Legal basis

• Law on Investment 2014
• Decree 155/2018/ND-CP amending and supplementing several regulations related to business investment conditions under the scope of state management of the Ministry of Health
• Decree 93/2016/ND-CP- Regulations on cosmetic production conditions

Conditions

Cosmetic manufacturing establishments must meet the following conditions:

• Conditions of personnel: The person in charge of the production of the establishment must have professional knowledge in one of the following specialties: chemistry, biology, pharmacy, or other related disciplines that meet the requirements of the job.
• Conditions of facilities:
  • Having a location, area, workshop, and equipment that meet the requirements of the production line and the type of cosmetic product that the establishment intends to produce as stated in the application file for the Certificate of eligibility for cosmetic production;
  • Warehouses for storing raw materials, packaging materials, and finished products must ensure separation between raw materials, packaging materials, and finished products; has a separate area for storing flammable and explosive substances, highly toxic substances, rejected, recalled, and returned raw materials, materials and products.
• Conditions on the quality management system:
  • Raw materials, auxiliary materials, and semi-finished products used in the production of cosmetics must meet the quality standards of the manufacturer;
  • Water used in cosmetic production must at least meet the national technical regulations on drinking water promulgated by the Minister of Health;
  • Having a production process for each product;
  • Having a quality inspection department to check the quality of raw materials, semi-finished products, products awaiting packing, and finished products.

The procedures

Step 1: Before starting production, the cosmetic manufacturer submits an application for a Certificate of eligibility for cosmetic production to the Department of Health.

Step 2: Within 02 working days from the date of receipt of the application for the Certificate of eligibility for cosmetic production, the Department of Health is responsible for checking the application file and issuing the application receipt form according to the form. No. 05 specified in the Appendix issued together with the Government’s Decree No. 93/2016/ND-CP dated July 1, 2016, stipulating the conditions for cosmetic production if the dossier is complete and valid. In case the dossier is incomplete and invalid, a written notice shall be given and stating the incomplete and invalid contents to the cosmetic manufacturing establishment.

Step 3: Within 30 days from the date of receiving the valid application and appraisal fee as prescribed, the Department of Health is responsible for inspecting the production facility and issuing the Certificate of eligibility for cosmetic production; in case of refusal to issue the certificate or request the establishment to change or remedy, it must notify in writing and clearly state the reason.

The dossiers

• An application form for a Certificate of eligibility for cosmetic production, made according to Form No. 02 specified in the Appendix issued together with the Government’s Decree No. 93/2016/ND-CP dated July 1, 2016, on regulations on cosmetic production conditions;
• Floor plan and design of the production facility;
• List of existing equipment of the production facility;

The competent authority

Health service Department

If you need more detailed advice and answers as well as how to access this service, please contact directly our Lawyer Nhat Nam via hotline: 0912.35.65.75, 0912.35.53.53 or call the toll free legal consultation hotline 1900.6575 or send a service request via email: lienheluathongbang@gmail.com

Wishing you and your family good health, peace, and success!

Best regards!