Confirmation of Declaration of Conformity for Tobacco Products

The Confirmation of Declaration of Conformity for Tobacco Products is a mandatory condition for tobacco products to be legally circulated in the Vietnamese market. Correctly performing the declaration procedure not only helps enterprises comply with specialized management regulations but also limits legal risks during business operations. This article provides an overview of the conditions, dossier, and sequence for issuance according to current regulations.

The competent authority issues certificates of conformity for tobacco products.

Based on Article 6 of Circular 17/2023/TT-BYT (amending Circular 49/2015/TT-BYT), the authority competent to grant the Confirmation belongs to the Health Environment Management Agency under the Ministry of Health.

Note: This authority was transferred from the Vietnam Food Administration. Enterprises must submit dossiers to the new unit.

Required Dossier for applying for a certificate of conformity with regulations for tobacco products.

The legal dossier is detailed in Article 6 of Circular 49/2015/TT-BYT, including:

1. Declaration of Conformity: Prepared according to Form No. 05 issued with the Circular.
2. Detailed Product Information: Accompanied by label designs with full mandatory labeling contents (Form No. 02).
3. Test Results: Results within 12 months from a designated or recognized laboratory, covering required indicators (original, certified copy, or consularly legalized copy).
4. Periodic Monitoring Plan: Prepared according to Form No. 03.
5. Legal Document: Enterprise Registration Certificate.

Procedure for issuing a certificate of conformity with regulations for tobacco products.

The procedure follows Clause 2, Article 6 and Article 7 of Circular 49/2015/TT-BYT (amended by Article 6 of Circular 17/2023/TT-BYT):

Step 1: Conformity Assessment The organization/individual conducts product testing at a designated/recognized laboratory and assesses conformity based on the results.

Step 2: Online Registration Prepare the dossier and submit it online via the website of the Health Environment Management Agency (https://vihema.gov.vn) or the Ministry of Health’s Portal.

Step 3: Appraisal and Confirmation Within 15 working days from receiving a complete and valid dossier:

• The Agency appraises the content and grants the Confirmation of Declaration of Conformity (Form No. 07).
• If invalid, a written request for amendment is issued.
• Note: If the enterprise fails to complete the dossier within 60 days of notification, the registration process is automatically canceled.

Long Phan provides consulting services for the procedures to obtain certificates of conformity for tobacco products.

Long Phan Consulting Company provides comprehensive solutions to support enterprises in overcoming technical barriers:

• Consulting & Completion: Reviewing the legality of existing dossiers (test results, labels); drafting the Declaration, Monitoring Plan, and technical explanations.
• Technical Support: Advising on testing indicators; connecting with designated laboratories; supporting translation and consular legalization.
• Representation: submitting dossiers online; monitoring progress; handling requests for amendments/explanations; working directly with the Agency to ensure timely issuance.

Frequently Asked Questions about the issuance of Certificates of Conformity for Tobacco Products

Below are some frequently asked questions regarding the application process for a certificate of conformity for tobacco products. Please refer to them:

What is the validity period of the Confirmation?

• 05 years: For establishments with advanced quality management certificates (HACCP, ISO 22000, or equivalent).
• 03 years: For establishments without such certificates.
• Renewal: Must re-register 06 months before expiration. (Legal Basis: Article 8, Circular 49/2015/TT-BYT).

Are foreign test results accepted?

Yes, if the laboratory is designated/recognized by Vietnam or accredited under ISO/IEC 17025 with mutual recognition. The document must be original, certified, or consularly legalized. (Legal Basis: Point c, Clause 1, Article 6, Circular 49/2015/TT-BYT).

Difference between Receipt of Declaration vs. Confirmation of Conformity?

• Receipt (Form 06): Confirms receipt of a valid dossier (within 07 days).
• Confirmation (Form 07): The final result confirming product compliance after appraisal (within 15 days). (Legal Basis: Clause 2 and 3, Article 7, Circular 49/2015/TT-BYT).

How to submit online?

Register an account on the Health Environment Management Agency system and use a valid digital signature (Token) to authenticate documents. (Legal Basis: Clause 3, Article 6, Circular 17/2023/TT-BYT).

How to implement the monitoring plan?

Create a plan (Form 03) and conduct periodic testing (every 6 months or 1 year). Results must be stored at the enterprise for inspection. (Legal Basis: Point d, Clause 1, Article 6 and Clause 2, Article 12, Circular 49/2015/TT-BYT).

Conclusion

The Confirmation of Declaration of Conformity for Tobacco Products requires deep understanding of specialized laws and testing techniques. Long Phan Consulting Company is ready to accompany clients in perfecting dossiers and working with authorities. Please contact 1900636389 for professional support.