Procedures for issuance of certificates of eligibility for the production of cosmetic

1

Implementing agency

Department of Health of the province where the cosmetic manufacturing facility is located.

2

Means of application

The cosmetic manufacturer applying for the Certificate of eligibility to manufacture cosmetic (“cosmetic manufacturer”) shall submit an application in one of the following forms:

• In person; or
• By mail.

3

Dossier components

01 dossier includes[1]:

General requirements documents:

a. An application for a Certificate of eligibility for cosmetic manufacturing according to Form No. 02 specified in the Appendix enclosed with Decree 93/2016/ND-CP.

b. Site plan and design of the cosmetic manufacturer.

c. The existing equipment catalog of the cosmetic manufacturer.

Form requirement: Original, stamped between pages.

4

Fee, charges

VND 6,000,000/ cosmetic manufacturer[2].

5

Result

Certificate of Eligibility for Cosmetic Manufacturing (“Certificate”).

Personnel

Personnel conditions must be met[3]:

The individuals in charge of the facility's production must have professional knowledge of one of the following specialties: Chemistry, biology, pharmacology, or other relevant disciplines that meet the requirements of the job.

Facilities

Conditions on facilities must meet[4]:

a. Its locations, areas, workshops and equipment must meet the requirements on production lines and types of cosmetic products that such cosmetic manufacturers plan to produce as outlined in the dossier of application for a Certificate.

b. Warehouses for preserving raw materials, packaging materials and finished products must ensure separation between raw materials, packaging materials and finished products; There are separate areas for storing flammable and explosive substances, highly toxic substances, discarded, recalled and returned materials and products.

Quality management system

The quality management system of the cosmetic manufacturing facility must meet the following requirements[5]:

a. Raw materials, auxiliary materials and semi-finished products used in cosmetics production must meet the manufacturer's quality standards.

b. Water used in the production of cosmetics must meet national technical regulations on drinking water quality promulgated by the Minister of Health.

c. There is a production process for each type of cosmetic product.

d. There is a quality inspection department to check the quality of raw materials, semi-finished products, bulk products and finished products.

Note

For cosmetic manufacturers that have been issued the Certificate of “Cosmetic Good Manufacturing Practice” (CGMP-ASEAN) by the Ministry of Health, cosmetic manufacturers are not required to follow the order of application for the certificate as stated herein. Instead, the Ministry of Health will request the Department of Health to issue a Certificate for Enterprises[6].