CONDITION FOR MANUFACTURING COSMETIC

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04Jul

CONDITION FOR MANUFACTURING COSMETIC

  1. CONDITION FOR MANUFACTURING COSMETIC

The operating conditions of a cosmetic manufacturer

  1. Must be established under the Vietnamese law;
  2. Have obtained a Certificate of eligibility for cosmetic manufacturing according to the Form No. 01 in the degree 93/2016/NĐ-CP.

 

Conditions for issuance of Certificate of eligibility for cosmetic manufacturing

 

No

Requirement

Description

1

Personnel

The production manager must have professional knowledge as chemistry, biology, pharmacy or other relevant majors.

2

Infrastructure

a. There is a located facilities and equipment.

b. Warehouse of raw materials, packaging materials and finished goods must ensure the separation between them. There are separate areas to store inflammable, high potent substances; reject, return, recall products.

3

Quality management system

a)Raw materials and auxiliary materials used to manufacture cosmetic products must meet the manufacturer’s specification.

b) The water used to manufacture cosmetic products at least meet national technical regulation on drinking water quality issued by Ministry of Health.

c) A semi-finished product used in the production must have specification and meet that specification.

d) There is manufacturing process for each product.

đ) There is a quality control department to test the quality of raw materials, semi-products, bulk products and finished goods.

e)Documentation system must be available

Forms of issuance of Certificates of eligibility for cosmetic manufacturing

Dossier for issuance/re-issuance of Certificate of eligibility for cosmetic manufacturing

  1. A Dossier for issuance of Certificates of eligibility for cosmetic manufacturing:
  2. a) The application form 02 in Decree 93/2016/NĐ-CP;
  3. b) The site plans and design drawings;
  4. c) The list of existing equipment;
  5. d) The list of portfolios which are produced and specification of each product type.

 

  1. The application for re-issuance of Certificate of eligibility for cosmetic manufacturing:
  2. a) The application Form No. 03 in the Decree 93/2016/NĐ-CP;
  3. b) The original of Certificate of eligibility for cosmetic manufacturing (if any).

 

Procedures for issuance of Certificate of eligibility for cosmetic manufacturing

Step 1: The dossier shall be sent directly or by post to Department of Health

Step 2:  

  • Within 02 days, Department of Health shall check the dossier:
  1. a) Issue a Receipt note according to the Form No. 05 in Decree 93/2016/NĐ-CP if the dossier is sufficient and valid;
  2. b) Make a written notice of insufficient or invalid contents.
  • Within 05 days, Department of Health shall re-issue Certificate of eligibility for cosmetic manufacturing using Form No. 01 in Decree 93/2016/NĐ-CP.

Step 3: Within 30 days, Department of Health shall inspect the cosmetic manufacturer:

  • Issue Certificate of eligibility for cosmetic manufacturing
  • Or give a written notice to specify reasons thereof or a written request for change or remedy

Step 4: Within 15 days,  Department of Health shall examine the cosmetic manufacturer’s report;

 

Note: Within 06 months, if the manufacturer fails to submit the report on corrective action report to Department of Health, the submitted dossier shall be invalid.

 

  1. IMPLEMENTATION

This Decree comes into force from July 01, 2016.

 

Transitional provision

  1. Cosmetic manufacturers which have operated before the effective date of this Decree may continue their operations to make types of cosmetic products with effective receipt number of the Notification of cosmetic products provided that the procedures for issuance of Certificate of eligibility for cosmetic manufacturing must be made as referred to in this Decree before December 31, 2018.
  2. If cosmetic manufacturers which have operated before the effective date of this Decree want to produce types of cosmetic products other than those being issued with receipt number of the Notification of cosmetic products, they must carry out the procedures for issuance of Certificate of eligibility for cosmetic manufacturing as referred to in this Decree before starting that production of new types of cosmetic products.
  3. Ministry of Health shall provide the list of cosmetic manufacturers to which it has granted “Cosmetic Good Manufacturing Practices (CGMP-ASEAN)” Certificates before the effective date of this Decree to Departments of Health in order to issue Certificates of eligibility for cosmetic manufacturing to them before December 31, 2016.
  4. During their operation, cosmetic manufacturers shall adopt the quality management system in compliance with “Cosmetic Good Manufacturing Practices (CGMP-ASEAN)” guidelines and standards.