Procedures for issuance of Certificates of eligibility for cosmetic manufacturing in Vietnam

Procedures for issuance of Certificates of eligibility for cosmetic manufacturing in Vietnam (Internet image)

Regarding this issue, LawNet responded as follows:

1. Conditions for issuance of Certificate of eligibility for cosmetic manufacturing in Vietnam

According to Article 4 of Decree 93/2016/ND-CP (amended by Decree 155/2018/ND-CP), 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, auxiliary materials and semi-finished products which are used to manufacture cosmetic products must satisfy the 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 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;

2. Procedures for issuance of Certificates of eligibility for cosmetic manufacturing in Vietnam

2.1. Application for issuance of Certificates of eligibility for cosmetic manufacturing in Vietnam

An application for issuance of Certificates of eligibility for cosmetic manufacturing shall consist of the following documents:

- The application form for issuance of Certificate of eligibility for cosmetic manufacturing using Form No. 02 in the Annex enclosed with Decree 93/2016/ND-CP;

Form No. 02

- The site plans and design drawings of the cosmetic manufacturer;

- The list of existing equipment of the cosmetic manufacturer;

* Note: The said documents must be fan-stamped by the cosmetic manufacturer and make up 01 set of the application dossier for issuance/re-issuance of Certificate of eligibility for cosmetic manufacturing.

(Clause 1 and 3, Article 7 of Decree 93/2016/ND-CP (amended by Decree 155/2018/ND-CP))

2.2. Procedures for issuance of Certificates of eligibility for cosmetic manufacturing in Vietnam

Procedures for issuance of Certificates of eligibility for cosmetic manufacturing in Vietnam includes the following steps:

Step 1:  Before carrying out its operation, the cosmetic manufacturer must submit the application for issuance of Certificate of eligibility for cosmetic manufacturing to Department of Health.

The application shall be, by hand or by post, submitted to Department of Health where the cosmetic manufacturer’s workshop is located.

Step 2: Within 02 working days from the receipt of the application for issuance/re-issuance of Certificate of eligibility for cosmetic manufacturing, Department of Health shall check the application and perform one of the following acts:

- Issue a Receipt note according to the Form No. 05 in the Annex enclosed with v if the application is sufficient and valid as referred to in Section 2.1;

Form No. 05

- Make a written notice of insufficient or invalid contents.

Step 3: Within 30 working days from the receipt of the valid application and appraisal fees as regulated, Department of Health shall inspect the cosmetic manufacturer and issue Certificate of eligibility for cosmetic manufacturing to that cosmetic manufacturer.

In case the application is rejected or there are rectifications to be made by the applicant, Department of Health shall give a written notice to specify reasons thereof or a written request for change or remedy.

In which, in cases where the cosmetic manufacturer is requested to make certain rectifications:

- The cosmetic manufacturer must make rectifications and send rectification report to Department of Health;

- Department of Health shall examine the cosmetic manufacturer’s report, compare with the application or carry out re-inspection of the cosmetic manufacturer’s base (where necessary).

Within 15 days from the receipt of the report on remedial results, the inspection agency must provide inspection results in writing;

- Within 06 working days from the date on which the written request for rectifications is sent to the cosmetic manufacturer, if that cosmetic manufacturer fails to submit the report on remedial results to Department of Health, the submitted application for issuance of Certificate of eligibility for cosmetic manufacturing shall be invalid.

In addition, with regard to cosmetic manufacturers that have “Cosmetic Good Manufacturing Practices (CGMP-ASEAN)” Certificates granted by Ministry of Health:   

- Ministry of Health shall send official dispatches to Departments of Health where workshops of such cosmetic manufacturers are located with respect to the issuance of Certificates of eligibility for cosmetic manufacturing;

- Within 05 working days from the receipt of the official dispatch sent by Ministry of Health, Departments of Health shall issue Certificates of eligibility for cosmetic manufacturing to such cosmetic manufacturers.

(Article 8, Article 9 of Decree 93/2016/ND-CP)

Nguyen Thi Hoai Thuong

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