PROCEDURE ON IMPORTED FUNCTIONAL FOODS ANNOUCEMENT

As well as domestically produced functional food products, imported functional food products will also have to register for the product declaration. In the article below, Lincon Law Firm will give preliminary advice on the record as well as the procedure to announce this type of functional food product. 

1. Application for registration of imported functional foods declaration:

Product proclamation dossier must be valid at the time of submission, presented in Vietnamese and if there is a document in a foreign language. It must be translated into Vietnamese and notarized. The dossiers include the following documents: 

– The declaration form;

– The Certificate of Free Sale, Certificate of Exportation or Health Certificate issued by a competent authority of the country of origin/exporting country, which assures safety of users or permit free sale of the products in the country of origin/exporting country (the certificate must be consularly legalized);

– Original copy or certified true copy of the food safety data sheet issued within 12 months before the self-declaration is made by an designated laboratory or a laboratory complying with ISO 17025; the data sheet must specify safety indicators prescribed by the Ministry of Health according to risk management principles under international regulations (or standards applied by the supplier if relevant regulations of the Ministry of Health are not available);

– Documents about scientific evidence of the effects of the product or ingredients (original or authenticated copy). If scientific evidence of effects of the ingredients is used, the daily dose must be greater or equal to 15% of the content of such ingredients mentioned in the document;

– The certificate of Good Manufacturing Practice (GMP):

In order to be granted a GMP Certificate, an enterprise must submit a set of documents to the Ministry of Health, including the following documents:

– The application form;

– A floor plan of the production area and production lines (certified by the applicant);

– A list of primary equipment at the facility.

After submitting a valid dossier, within 15 days from the date of submission, the Ministry of Health will set up an appraisal team and conduct a physical assessment at the facility and make an appraisal record.

If the appraisal results are satisfactory, the enterprise will be granted the GMP Certificate within 30 working days from the date of submitting a complete and valid application.

If the inspection result is not satisfactory, explanation shall be provided in the inspection record. After rectification, the applicant shall send a notice to the inspectorate. Within 07 working days from the receipt of such notice, the inspectorate shall consider and request the Ministry of Health to issue the certificate of GMP for dietary supplements. If rectification is not done within 03 months from the end of the inspection or a notice of rectification is not sent to the inspectorate, the application shall be rejected.

2. Procedures for registration of imported functional foods declaration

Procedures for registration of imported functional foods declaration is quite similar to the procedures for registration of domestic functional foods declaration, in detail:

– Step 1: Enterprises will submit documents to competent authorities;

– Step 2: Within 07 working days (for medical foods, food for special dietary uses) or 21 working days (for dietary supplements) from the day on which adequate documents are received, the receiving authority shall verify the application and issue a certificate of registered product declaration.

– Step 3: If the application needs to be supplemented, the receiving authority shall provide explanation in writing and specify the legal basis.

+ Within 07 working days from the day on which the supplemented application is received, the receiving authority shall verify it and make a written response.

If the applicant fails to supplement the application within 90 working days from the day on which a written request is made, the application will be invalidated.

+ In case of change to the product name, origin or ingredients, another application shall be submitted. In case of other changes, the applicant shall submit a written notification to the receiving authority.

+ After the dossier is assessed, the receiving authority shall post on its website and update on the food safety database the names and products of suppliers whose product declarations have been registered.

3. The competent authorities:

– The Ministry of Health for declarations of dietary supplements;

– A competent authority designated by the People’s Committee of the province for medical foods and food for special dietary uses;

– In the cases where the declaration includes the products mentioned in the two above cases, the application may be submitted to either receiving authority.

4. The results of procedure

Certificate of registered product declaration