Tiếng Việt
What is a Health Supplement?
Health supplement refers to products used to supplement the daily diet of humans to maintain, enhance, or improve the functions of the human body to maintain good health and reduce the risk of illness.
Health supplement products typically contain ingredients such as vitamins, minerals, antioxidants, omega-3 fatty acids, probiotics, and other compounds believed to be beneficial to health.
Health supplement products come in various formulations: capsules, caplets, film-coated tablets, sugar-coated tablets, granules, powders, solutions, suspensions, and syrups.
Legal basis for health supplement business
– Decree No. 15/2018/NĐ-CP issued on February 2, 2018: Provides detailed regulations for the implementation of certain provisions of the food safety law.
– Circular No. 43/2014/TT-BYT issued on November 24, 2014: Regulations on the management of functional foods.
– Law No. 55/2010/QH12 issued on June 17, 2010: Food safety law.
– Decree No. 181/2013/NĐ-CP issued on November 14, 2013: Provides detailed regulations for the implementation of certain provisions of the Advertising Law.
– Advertising Law (No. 47/VBHN-VPQH)
– Circular No. 09/2015/TT-BYT issued on May 25, 2015: Regulations on the confirmation of advertising content for products, goods, and services specifically managed by the Ministry of Health.
– Decree No. 155/2018/NĐ-CP issued on November 12, 2018: Amends and supplements certain provisions related to investment and business conditions within the state management scope of the Ministry of Health.
– Decree No. 67/2016/NĐ-CP issued on July 1, 2016: Regulations on the conditions for production and business of food products under the specialized management of the Ministry of Health.
What are the conditions for trading in Health supplements?
1. Possess appropriate business registration certificate for the Health supplement business sector.
2. Health supplements for trading must have a product declaration registration certificate
The dossier for product registration includes:
* For domestic products:
a) Product declaration form.
b) Good Manufacturing Practice (GMP) certificate of compliance for the facility.
c) Product safety testing results (valid for 12 months).
d) Documentation proving the efficacy of the product or its components, which have been publicly disclosed.
e) Dosage table, Recommended Nutrient Intake (RNI) table.
f) Product specifications (SPEC).
g) Product label sample.
*For imported products:
a) Product declaration form.
b) Good Manufacturing Practice (GMP) certificate of compliance for the facility.
c) Product safety testing results (valid for 12 months).
d) Certificate of Free Sale (CFS) – must be legalized by the consular.
e) Documentation proving the efficacy of the product or its components, which have been publicly disclosed.
f) Dosage table, Recommended Nutrient Intake (RNI) table.
g) Product specifications (SPEC).
h) Product label sample.
i) Planned supplementary labeling content
3. Certificate of Advertising Content Confirmation for Health supplement
The application for a certificate of advertising content confirmation includes:
a) Application form for confirmation of the desired advertising content for the product.
b) Registration number for the product declaration and the Product Declaration (already confirmed by the authorized agency).
c) Product label sample (approved by the agency issuing Registration number for product declaration).
d) In case of advertising in newspapers, magazines, scripts, and expected advertising content must be provided (recorded on video or audio discs); for advertising on other media, a sample of the expected advertising content must be provided (confirmed by the entity wishing to advertise the product).
The establishment must obtain a certificate of eligibility for food safety.
(According to Circular No. 29/2012/TT-BCT: regulations on issuance, withdrawal, and certification of facility meeting food safety conditions under the management responsibility of the Ministry of Industry and Trade)
The dossier for the Certificate of Eligibility includes:
1. A request form for the issuance of the Certificate of Eligibility for food safety.
2. A notarized copy of the business registration certificate.
3. A description of the infrastructure, equipment, and tools ensuring food safety conditions.
4. An original or notarized copy of the certificate confirming that the business owner has received training on food safety and hygiene, or a list of employees directly engaged in business operations designated by the competent authority under the Ministry of Industry and Trade regulations.
5. An original or notarized copy of the health certificate of the business owner and the direct business operator, or a list of employees directly engaged in business operations issued by the district/commune-level health authority as stipulated.
Conditions for the stores:
– Sufficient area to arrange display areas, storage areas, and convenient for transportation of raw materials and food products.
– Not prone to flooding, waterlogging, or affected by animals, insects, and other sources of pollution.
– Smooth, brightly colored walls and ceilings, made of durable, sturdy materials, not prone to decay, water leakage, cracking, moss, waterlogging, or clinging to dirt.
– The hygiene area must be separated from the business area; toilet doors must not open directly into the storage area.
– A transparent record-keeping system or management software must be in place throughout the business process.
– For import establishments, there must be a warehouse or designated storage area that meets the manufacturer’s storage requirements.
– Business of health supplements within pharmacies must have separate display areas, signage, and labeling for health supplements.
For consultation on MEDGATE’s registration and import-export services, please contact us at the Hotline 098.546.1894 or send a message via our fan page for immediate assistance.