What are conditions for production of dietary supplements in Vietnam?

1. What are conditions for production of dietary supplements in Vietnam?

Pursuant to Clause 1, Article 28 of Decree 15/2018/ND-CP, food safety requirements in production of dietary supplements are as follows:

1. Manufacturers of dietary supplements shall satisfy general food safety conditions specified in Clause 1 Article 19, Clause 1 Article 20 and Clause 1 Article 21 of the Law of Food safety and the following regulations:

a) Establish and maintain a quality control system which control the manufacture and distribution in order to ensure that all products satisfy the applied standards and are safe until their expiration;

b) Hire employees whose qualifications are suitable for their positions and are trained in GMP, food safety and relevant knowledge. The head of the production department and quality control department must be full-time employees and work independently from one another. The chief supervisor of the facility must have at least a bachelor’s degree in medicine, pharmacy, nutrition, food safety or food processing technology and 3 years' working experience in a relevant field;

c) The factory, equipment and auxiliary utilities are installed suitable for their purposes, following one-way rules, easy to clean, not confusing, able to prevent dust, pollution and other elements detrimental to product quality. They must be cleaned on a daily basis;

d) Retain documents about the manufacture process, quality control and distribution in a manner that the history of every batch can be accessed, and documents about other activities at the facility;

dd) All tasks must be performed in accordance with procedures and instructions. Carry out inspections and supervision during the manufacture process to avoid confusion, pollution and cross-contamination. Record the result immediately after a process is done;

e) Establish a quality control department to ensure that the products are manufactured under conformable conditions and processes; necessary tests are run; use of raw materials and sale of products are not approved before the quality is satisfactory; product stability must be monitored;

g) In case of testing or production under a contract, the contractor shall have adequate equipment and personnel to satisfy requirements of the hirer, satisfy requirements for testing or production of dietary supplement established by a competent authority.

h) There are procedures for complaint settlement, product recall, self-inspection; documents about these tasks must be retained in full.

Thus, if your intention is to open a supplement manufacturing company in Vietnam, please refer to the conditions outlined above.

2. What are procedures for issuance of the certificate of GMP for dietary supplements in Vietnam? 

According to Clause 2, Article 29 of Decree 15/2018/ND-CP, there are regulations on procedures for issuance and reissuance of the certificate of GMP for dietary supplements as follows:

2. Procedures for issuance of the certificate of GMP for dietary supplements

a) An application specified in Clause 1 of this Article shall be submitted to the Ministry of Health directly, by post or through the online public service system;

b) Within 15 working days from the receipt of the satisfactory application, the receiving authority shall establish an inspectorate, which will to carry out a site inspection and issue the inspection record according to form No. 13 in Appendix I hereof.

The inspectorate shall consist of at least 5 people, 2 of whom are experienced in GMP, and 1 person is specialized in testing.

c) If the inspection result is satisfactory, the receiving authority shall issue the certificate of GMP for dietary supplements (Form No. 14 in Appendix I hereof) within 30 days from the receipt of the application;

d) 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.

Best Regards!