Dossier for declaration of health supplements imported in Vietnam

Dossier for declaration of health supplements imported is the first step for businesses to carry out the procedures for importing dietary supplements to Vietnam.

Our article will present to you the necessary documents to complete a set of dossiers for declaration health supplements imported in Vietnam.

1. Types of dossiers for declaration of health supplements imported in Vietnam

There are two types of dossiers for declaration of health supplements, which are dossiers of announcement of regulation conformity and dossiers of announcement of conformity with food safety regulations, which are specified in Circular 43/2014/TT-BYT as follows:

  • Imported functional foods with technical regulations must be announced and registered with the Ministry of Health (Food Safety Department) before being circulated on the market.
  • Imported functional foods without technical regulations must be announced in accordance with food safety regulations and registered with the Ministry of Health (the Food Safety Authority) before when put on the market.

2. Dossier for announcement of regulation conformity

2.1. Order of regulation conformity announcement:

a) Step 1: Assessment of conformity

Organizations and individuals shall assess the technical-regulation conformity by one of the following two methods:

  • Self-assess conformity according to the content of conformity assessment as prescribed by law and perform product testing at a designated testing laboratory or an accredited independent or accredited testing laboratory;
  • Through a regulation conformity certification organization designated by the Ministry of Health.

b) Step 2: Register the regulation conformity announcement

Organizations and individuals announcing products shall prepare and submit declaration documents according to regulations to the registration-receiving agency.

2.2. Components of the application for declaration of conformity:

2.2.1. The regulation conformity announcement is based on the results of the regulation conformity certification of the designated conformity certification organization (third party), the dossier includes:

A) Dossier of declaration of conformity with food safety regulations

1- The announcement of regulation conformity is specified in Form No. 02 issued together with Decree 38/2012/ND-CP;

2- A detailed product information sheet, specified in Form No. 03a or Form No. 03c issued together with Decree 38/2012/ND-CP (with a third party seal);

3- Certificate of conformity certification of a third party (notarized copy or copy with presentation of the original for comparison);

B) General legal documents

4- Certificate of conformity with standards of HACCP or ISO 22000 or equivalent in case organizations or individuals producing products have a quality management system certified in conformity with HACCP or ISO 22000 or equivalent standards (copy) notarized copy or a copy showing the original for comparison).

Number of dossiers: 02 sets of dossiers for announcement of regulation conformity and 01 set of general legal documents

Processing time: 07 working days

2.2.2. Announcement of regulation conformity is based on self-assessment results of organizations and individuals producing and trading food (first party), the dossier includes:

A) Dossier of declaration of conformity with food safety regulations

1- The announcement of regulation conformity is specified in Form No. 02 issued together with Decree 38/2012/ND-CP;

2- A detailed product information sheet, specified in Form No. 03a or Form No. 03c issued together with Decree 38/2012/ND-CP (with a third party seal);

3- Results of product testing within 12 months (original or notarized copy enclosed with the original for comparison or consular legalization), including the criteria required by the respective technical regulations , of a designated testing laboratory or an accredited independent or accredited testing laboratory;

4- The quality control plan is developed and applied according to the form specified in Form No. 04 issued together with Decree 38/2012/ND-CP (first party certification);

5- Periodic monitoring plan (first party confirmation);

6- Report on conformity assessment (first-party certification);

B) General legal documents

7- Certificate of conformity with standards of HACCP or ISO 22000 or equivalent in case organizations and individuals producing products have a quality management system certified in conformity with HACCP or ISO 22000 or equivalent standards (copy) a notarized copy or a copy showing the original for comparison).

Number of dossiers: 02 sets of dossiers for announcement of regulation conformity and 01 set of general legal documents

Processing time: 07 working days

3. Dossier of declaration of conformity with food safety regulations

Profile components include:

A) Dossier of declaration of conformity with food safety regulations

1- Declaration of conformity with food safety regulations, specified in Form No. 02 issued together with Decree 38/2012/ND-CP;

2- A detailed product information sheet, specified in Form No. 03b promulgated together with Decree 38/2012/ND-CP (with the seal of the organization or individual);

3- A certificate of free sale or a medical certificate or an equivalent certificate issued by a competent state agency of the country of origin which states that the product is safe for consumers’ health. and in accordance with food legislation (original or notarized copy or consular legalization);

4- Results of product testing within 12 months (original or notarized copy enclosed with the original for comparison or consular legalization), including the criteria required by the respective technical regulations , of a designated or accredited independent or accredited testing laboratory;

5- Periodic monitoring plan (certified by the organization or individual);

6- Product labels circulated in the country of origin and sub-labels in Vietnamese (certified by organizations or individuals);

7- Completed product samples for comparison when submitting dossiers;

8- Scientific information and documents proving the effects of each ingredient that make up the announced function (copy certified by the organization or individual).

B) General legal documents

9- Business registration certificate with food business line or certificate of legal entity for organizations or individuals importing food (a copy certified by the organization or individual);

10- Certificate of establishments meeting food safety conditions, for importers subject to the issuance of certificates of establishments meeting food safety conditions as prescribed (a copy certified by the organization, personal);

11- Certificate of conformity with standards of HACCP or ISO 22000 or equivalent in case organizations or individuals producing products have a quality management system certified in accordance with HACCP or ISO 22000 or equivalent standards (copy). a notarized copy or a copy showing the original for comparison).

Number of dossiers: 02 sets of dossiers for announcement of regulation conformity and 01 set of general legal documents

 

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declaration of health supplements