Product Registration and Declaration

Do you want your product to be recognized and released on the market safely and legally? Explore the Product Registration and Declaration service provided by Asia Life Health Supplement Manufacturing Plant to protect and grow your brand:

“The Product Registration and Declaration Service by Asia Life Health Supplement Manufacturing Plant: Protecting and Developing Your Brand”

What are the procedures for declaring health supplements?

– The procedure for declaring health supplements is a requirement for individuals engaged in the health supplement business to ensure that their products can circulate in the Vietnamese market.

– Health supplements are among the products that must undergo product declaration registration according to the regulations stated in Article 6 of Decree 15/2018/ND-CP. Therefore, the procedure for declaring health supplements essentially involves product declaration registration.

When should the procedure for declaring health supplements be carried out?

– Health supplements manufactured domestically or imported from abroad must undergo the procedure for declaring health supplements before being allowed to circulate in the market

5 Reasons Why Businesses Need to Register Health Supplement Declarations

Health supplements are widely favored by Vietnamese consumers nowadays. However, these products directly impact consumers’ health, so the government has mandated that they must obtain a declaration dossier issued by the Food Safety Department. This requirement is essential for the following reasons, as explored by Asia Life:

  • Avoiding penalties during regulatory inspections

As mentioned earlier, the declaration of health supplements is one of the mandatory regulations and is legalized in legal documents. Failure to comply with this law will naturally result in penalties as stipulated, with fines for health supplements up to 40 million VND. Therefore, ensuring product quality through declaration before market distribution will provide peace of mind and legal compliance for businesses.

  • Protecting consumer health

To obtain a quality declaration for health supplements, manufacturing and trading facilities must ensure product quality according to the specified criteria. When the products comply with the criteria and pass scrutiny, consumer health is protected.

  • Building brand reputation

The declaration of health supplements signifies that these products have been tested for food safety and are legally permitted for circulation. With legal credibility established, these products will quickly gain consumer trust and acceptance. Being trusted is akin to building brand reputation and gradually gaining a foothold in the market.

  • Enhancing competitiveness

In a society where concerns about contaminated and low-quality food products prevail, having your product scrutinized and authorized for circulation by regulatory authorities will undoubtedly elevate your product and your company’s competitiveness in the market, especially compared to products that have not been declared.

As consumers prioritize quality, certified health supplements become their top choice, spreading through word of mouth. Consequently, your products will quickly outperform competitors, boosting sales figures.

  • Maintaining product quality stability

Once health supplement products are registered for quality, individuals still need to ensure that the quality meets the standards submitted to the Food Safety Authority. According to current laws, government agencies have the right to conduct surprise inspections on any declared product at any time. Moreover, maintaining product stability is a way for businesses to earn consumer trust.

Therefore, it is evident that the declaration of health supplements plays a crucial role in the development process, brand building, and compliance with current legal regulations. Understanding the reasons for declaration, now is the time for your organization to declare health supplements.

Conditions for conducting the procedure for declaring health supplements

 Conditions of the establishment:

+The organization conducting the declaration procedure must have a business registration and engage in the production and trading of food products.

+ Facilities producing and trading health supplements must ensure that they meet the requirements for food safety conditions. Specifically, they must have one of the following certificates: Good Manufacturing Practice (GMP) certificate or a certificate of compliance with food safety conditions.

 Conditions of the product:

+Health supplement products imported from abroad must have a certificate of free circulation, a Certificate of Exportation, or a health certificate issued by the exporting country’s authority to ensure that the product can be freely circulated in the export market.

+The product must undergo quality testing to ensure compliance with safety criteria set by the Ministry of Health based on risk management principles consistent with international regulations or safety criteria according to corresponding standards established by organizations or individuals in cases where there are no regulations from the Ministry of Health.

*For imported products, the dossier includes:

Product declaration form

Certificate of Free Sale or Certificate of Exportation or Health Certificate issued by the competent authority of the exporting country, ensuring the safety for users or freely sold in the market of the manufacturing/exporting country (legalized by the consulate).

Test results for food safety of the product within 12 months from the submission date issued by designated testing laboratories or laboratories recognized according to ISO 17025, including safety criteria set by the Ministry of Health based on risk management principles consistent with international regulations or safety criteria according to corresponding standards established by organizations or individuals in cases where there are no regulations from the Ministry of Health (original or authenticated copy).

Scientific evidence demonstrating the efficacy of the product or its active ingredients, which has been published (original or copy authenticated by the organization or individual). When using scientific evidence regarding the efficacy of the product’s ingredients to support the product’s claims, the minimum daily dosage of the product must be equal to or greater than 15% of the dosage of that ingredient as stated in the documentation.

Certificate of compliance with Good Manufacturing Practices (GMP) or equivalent certification in the case of imported products, applicable to health supplements starting from July 1, 2019 (authenticated copy by the organization or individual).

*For domestically manufactured products, the dossier includes:

– Product declaration document

Safety testing results of the product within a 12-month period from the submission date, issued by an accredited testing laboratory or a laboratory recognized to comply with ISO 17025 standards, comprising safety criteria regulated by the Ministry of Health according to risk management principles consistent with international regulations or safety standards corresponding to those published by organizations or individuals in cases where there are no regulations from the Ministry of Health (original or certified copy).

Scientific evidence proving the efficacy of the product or its constituent components, already published (original or certified copy with confirmation from organizations or individuals). When utilizing scientific evidence regarding the efficacy of product components to substantiate the product’s efficacy, the daily dosage of the product must be at least 15% greater than or equal to the dosage of the mentioned component as stated in the documentation.

-Certificate of compliance with food safety requirements in cases where the facility falls under the category requiring a certificate of compliance with food safety conditions as stipulated (certified copy with confirmation from organizations or individuals).

-Certificate of compliance with Good Manufacturing Practice (GMP) requirements in cases where the domestically manufactured product is a health food product, effective from July 1, 2019 (certified copy with confirmation from organizations or individuals).

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