation of the vaccine, biological product (if authorized)

8. Commitment of the entity registering the vaccine and biological product advertisement: We have carefully studied Circular No.: …/2002/TT-BYT dated … issued by the Minister of Health regarding the guidelines for advertising vaccines and immunological products for human use and commit to complying with the provisions of the Circular.