Conditions for issuance of Certificate of eligibility for cosmetic manufacturing in Vietnam: Important points

Specifically, according to Article 4 of the Decree No. 93/2016/NĐ-CP, Articles 12 and 13 of Decree No. 155/2018/NĐ-CP of Vietnam’s Government, a cosmetic manufacturer may be qualified to apply for a Certificate of eligibility for cosmetic manufacturing if it satisfies all of the following conditions:

Personnel requirement: The production manager must have professional knowledge about one of the following majors: Chemistry, Biology, Pharmacy or other relevant majors in order to meet job requirements.

Infrastructure requirement:

- Its location, area, workshop and equipment must meet requirements on the production line and types of cosmetic products which will be produced by that manufacturer as described in the application dossier for Certificate of eligibility for cosmetic manufacturing;

- Raw materials, packaging materials and finished products stores must ensure the separation between raw materials, and packaging materials, and finished products, and have separate areas for storing flammable and explosive matters, highly toxic substances, discharged or recalled or returned materials or products.

Its quality management system must satisfy the following requirements:

- Raw materials and auxiliary materials used to manufacture cosmetic products must meet quality standards adopted by the manufacturer;

- The water used in the production of cosmetic products must comply with the national technical regulations on drinking water quality promulgated by Minister of Health;

- The quality standards of semi-finished products used in the production must meet the manufacturer’s ones;

- The production process must be available for each type of cosmetic products;

- The quality of raw materials, semi-finished products, bulk products and finished products must be monitored by quality control divisions;

- Documentation system must be available.

Departments of Health shall issue Certificates of eligibility for cosmetic manufacturing to local cosmetic manufacturers.

Besides, according to current regulations, certificates of eligibility for cosmetic manufacturing shall be revoked by the issuing authorities in the following cases:

- A cosmetic manufacturer fails to meet all of conditions set forth above;

- A Certificate of eligibility for cosmetic manufacturing has been issued by an incompetent authority or includes unlawful contents;

- A cosmetic manufacturer runs its operations at a location other than that stated in the issued Certificate of eligibility for cosmetic manufacturing;

- The application for issuance/re-issuance/amendment of Certificate of eligibility for cosmetic manufacturing has been forged;

- A cosmetic manufacturer voluntarily applies for the revocation of Certificate of eligibility for cosmetic manufacturing.

Thus, according to the above regulations, cosmetic manufacturers must satisfy all requirements on personnel, infrastructure and quality management system to be issued a Certificate of eligibility for cosmetic manufacturing. In cases that the cosmetic manufacturer fails to meet all of the conditions, the application for issuance/re-issuance/amendment of Certificate of eligibility for cosmetic manufacturing has been forged, etc. such certificates shall be revoked.

Nguyen Trinh

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