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

DECREE

Prescribing conditions for cosmetic production[1]

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

Pursuant to the November 26, 2014 Investment Law;

At the proposal of the Minister of Health;

The Government promulgates the Decree prescribing conditions for cosmetic production.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

This Decree prescribes conditions on establishments producing semi-finished and finished cosmetic products and establishments packaging cosmetics (below referred to as cosmetic production establishments); and the order and procedures for grant, re-grant, modification and revocation of certificates of eligibility for cosmetic production.

Article 2. Interpretation of terms

In this Decree, the following terms are construed as follows:

1. Cosmetic product means a substance or preparation which is used in contact with external human body parts (skin, hair, fingernails, toenails, lips and external genital organs), teeth or oral mucosa in order to obtain one or several of the following main purposes: cleansing, aromatizing, changing the countenance and appearance, adjusting body odor and keeping the body in good conditions.

2. Semi-finished cosmetic product means a product which has not yet been completely processed and needs to further undergo one or more than one production or packaging phase before turning into a finished one.

Chapter II

CONDITIONS FOR COSMETIC PRODUCTION

Article 3. Conditions for operation of cosmetic production establishments

1. Being lawfully established.

2. Having a certificate of eligibility for cosmetic production, made according to Form No. 01 in the Appendix to this Decree.

Article 4. Conditions for grant of certificates of eligibility for cosmetic production

A cosmetic production establishment must meet the following conditions:

1. Staff: The person in charge of production activities must possess professional knowledge in one of the following majors: chemistry, biology, pharmacology or other relevant majors which enable him/her to meet work requirements.

2. Physical foundations:

a/ The location and area of the production workshop as well as production equipment and devices must meet the requirements on production lines for the types of cosmetic products which the establishment intends to produce as stated in the dossier of application for a certificate of eligibility for production of cosmetic products;

b/ Warehouses for storing raw materials, packaging materials and finished products must ensure separate storage of raw materials, packaging materials and finished products;  and have separate areas for storing flammable and explosive substances, highly toxic substances, and discarded, recalled and returned materials, supplies and products.

3. Having a quality control system meeting the following requirements:

a/ Materials and auxiliary materials used in cosmetic production must meet the quality criteria set by their manufacturers;

b/ Water used in cosmetic production must at least meet the national technical regulation on drinking water promulgated by the Minister of Health;

c/ Semi-finished products used in production must be those for which their manufacturers have established quality standards and which must meet such quality standards;

d/ Having worked out a production process for each product;

dd/ Having a quality control section to inspect the quality of materials, semi-finished products, products awaiting packaging, and finished products;

e/ Having a dossier-archiving system.

Chapter III

COMPETENCE, DOSSIERS AND PROCEDURES FOR GRANT OF CERTIFICATES OF ELIGIBILITY FOR COSMETIC PRODUCTION

Article 5. Competence to grant certificates of eligibility for cosmetic production

Provincial-level Health Departments shall grant certificates of eligibility for cosmetic production to cosmetic production establishments located in their localities.

Article 6. Forms of grant of certificates of eligibility for cosmetics production

1. A certificate of eligibility for cosmetics production may be granted  to:

a/ A production establishment which applies for a certificate of eligibility for cosmetic production;

b/ A production establishment which has been granted a certificate of eligibility for cosmetic production but now relocates its production plant;

c/ A production establishment which has been granted a certificate of eligibility for cosmetic production but now installs a new production line in addition to those for which it has been granted such certificate.

2. A certificate of eligibility for cosmetic production may be re-granted in case of loss or damage of a granted certificate.

Article 7. Dossiers of application for grant or re-grant of certificates of eligibility for cosmetic production

1. A dossier of application for grant of a certificate of eligibility for cosmetic production must comprise:

a/ An application for a certificate of eligibility for cosmetic production, made according to Form No. 2 in the Appendix to this Decree;

b/ The production establishment’s ground plan and design plan;

c/ A list of existing equipment of the production establishment;

d/ A list of commodity items the production establishment is producing or intends to produce and quality standards applicable to each commodity item.

2. A dossier of application for re-grant of a certificate of eligibility for cosmetic production must comprise:

a/ An application for re-grant of a certificate of eligibility for cosmetic production, made according to Form No. 03 in the Appendix to this Decree;

b/ The original certificate of eligibility for cosmetic production (if available).

3. A dossier of application for grant or re-grant of a certificate of eligibility for cosmetic production shall be made in 1 set with documents fan-stamped by the applying production establishment.

Article 8. Receipt of dossiers of application for grant or re-grant of certificates of eligibility for cosmetic production

1. A dossier may be submitted directly or sent by post to the provincial-level Health Department of the locality where the applying production establishment’s plant is located.

2. Within 2 working days after receiving a dossier of application for grant or re-grant of a certificate of eligibility for cosmetic production, the provincial-level Health Department shall check the dossier and proceed with one of the following actions:

a/ To grant a dossier receipt, made according to Form No. 05 in the Appendix to this Decree, if the dossier is complete and valid as prescribed in Article 7 of this Decree;

b/ To notify in writing the applicant of incomplete or invalid contents.

Article 9. Order of grant of certificates of eligibility for cosmetic production

1. Before conducting production activities, a production establishment shall submit a dossier of application for grant of a certificate of eligibility for cosmetic production to the provincial-level Health Department.

2. Within 30 days after receiving a valid dossier and an appraisal charge as prescribed, the provincial-level Health Department shall inspect the production establishment and grant a certificate of eligibility for cosmetic production; in case the provincial-level Health Department refuses to grant a certificate or requests the establishment to make changes or improvements, it shall issue a written notice clearly stating the reason.

3. In case the production establishment is required to make changes or improvements:

a/ The production establishment shall immediately make changes or improvements and send a report thereon to the provincial-level Health Department;

b/ The provincial-level Health Department shall consider the report and conduct documentary examination or re-inspect the production establishment (when necessary). Within 15 days after receiving a report on changes or improvements that have been made, the inspection agency shall give a written reply on the examination or inspection result;

c/ Within 6 months after issuing a written request for the production establishment to make changes or improvements, if the provincial-level Health Department receives no report from the establishment, the establishment’s dossier of application for grant of a certificate of eligibility for cosmetics production will become invalid.

4. For an establishment which  has been granted a cosmetic good manufacturing practices (CGMP-ASEAN) certificate:

a/ The Ministry of Health shall send a document on the grant of a certificate of eligibility for cosmetic production to the provincial-level Health Department of the locality where the establishment’s cosmetic plant is located;

b/ Within 5 working days after receiving the Ministry of Health’s document, the provincial-level Health Department shall grant a certificate of eligibility for cosmetic production to the establishment.

Article 10. Order of re-grant of certificates of eligibility for cosmetic production 

Within 5 working days after receiving an application from a cosmetic production establishment, the provincial-level Health Department shall re-grant a certificate of eligibility for cosmetic production  to the establishment, made according to Form No. 01 in the Appendix to this Decree.

Article 11. Modification of certificates of eligibility for cosmetic production

1. In case a production establishment which has been granted a certificate of eligibility for cosmetic production changes its name or address due to adjustment of administrative boundary (without changing its production location), its certificate of eligibility for cosmetic production shall be modified.

2. A dossier of application for modification of a certificate of eligibility for cosmetic production shall be made in 1 set comprising the following documents:

a/ An application for modification of a certificate of eligibility for cosmetic production, made according to Form 04 in the Appendix to this Decree;

b/ Papers proving the change.

3. The receipt of a dossier of application for modification of a certificate of eligibility for cosmetic production must comply with Article 8 of this Decree.

4. Within 5 working days after receiving an application from a cosmetic production establishment, the provincial-level Health Department shall grant a certificate of eligibility for cosmetic production, which shall be made according to Form No. 01 in the Appendix to this Decree bearing the serial number of the original certificate and specifying the time, date and reason of modification.

Article 12. Revocation of certificates of eligibility for cosmetic production

An agency which has granted a certificate of eligibility for cosmetic production shall revoke the certificate in one of the following cases:

1. The certificate holder fails to meet the conditions prescribed in Article 4 of this Decree.

2. The certificate is granted ultra vires or contains illegal contents.

3. The certificate holder produces cosmetics outside the location specified in the certificate.

4. The certificate holder has falsified documents in the dossier for grant, re-grant or modification of the certificate.

5. The certificate holder requests in writing the revocation of its certificate.

Article 13. Charge for appraisal of conditions for cosmetic production

Cosmetic production establishments that submit dossiers of application for grant of certificates of eligibility for cosmetic production shall pay a charge for appraisal of standards and conditions for cosmetic production in accordance with the law on charges and fees.

Chapter IV     

IMPLEMENTATION PROVISIONS

Article 14. Effect

This Decree takes effect on July 1, 2016.

Article 15. Transitional provisions

1. Production establishments that have been operating before this Decree takes effect may continue producing the types of cosmetics whose cosmetic product notification acknowledgment letters remain valid but shall complete the procedures to apply for a certificate of eligibility for cosmetic production as prescribed in this Decree before December 31, 2018.

2. In case a production establishment that has been operating before this Decree takes effect wishes to additionally produce cosmetic products of a type other than those for which cosmetic product notification acknowledgment letters have been issued, before starting producing new cosmetic products, it shall carry out the procedures to apply for a certificate of eligibility for cosmetic production as prescribed in this Decree.

3. The Ministry of Health shall notify provincial-level Health Departments of the list of cosmetic production establishments which have been granted cosmetic good manufacturing practices (CGMP-ASEAN) certificates by the Ministry of Health before this Decree takes effect for the latter to grant certificates of eligibility for cosmetic production to such establishments before December 31, 2016.

4. In the course of operation, cosmetic production establishments shall apply the quality control systems according to CGMP-ASEAN principles and standards.

Article 16. Organization of implementation

1. The Minister of Health shall organize and guide the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies, heads of government-attached agencies and chairpersons of provincial-level People’s Committees shall implement this Decree.

On behalf of the Government
Prime Minister
NGUYEN XUAN PHUC

* The Appendix to this Decree is not translated.