What to do to manufacture cosmetics?

Posted date: 13/11/2020

My company wants to cooperate with another company to produce cosmetics. Let me ask you this “Do I need to apply for a license to manufacture cosmetic products”? If it is necessary, what is the procedure?

FDVN's opinion:

Pursuant to the provisions of Article 3 of Decree No. 93/2016 / ND-CP dated July 1, 2016 of the Government on conditions for manufacture of cosmetic products and Decree No. 155/2018 / ND-CP dated November 12. / 2018 of the Government amending regulations related to business investment conditions under the state management scope of the Ministry of Health, Requirements to be satisfied by cosmetic manufacturers is obtained a Certificate of eligibility for cosmetic manufacturing.

As such, your company needs to carry out procedures for issuing the Certificate of eligibility for cosmetic manufacturing before the operation.

1. Conditions for the issuance of a Certificate of eligibility for cosmetic manufacturing (Article 4 of Decree No. 93/2016 / ND-CP dated July 1, 2016, amended and supplemented by Decree No. 155/2018 / ND-CP):

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 the 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 granting the Certificate of eligibility for cosmetic manufacturing:

Dossiers:

The application form for issuance of Certificate of eligibility for cosmetic manufacturing using Form No. 02 in the Annex enclosed with this Decree;
The site plans and design drawings of the cosmetic manufacturer;
The list of existing equipment of the cosmetic manufacturer;

Competent authorities (Article 5 of Decree 93/2016 / ND-CP): Departments of Health shall issue Certificates of eligibility for cosmetic manufacturing to local cosmetic manufacturers.

Procedures:

Apply to the competent State agency
Within 30 working days from the receipt of the valid application and appraisal fees as regulated, the Department of Health shall inspect the cosmetic manufacturer and issue a Certificate of eligibility for cosmetic manufacturing to that cosmetic manufacturer. In case the application is rejected or is requested rectifications, the Department of Health shall make a written notice to specify reasons thereof or a written request for change or remedy.
In cases the location of the cosmetic manufacturer is requested to make certain rectifications:
The cosmetic manufacturer must make rectifications and send a certification report to the 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.
With regard to cosmetic manufacturers that have “Cosmetic Good Manufacturing Practices (CGMP-ASEAN)” Certificates granted by the Ministry of Health:
Ministry of Health shall send official dispatches to Departments of Health about 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 the Ministry of Health, Departments of Health shall issue Certificates of eligibility for cosmetic manufacturing to such cosmetic manufacturers.

Above is FDVN Law Firm's advisory opinion regarding the request of a consultant of the Guest on the basis of studying legal regulations. Hopefully, FDVN's advice will be helpful to you.

Legal expert: Hoang Thuy Quynh

FDVN Law Firm

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