What traders need to do when QCVN 20-1:2024/BYT applies to health supplements/dietary supplements/food supplements takes effect

In previous articles, we have provided our Clients with an overview of Health Supplements/ Dietary Supplements/Food Supplements (“HS/DS/FS”), details of the contaminants that HS/DS/FS products must comply with when applying the National Technical Regulation QCVN 20-1:2024/BYT (“NTR”). Following them, in this article, Apolat Legal will provide you with some points that Clients should pay attention to at the time of application of NTR.  

See more: Detailed contents to comply with NTR no. 20-1:2024/byt for health suppement/deitary supplement groups

As far as we know, NTR shall be applied starting from 01/8/2025. Accordingly, many people will wonder how the previous approved registration dossiers for the HS/DS/FS that have been granted the licenses before the effective date of the NTR will apply.

For this concern, clause 3, Article 3 of Circular No. 12/2024/TT-BYT promulgating NTR has provided for the transition on the application of NTR as follows: “From the effective date of this Circular, for health supplements/dietary supplements granted a certificate of registered product disclosure, if the manufacturer’s standard is yet to conform to the technical regulation promulgated with this Circular, organizations or individuals must adjust the manufacturer’s standard to make it conformable with the technical regulation and submit a notification as prescribed in clause 4 Article 8 of the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of some Articles of the Law on Food Safety”.

In order to comply with the above regulations, Apolat Legal recommends the traders can consider performing some of the following tasks:  

Step 1: Reviewing the Manufacturer’s Product Specification for each product to update the safety criteria in accordance with NTR into the Product Specification;  

Step 2: Issuing the Manufacturer’s revised version of the Product Specification;  

Step 3: Drafting the Notice of change in the contents of the Manufacturer’s Product Specification;  

Step 4: Signing, sealing and preparing documents related to the product to be notified of the change; 

Step 5: Submitting the Notice of change in the Manufacturer’s Product Specification to the competent state agency;  

Step 6: Filling the records that have been notified of changes at the Company. Controlling the product quality control for safety criteria updated according to NTR in the process when circulating products on the market. 

Note: For imported HS/DS/FS products, the Product Specification is usually issued by the Manufacturer in a foreign language. Therefore, when bring it to Vietnam for use, the Clients need to pay attention to the notarized translation of documents into Vietnamese before submitting the Notice of change to the competent state agency. In addition, according to Apolat Legal’s experience, in some cases, the Manufacturer is only an outsourcing company/unit and does not issue the Product Specification. In this case, the Product Specification is issued by the product owner. At that time, the Clients may have to collect and prepare additional documents proving that the Manufacturer also knows, agrees and manufactures the product according to the Product Specification that has been updated/changed by the Product Owner.  

Above are some of the contents of legal regulations and practices in fact that Apolat Legal provides to Clients in order to support Clients to better understand and conveniently apply at the time of transfer of application between the current legal regulations and new regulations.  

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