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Conformity declaration dossier as stipulated in Circular no. 28/2012/TT-BKHCN

28/03/2024
Conformity declaration dossier as stipulated in Circular no. 28/2012/TT-BKHCN

For businesses dealing in goods from the category of products that must be declared conformity such as veterinary drugs, veterinary drug ingredients, fertilizers, plant seeds, livestock, etc., the dossier and procedure for conformity declaration are of great interest.

Therefore, by this article, TIN Holdings would like to share with businesses about the conformity declaration. Let’s find out!

Legal Basis

Circular No. 28/2012/TT-BKHCN specifies standard conformity declaration, conformity declaration, and methods of conformity assessment with standards and technical regulations.

Circular No. 02/2017/TT-BKHCN amends and supplements articles of Circular No. 28/2012/TT-BKHCN dated December 12, 2012, by the Minister of Science and Technology regarding standard conformity declaration, conformity declaration, and methods of conformity assessment with standards and technical regulations.

Circular No. 28/2012/TT-BKHCN

Stipulated conformity declaration

The conformity declaration is stipulated in Circular No. 28/2012/TT-BKHCN:

Organizations and individuals prepare a conformity declaration and submit it directly or send it via postal service to the specialized authority, which is the professional body designated, assigned by the Ministry managing the sector or field, and People’s Committee of province or the central city, with the dossier stipulated as follows:

In cases where the conformity declaration is based on the self-assessment report of the organization or individual (first party), the dossier includes:

a) A conformity declaration (as per Form 2. CBHC/HQ stipulated in Annex III of Circular No. 28/2012/TT-BKHCN and additional content regulated in clause 7 Article 1 of this Circular);

b) A self-assessment report includes:

  • Name of the organization, individual; address; telephone, fax;
  • Name of the product, goods;
  • Number of the technical standard;
  • Conclusion that the product, goods comply with the technical standard;
  • Commitment that the product quality complies with the technical standard, applied standards of declaration and full responsibility before the law for the quality of product, goods, and the self-assessment report.
  • Self-assessment report is based on the self-implementation report of the organization, individual, or based on the assessment report of the registered conformity assessment organization.

Model declaration of conformity

In cases where the conformity declaration is based on the certification of a registered certification organization or a designated certification organization (third party), the dossier includes:

a) A conformity declaration (as per Form 2. CBHC/HQ stipulated in Annex III of Circular No. 28/2012/TT-BKHCN and additional content regulated in clause 7 Article 1 of this Circular);

b) A certified true copy of the corresponding technical standard conformity certificate along with the conformity mark sample issued by the registered certification organization or the designated certification organization to the organization, individual.”

For conformity declaration that is incomplete as per the regulations above, within 03 (three) working days from the receipt of the conformity declaration dossier, the specialized authority shall notify in writing the request to supplement the documents as regulated to the organization or individual declaring conformity. After 15 (fifteen) working days from the date the specialized authority sends the written request and the conformity declaration dossier is not supplemented in full as regulated, the specialized authority has the rights to terminate the processing of this dossier.

For conformity declaration that is complete as per the regulations above, within 05 (five) working days from the receipt of the conformity declaration dossier, the specialized authority organizes an inspection on the validity of the conformity declaration:

  • For complete and valid conformity declaration, the specialized authority issues a Notification of Acceptance of the Conformity Declaration to the organization or individual.
  • The Notification of Acceptance of the Conformity Declaration is valid according to the value of the conformity certificate issued by the designated certification organization or is valid for three (03) years from the date the leader of the organization or individual signs to confirm the conformity assessment report (in the case of organizations or individuals self-assessing conformity).
  • For complete but not valid conformity declaration, the specialized authority notifies the organization or individual in writing about the reasons for not accepting the dossier.

This is our advice on the conformity declaration for your reference. If you have any questions, uncertainties, or require further legal support, please contact our online legal advisory service. In the following article, TIN Holdings’ product declaration service will guide businesses on the process of conformity declaration, stay tuned!