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IMPORTED HEALTH SUPPLEMENTS REGISTRATION PROCEDURE

Functional foods are foods that offer health benefits beyond their nutritional value. In Vietnam, in order to manufacture or sell functional foods, the manufacturer must comply with all conditions and requirements stated in the law. That could be fulfilled by imported functional food/ health supplements registration procedure. 

I. Legal basis

- Law on Food Safety;

- Decree 15/2018/NĐ-CP on the elaboration of some articles of the law of food safety;

- Circular 18/2019/TTBYT guidelines on good manufacturing practices (GMP) for health supplements.

Food suppliers must register the declarations of the following products:

Dietary supplements (health supplements) medical foods, food for special dietary uses.

II. An application for regulations of the declaration of imported health supplements consists of:

a) The declaration form;

b) 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 the safety of users or permits the free sale of the products in the country of origin/exporting country (the certificate must be consular legalized);

c) Original copy or certified true copy of the food safety data sheet issued within 12 months before the self-declaration is made by a designated laboratory or a laboratory complying with ISO17025; the datasheet 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);

d) Documents about scientific evidence of the effects of the product or ingredients (original or authenticated copy). If scientific evidence of the 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;

dd) The certificate of Good Manufacturing Practice (GMP) or an equivalent certificate if the imports are dietary supplements, applicable from July 01, 2019 (a copy authenticated by the supplier).

III. Conditions of imported health supplements/functional foods

Imported health supplements shall be manufactured by a manufacturer that has been granted one of the following certificates by a competent authority of the manufacturing country (including food safety regulator or organization designated or acknowledged by the food safety regulator or another country’s organization acknowledged by the regulatory authority of the manufacturing country):

a) Certificate of GMP compliance if it is a manufacturer of health supplements;

b)  Certificate of compliance with GMP for herbal medicinal products and traditional medicinal products whose dosage forms are equivalent to those of imported health supplements if it is a:

- Manufacturer of countries included by the Ministry of Health in the list of countries that have signed a mutual recognition agreement on GMP inspections with Vietnam;

Manufacturers of ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) countries or Australia, which has undergone GMP compliance inspection by one of the SRAs of the U.S (US Food and Drug Administration - USFDA), EU countries (European Medicines Agency - EMA), Australia (Therapeutic Goods Administration - TGA), Japan (Pharmaceuticals and Medical Devices Agency - PMDA) or Canada (Health Canada);

- For countries that do not issue GMP, it is required to confirm manufacturers’ compliance with requirements and conditions for the manufacturing of health supplements or herbal medicinal products and traditional medicinal products in writing or publish the compliance on the official website of the competent authority of such countries or territories.

IV. An application for regulations of the declaration of domestic functional foods consists of

a) The declaration form (Form No. 02 in Appendix I hereof);

b) Original copy or certified true copy of the food safety data sheet issued within 12 months before the self-declaration is made by a designated laboratory or a laboratory complying with ISO 17025; the datasheet 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);

c) Scientific evidence of the effects of the product or ingredients (original or authenticated copy). If scientific evidence of the 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;

d) The certificate of food safety if one is required (a copy authenticated by the supplier);

dd) The certificate of Good Manufacturing Practice (GMP) if the domestic products are dietary supplements, applicable from July 01, 2019 (a copy authenticated by the supplier).

3. The documents must be written in the Vietnamese language; documents in other languages must be translated into the Vietnamese language and notarized. The documents must be unexpired when the application is submitted.

 

If the Client needs further assistance, please contact Doanh Tri Law Firm directly via:

Hotline: (+84) 911.233.955 

Email: luatdoanhtri@gmail.com

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