– Decree No. 155/2018/ND-CP issued on November 12, 2018: Amending and supplementing certain regulations related to conditions for investment and business within the state management scope of the Ministry of Health.
– Decree No. 93/2016/ND-CP issued on July 1, 2016: Regulations on the conditions for cosmetic production.
Cosmetic production facilities must meet the following conditions:
1. Personnel: The person in charge of production must have expertise in one of the following fields: Chemistry, Biology, Pharmacy, or other related fields that meet the job requirements.
2. Infrastructure Conditions:
a) A location, area, workshop, and equipment that meet the requirements for the production line and the type of cosmetic products intended to be manufactured, as specified in the application for the Certificate of Eligibility for Cosmetic Production.
b) Storage areas for raw materials, packaging materials, and finished products must ensure separation between raw materials, packaging materials, and finished products. There should be a designated area for storing flammable and explosive substances, highly toxic substances, rejected materials, and products subject to recall.
3. Quality Management System: The facility must have a quality management system meeting the following requirements:
a) The water used in cosmetic production must meet national technical standards for drinking water issued by the Minister of Health.
b) Have a production process for each product.
c) Have a quality control department to inspect the quality of raw materials, semi-finished products, products awaiting packaging, and finished products.
The Department of Health issues the Certificate of Eligibility for Cosmetic Production for cosmetic production facilities
a) Application for the Certificate of Eligibility for Cosmetic Production.
b) Layout plan and design of the production facility.
c) List of existing equipment at the production facility.
Application for the reissuance of the Certificate of Eligibility for Cosmetic Production.
Eligibility for manufacturing cosmetics
1. Before commencing production, the cosmetic production facility submits an application for the Certificate of Eligibility for Cosmetic Production to the Department of Health where the facility is located.
2. Within 30 working days from the date of receiving a valid application and the specified assessment fee, the Department of Health conducts an inspection of the production facility and issues the Certificate of Eligibility for Cosmetic Production. If the certificate is not issued or if changes are required, the Department of Health must notify the production facility in writing, stating the reasons.
3. In cases where changes are required:
a) The cosmetic production facility makes changes and submits a report to the Department of Health.
b) The Department of Health reviews the report, inspects the facility if necessary, and within 15 working days from receiving the report, provides a written response on the inspection results to the production facility.
c) Within 6 months from the date of issuing the notification requesting changes, if the Department of Health does not receive the facility’s report on changes, the application for the Certificate of Eligibility for Cosmetic Production becomes invalid.
4. For cosmetic manufacturers that have been granted the “Good Manufacturing Practice for Cosmetics” certificate (CGMP-ASEAN) by the Ministry of Health:
a) The Ministry of Health shall send a written communication to the Department of Health where the cosmetic production facility is located regarding the issuance of the Certificate of Eligibility for Cosmetic Production.
b) Within a period of 5 working days from the date of receiving the communication from the Ministry of Health, the Department of Health is responsible for issuing the Certificate of Eligibility for Cosmetic Production to these cosmetic production facilities.
Within 5 working days from the date the Department of Health receives the request from the cosmetic production facility, it reissues the Certificate of Eligibility for Cosmetic Production.
For consultation on MEDGATE’s registration and import-export services, please contact us at the hotline 098.546.1894 or send a message via our fan page for immediate assistance.
Please leave complete and accurate information, Medgate will contact you immediately within 24 hours for free consultation and answer your questions.
Tiếng Việt