Decree No. 93/2016/ND-CP dated July 01, 2016, providing for conditions for manufacture of cosmetic products

DECREE

PROVIDING FOR CONDITIONS FOR MANUFACTURE OF COSMETIC PRODUCTS

Pursuant to the Law on Organization of the Government dated June 19, 2015;

Pursuant to the Law on Investment dated November 26, 2014;

At the request of Minister of Health;

The Government promulgates this Decree to provide for conditions for manufacture of cosmetic products.

Chapter 1

GENERAL PROVISIONS

Article 1. Scope and regulated entities

This Decree provides for conditions for manufacturers of semi-finished cosmetic products, manufacturers of finished cosmetic products and cosmetic packaging establishments (hereinafter referred to as cosmetic manufacturers), and procedures for issuance, re-issuance, amendment and revocation of Certificates of eligibility for cosmetic manufacturing.

Article 2. Interpretation of terms

In this Decree, these terms shall be construed as follows:

1. Cosmetic product is a substance or a preparation intended to be placed in contact with the various external parts of the human body (skin, hair system, finger nails, toenails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, correcting body odours or keeping the human body in good condition.

2. Semi-finished cosmetic product refers to a product that has not been completely manufactured, and has to undergo one or several production stages, or packaging process to become a finished cosmetic product.

Chaprter II

CONDITIONS FOR MANUFACTURE OF COSMETIC PRODUCTS

Article 3. Requirements to be satisfied by cosmetic manufacturers

1. A cosmetic manufacturer must be established under the law; and

2. Have obtained a Certificate of eligibility for cosmetic manufacturing according to the Form No. 01 in the Annex enclosed with this Decree.

Article 4. Conditions for issuance of Certificate of eligibility for cosmetic manufacturing

A cosmetic manufacturer may be qualified to apply for a Certificate of eligibility for cosmetic manufacturing if it satisfies all of the following conditions:

1. 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.

2. Infrastructure requirement:

a) 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;

b) 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.    

3. Its quality management system must satisfy the following requirements:

a) Raw materials and auxiliary materials used to manufacture cosmetic products must meet quality standards adopted by the manufacturer;

b) The water used in the production of cosmetic products must comply with the national technical regulations on drinking water quality promulgated by Minister of Health;

c) The quality standards of semi-finished products used in the production must meet the manufacturer’s ones;

d) The production process must be available for each type of cosmetic products;

dd) The quality of raw materials, semi-finished products, bulk products and finished products must be monitored by quality control divisions;

e) Documentation system must be available.

Chaprter III

POWER, APPLICATION AND PROCEDURES FOR ISSUANCE OF CERTIFICATES OF ELIGIBILITY FOR COSMETIC MANUFACTURING

Article 5. Power to issue Certificates of eligibility for cosmetic manufacturing

Departments of Health shall issue Certificates of eligibility for cosmetic manufacturing to local cosmetic manufacturers.

Article 6. Forms of issuance of Certificates of eligibility for cosmetic manufacturing

1. A Certificate of eligibility for cosmetic manufacturing shall be issued in the following cases:

a) A cosmetic manufacturer applies for Certificate of eligibility for cosmetic manufacturing;

b) A cosmetic manufacturer that has Certificate of eligibility for cosmetic manufacturing issued moves its production location;

c) A cosmetic manufacturer that has Certificate of eligibility for cosmetic manufacturing issued supplements its production line other than that stated in the issued Certificate of eligibility for cosmetic manufacturing.

2. The re-issuance of Certificates of eligibility for cosmetic manufacturing shall be applied to the cases where the issued Certificates of eligibility for cosmetic manufacturing are lost or damaged.

Article 7. Application for issuance/re-issuance of Certificate of eligibility for cosmetic manufacturing

1. An application for issuance of Certificates of eligibility for cosmetic manufacturing shall consist of the following documents:

a) The application form for issuance of Certificate of eligibility for cosmetic manufacturing using Form No. 02 in the Annex enclosed with this Decree;

b) The site plans and design drawings of the cosmetic manufacturer;

c) The list of existing equipment of the cosmetic manufacturer;

d) The list of types of cosmetic products which are undergoing the production or will be produced, and quality standards of each product type.

2. The application for re-issuance of Certificate of eligibility for cosmetic manufacturing shall consist of the following documents:

a) The application form for re-issuance of Certificate of eligibility for cosmetic manufacturing using Form No. 03 in the Annex enclosed with this Decree;

b) The original of Certificate of eligibility for cosmetic manufacturing (if any).

3. The said documents must be fan-stamped by the cosmetic manufacturer and make up 01 set of the application dossier for issuance/re-issuance of Certificate of eligibility for cosmetic manufacturing.

Article 8. Receipt of application for issuance/re-issuance of Certificate of eligibility for cosmetic manufacturing

1. The application shall be, by hand or by post, submitted to Department of Health where the cosmetic manufacturer’s workshop is located.

2. Within 02 working days from the receipt of the application for issuance/re-issuance of Certificate of eligibility for cosmetic manufacturing, Department of Health shall check the application and perform one of the following acts:

a) Issue a Receipt note according to the Form No. 05 in the Annex enclosed with this Decree if the application is sufficient and valid as referred to in Article 7 herein;

b) Make a written notice of insufficient or invalid contents.

Article 9. Procedures for issuance of Certificate of eligibility for cosmetic manufacturing

1. Before carrying out its operation, the cosmetic manufacturer must submit the application for issuance of Certificate of eligibility for cosmetic manufacturing to Department of Health.

2. Within 30 working days from the receipt of the valid application and appraisal fees as regulated, Department of Health shall inspect the cosmetic manufacturer and issue Certificate of eligibility for cosmetic manufacturing to that cosmetic manufacturer. In case the application is rejected or there are rectifications to be made by the applicant, Department of Health shall give a written notice to specify reasons thereof or a written request for change or remedy.

3. In cases where the cosmetic manufacturer is requested to make certain rectifications:

a) The cosmetic manufacturer must make rectifications and send rectification report to Department of Health;

b) 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;

c) 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.

4. With regard to cosmetic manufacturers that have “Cosmetic Good Manufacturing Practices (CGMP-ASEAN)” Certificates granted by Ministry of Health:   

a) Ministry of Health shall send official dispatches to Departments of Health where workshops of such cosmetic manufacturers are located with respect to the issuance of Certificates of eligibility for cosmetic manufacturing;

b) Within 05 working days from the receipt of the official dispatch sent by Ministry of Health, Departments of Health shall issue Certificates of eligibility for cosmetic manufacturing to such cosmetic manufacturers.

Article 10. Procedures for re-issuance of Certificate of eligibility for cosmetic manufacturing

Within 05 working days from the date on which Department of Health receives the application for re-issuance submitted by the relevant cosmetic manufacturer, Department of Health shall re-issue Certificate of eligibility for cosmetic manufacturing using Form No. 01 in the Annex enclosed with this Decree.

Article 11. Amendment of Certificate of eligibility for cosmetic manufacturing

1. The cosmetic manufacturer that has a Certificate of eligibility for cosmetic manufacturing issued but has change of its name or address due to change of administrative division (the production location is unchanged) shall apply for the amendment of Certificate of eligibility for cosmetic manufacturing.

2. The cosmetic manufacturer shall apply 01 set of the application for amendment of Certificate of eligibility for cosmetic manufacturing, including the following documents:

a) The application form for amendment of Certificate of eligibility for cosmetic manufacturing using Form No. 04 in the Annex enclosed with this Decree;

b) Documents proving changes.

3. The application for amendment of Certificate of eligibility for cosmetic manufacturing shall be received and handled in compliance with regulations in Article 8 of this Decree.

4. Within 05 working days from the date on which Department of Health receives the application for amendment submitted by the relevant cosmetic manufacturer, Department of Health shall issue Certificate of eligibility for cosmetic manufacturing using Form No. 01 in the Annex enclosed with this Decree, in which, the certificate number shall be the same with that of initially issued certificate and the time of amendment, date and reasons of amendment shall be specified.

Article 12. Revocation of Certificate of eligibility for cosmetic manufacturing

Certificates of eligibility for cosmetic manufacturing shall be revoked by the issuing authorities in the following cases:

1. A cosmetic manufacturer fails to meet all of conditions set forth in Article 4 of this Decree;

2. A Certificate of eligibility for cosmetic manufacturing has been issued by an incompetent authority or includes unlawful contents;

3. A cosmetic manufacturer runs its operations at a location other than that stated in the issued Certificate of eligibility for cosmetic manufacturing;

4. The application for issuance/re-issuance/amendment of Certificate of eligibility for cosmetic manufacturing has been forged;

5. A cosmetic manufacturer voluntarily applies for the revocation of Certificate of eligibility for cosmetic manufacturing.

Article 13. Fees for appraising standards and conditions for cosmetic manufacturing

A cosmetic manufacturer that submits the application for issuance of Certificate of eligibility for cosmetic manufacturing must pay fees for appraising standards and conditions for cosmetic manufacturing in accordance with regulations and laws on fees and charges.

Chaprter IV

IMPLEMENTATION

Article 14. Effect

This Decree takes effect as of July 01, 2016.

Article 15. 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.

Article 16. Implementation organization

1. Minister of Health shall be responsible for organizing and guiding the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies, heads of affiliates of the Government and chairpersons of people’s committees of central-affiliated cities or provinces shall be responsible for implementing this Decree./.

ANNEX

(Enclosed to the Government’s Decree No. 93/2016/ND-CP dated July 01, 2016)

Form No. 01

CERTIFICATE OF ELIGIBILITY FOR COSMETIC MANUFACTURING
(*)

Initial certificate is issued on………………………..[date]

Time of amendment:…….., made on………., reasons of amendment:……………..

- Pursuant to the Government’s Decree No………………. providing for conditions for manufacture of cosmetic products;

- Pursuant to……………….defining functions and tasks of……………..

- At the request of ……………..

(NAME OF ISSUING AUTHORITY) HEREBY CERTIFIES

(**) …………………………………………………………………………………………….

Address: ……………………………………………………………………………………..

Has satisfied all conditions for manufacture of cosmetic products

Production lines consist of:………… (***)

(*) In case of re-issuance, the phrase “BẢN CẤP LẠI” (RE-ISSUANCE) must be specified.

(**) Name of cosmetic manufacturer which is stated in the application for issuance of Certificate of eligibility for cosmetic manufacturing is specified.

(***) All production lines are specified, consisting of: Product packaging line; production line for producing semi-finished products in dry; production line for producing semi-finished products in wet form; production line for producing finished products in dry or wet or other form.

Form No. 02

APPLICATION FORM FOR ISSUANCE OF CERTIFICATE OF ELIGIBILITY FOR COSMETIC MANUFACTURING

To: ……………..

Name of cosmetic manufacturer:

Address:

Number of business registration certificate, issued date and issuing authority:

Phone number:                         Fax:                                    E-mail:

Pursuant to the Government’s Decree No……………………dated…………………..providing for conditions for manufacture of cosmetic products, the cosmetic manufacturer…………….does request Department of Health…………to issue Certificate of eligibility for cosmetic manufacturing (production lines consist of:…… (*)), this application includes the following documents:

1. The site plans and design drawings of factory;

2. The list of existing equipment in the factory;

3. The list of cosmetic products which are producing and/or will be produced; quality standards of each type of cosmetic products.

The cosmetic manufacturer…………commits that all contents stated herein are true and authentic, and this cosmetic manufacturer shall bear responsibility for declared contents.

(*) Names of production lines must be specified, consisting of: Product packaging line; production line for producing semi-finished products in dry form;  production line for producing semi-finished products in wet form; production line for producing finished products in dry or wet or other form.

Form No. 03

APPLICATION FORM FOR RE-ISSUANCE OF CERTIFICATE OF ELIGIBILITY FOR COSMETIC MANUFACTURING

To: ……………..

Name of cosmetic manufacturer:

Address:

Number of business registration certificate, issued date and issuing authority:

Phone number:                         Fax:                                    E-mail:

Pursuant to the Government’s Decree No…………………dated………………..providing for conditions for manufacture of cosmetic products, the cosmetic manufacturer…………….does request Department of Health…………to re-issue Certificate of eligibility for cosmetic manufacturing on the basis of the issued Certificate of eligibility for cosmetic manufacturing No......., issued on...........[date]

Reason for re-issuance: ……… (*)

The cosmetic manufacturer…………commits that all contents stated herein are true and authentic, and this cosmetic manufacturer shall bear responsibility for declared contents.

(*) Reasons for re-issuance must be specified as: Loss or damage.

Form No. 04

APPLICATION FORM FOR AMENDMENT OF CERTIFICATE OF ELIGIBILITY FOR COSMETIC MANUFACTURING

To: ……………..

Name of cosmetic manufacturer:

Address:

Number of business registration certificate, issued date and issuing authority:

Phone number:                         Fax:                                    E-mail:

Pursuant to the Government’s Decree No…………………dated………………..providing for conditions for manufacture of cosmetic products, the cosmetic manufacturer…………….does request Department of Health…………to amend the Certificate of eligibility for cosmetic manufacturing on the basis of the Certificate of eligibility for cosmetic manufacturing No......., issued by Department of Health on...........[date]

Reasons for amendment: …..…… (*)

The cosmetic manufacturer…………commits that all contents stated herein are true and authentic, and this cosmetic manufacturer shall bear responsibility for declared contents.

(*) Reasons for amendment must be specified: Change of cosmetic manufacturer’s name or address due to change of administrative division.

Form No. 05

APPLICATION RECEIPT NOTE

Full name of receiver:

Position, working unit:

Has received the application (*)……..submitted by the cosmetic manufacturer:…….

The application consists of the following documents:

1...

2...

3...

(*) The application for issuance, or re-issuance, or amendment of Certificate of eligibility for cosmetic manufacturing must be specified.