Chemical Advertising Content Certificate: Steps

The Chemical Advertising Content Certificate for chemicals, insecticides, and bactericides in household and medical use is a mandatory administrative procedure. Businesses must obtain this certificate before public dissemination of advertising materials. Compliance with the correct procedure and a complete legal dossier are prerequisites for approval. Long Phan Consulting Company analyzes the current legal regulations for this matter.

Conditions for the Chemical Advertising Content Certificate

The applicant unit must meet specific legal conditions. These conditions ensure the accuracy and truthfulness of advertising information for health-related products.

General conditions for advertising content confirmation (Article 4, Circular 09/2015/TT-BYT):

• Advertising content must comply with advertising laws and not contain prohibited acts (Article 8, Law 16/2012/QH13).
• The language, text, and images must be concise, common, and comply with Article 18 of the Law on Advertising. The smallest font size must be legible under normal conditions, no smaller than the equivalent of Vntime or Times New Roman 12 on A4 paper.

Specific conditions (Article 8, Circular 09/2015/TT-BYT) for chemicals, insecticides, and bactericides:

• Must meet the advertising conditions specified in Point c, Clause 4, Article 20 of the 2012 Law on Advertising.
• Advertising content must adhere to Article 6 of Decree 181/2013/ND-CP.
• The unit must prepare a complete dossier as required by Article 17 of Circular 09/2015/TT-BYT.
• The applicant must be the entity named on the product’s Certificate of Registration for Circulation, or a legal entity authorized in writing by the certificate holder.

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Competent Issuing Authority

Based on Clause 2, Article 12, Circular 09/2015/TT-BYT (supplemented by Clause 2, Article 1, Circular 20/2024/TT-BYT, effective November 28, 2024), the procedure for the Chemical Advertising Content Certificate is handled at the “Provincial Level”.

The direct implementing agency is the Department of Health of provinces and centrally-run cities. Applicants submit dossiers to the Department of Health where their head office is registered.

Procedure for the Chemical Advertising Content Certificate

This procedure involves three main components: dossier preparation, submission method, and state agency processing. Long Phan Consulting Company analyzes the document requirements and implementation steps.

Required Dossier

The dossier components (Article 13 and Article 17, Circular 09/2015/TT-BYT) include:

• An application form for advertising content confirmation (Appendix 01 of the Circular).
• The Business Registration Certificate or Foreign Trader Representative Office License.
• The proposed advertising content:
  • For broadcast (radio, television): 01 recording (disc or soft file) with 03 accompanying scripts detailing content, visuals (for TV), audio, and music.
  • For non-broadcast media: 03 color-printed mock-ups with a soft file of the content.
  • For conferences/events: Must also include the agenda, speaker list (names, scientific titles, professional qualifications), report content, and handout materials. Speakers must have relevant professional qualifications.
• The product label sample or an approved label sample if required by law.
• The Certificate of Registration for Circulation for the chemical, insecticide, or bactericide.

Submission Methods

Clients may choose one of three methods to submit the dossier to the competent Department of Health:

• Direct: Submit a paper dossier at the One-Stop-Shop (Bộ phận Một cửa) of the Department of Health.
• Online: Submit via the provincial/city Online Public Service Portal (if available for Procedure Code 1.002564).
• Postal Service: Send the complete dossier via public postal service.

Processing Steps

The procedure (Article 20, Circular 09/2015/TT-BYT) follows these steps:

• Step 1: Dossier Submission The applicant submits 01 complete dossier set to the Department of Health where the unit is headquartered.
• Step 2: Dossier Review Within 05 working days (from the date of receipt), the Department of Health must issue a written request for amendments if the dossier is invalid. The applicant has a maximum of 90 days to complete the dossier. If not supplemented within 90 days, the application becomes invalid.
• Step 3: Issuance of Certificate Within 10 working days of receiving a valid dossier, the Department of Health issues the Chemical Advertising Content Certificate. In case of refusal, the Department must provide a written response stating the reasons.

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Regulatory Fees

Applicants must pay a fee. According to Section 19.III, Decision 2495/QD/BYT-2025, the fee for assessment and issuance of the Chemical Advertising Content Certificate for chemicals, insecticides, and bactericides is 150,000 VND (One hundred fifty thousand dong) per dossier.

(Note: From January 1, 2027, this fee is regulated to increase to 300,000 VND).

This fee applies equally to all submission methods (Direct, Online, or Postal Service).

Consulting Services

The Chemical Advertising Content Certificate procedure demands absolute legal and technical accuracy. Long Phan Consulting Company provides professional legal support services to optimize this process.

Our services are designed to ensure compliance and efficiency, covering the following key tasks:

• Legal Assessment and Strategy
  • Assess the legal compliance of proposed advertising content (scripts, mock-ups) against the Law on Advertising and health sector regulations.
  • Review and cross-check the advertising content against the approved product registration dossier to identify and resolve inconsistencies.
  • Advise on content and format to ensure absolute compliance with technical requirements and current legal circulars.
• Dossier Preparation and Finalization
  • Draft key legal documents, including the official application form and the Power of Attorney (if Long Phan is authorized).
  • Assist clients in preparing and processing technical documents and references (including required translation and notarization of foreign documents).
  • Finalize, complete, and systemize the entire dossier to ensure maximum validity upon submission.
• Agency Representation and Follow-up
  • Represent the client to submit the dossier to the competent Department of Health (where the business is headquartered).
  • Proactively monitor the dossier processing status; receive and respond accurately and promptly to any official requests for modification or supplementation.
  • Represent the client until the final result is issued and deliver the Chemical Advertising Content Certificate to the client.

Frequently Asked Questions

Below are common questions regarding the Chemical Advertising Content Certificate procedure.

Which entity is authorized to apply for advertising content confirmation for chemicals?

The applicant must be the entity named on the product’s Certificate of Registration for Circulation, or a legal entity authorized in writing by the certificate holder. Legal Basis: Article 8, Circular 09/2015/TT-BYT.

Which state agency is competent to issue the certificate for medical chemical advertising?

Competence belongs to the Department of Health of provinces and centrally-run cities. The unit submits the dossier to the Department of Health where its head office is located. Legal Basis: Clause 2, Article 12, Circular 09/2015/TT-BYT (supplemented by Clause 2, Article 1, Circular 20/2024/TT-BYT).

What are the main documents required in the dossier?

The dossier includes: The application form (Appendix 01), Business Registration Certificate, proposed advertising content (script or mock-up), product label sample, and the Certificate of Registration for Circulation. Legal Basis: Article 13 and Article 17, Circular 09/2015/TT-BYT.

What is the processing timeline for the certificate?

Within 10 working days of receiving a valid dossier, the Department of Health will issue the certificate. If the dossier is invalid, the agency has 05 working days to request amendments. Legal Basis: Article 20, Circular 09/2015/TT-BYT.

What is the state fee for this procedure?

The fee for assessment and issuance of the certificate is 150,000 VND (One hundred fifty thousand dong) per dossier. Legal Basis: Section 19.III, Decision 2495/QD/BYT-2025.

Conclusion

The above is a complete legal analysis of the Chemical Advertising Content Certificate procedure according to Ministry of Health regulations. This dossier and process involve complex technical requirements demanding strict compliance. For specialized support and representation services to complete the procedure quickly, please contact Long Phan Consulting Company via Hotline: 1900636389 for expert guidance.