Decision No. 7866/QD-BYT dated December 28, 2018 of the Ministry of Health on announcing the administrative procedures, which have just been issued amended and supplemented in cosmetics under the management of the Ministry of Health

No.

Name of administrative procedure

Field

Authority in charge

A1. Administrative procedures of central authorities

1

Issuance of receipt number of the notification of cosmetic product

Cosmetics

Drug Administration of Vietnam

2

Issuance of Cosmetics Good Manufacturing Practice (CGMP-ASEAN) Certificate (hereinafter referred to as "the ASEAN CGMP Certificate")

Cosmetics

Drug Administration of Vietnam

3

Approval for order for purchase of imported cosmetics for research and testing purposes

Cosmetics

Drug Administration of Vietnam

A2. Administrative procedures of provincial authorities

4

Issuance of receipt number of the notification of domestically manufactured cosmetic product

Cosmetics

Department of Health

No.

Administrative procedure documentation number

Name of existing administrative procedure

Name of legislative document providing for amendments

Field

Authority in charge

B1. Administrative procedures of provincial authorities

1

B-BYT-286777-TT

Issuance of Certificates of eligibility for cosmetic manufacturing

Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to some Articles related to business conditions under state management of the Ministry of Health (hereinafter referred to as the “Decree No. 155/2018/ND-CP”)

Cosmetics

Department of Health

2

B-BYT-286778-TT

Re-issuance of Certificates of eligibility for cosmetic manufacturing

Decree No. 155/2018/ND-CP

Cosmetics

Department of Health

1. Procedure

Issuance of receipt number of the notification of cosmetic product

Sequence

 Step 1:Before import,theorganization or individual responsible for placing the cosmetic product in the market shall submit an application for registration of the cosmetic product declaration to the Drug Administration of Vietnam National through the National Single-window Information Portal (athttp://vnsw.gov.vn).

Step 2:Within 01 working day from the receipt of the application, the Drug Administration of Vietnam shall examine it and issue a fee notice if the application is satisfactory.  If the application is not satisfactory, issue a notice and specify necessary additional documents therein.

Step 3:Application forthe cosmetic product declaration shall be processed as follows:

a) Within 03 working days from the receipt of the satisfactory application and application fees, the Drug Administration of Vietnam shall issue the receipt number of the notification of cosmetic product.

b) If the application is not satisfactory, within 05 working days from the receipt of the application, the Drug Administration of Vietnam shall issue an electronic notice and specify necessary additional documents therein.

Additional documents include:

- A written representation of amendments made by the applicant;

- A notification of cosmetic product and/or other documents to which amendments are made;

Within 05 working days from the receipt of the additional documents, the Drug Administration of Vietnam shall issue the receipt number of the notification of cosmetic product.

If the additional documents are not satisfactory, within 05 working days from the receipt of the additional documents, the Drug Administration of Vietnam shall issue an electronic notice of failure to issue the receipt number of the notification of cosmetic product.

c) Within 03 months from the date on which the abovementioned electronic notice is issued, if the Drug Administration of Vietnam does not receive any additional document, the application for registration of the cosmetic product declaration will be invalidated. In this case, the applicant that wishes to apply for registration of the cosmetic product declaration shall submit a new application and pay fees/charges as prescribed.

Method of implementation1

To submit an application through the National Single-window Information Portal (at http://vnsw.gov.vn).

Composition  and number of application

a. Composition2:

- A notification of cosmetic product;

- An authorization letter by the manufacturer or product owner that authorizes the organization or individual responsible for placing the cosmetic product in the market to distribute cosmetic products in Vietnam;

- A Certificate of Free Sale (CFS).

b. Number of documents:01 set.

Limit time for processing application

- Within 03 working days from the receipt of the satisfactory application and application fees (if the receipt number has been issued);

- Within 05 working days from the receipt of the application and application fees (if the receipt number has not yet been issued).

Subject for administrative procedures

organization or individual

Agency of handling administrative procedures

Drug Administration of Vietnam.

Result of handling of administrative procedures

Receipt number of the notification of cosmetic product.

Fees (if any)

VND 500,000 (five hundred thousand dong).

Name of template (Issued with this procedure)

Appendix I: Form of the notification of cosmetic product (Appendix No. 01-MP).

Requirements and conditions for following administrative procedures (if any)

- The organization or individual responsible for placing the cosmetic product in the market must be licensed to trade in cosmetics in Vietnam.

- Safety assessment of the cosmetic product shall be made according to ASEAN Guidelines for the Safety Assessment of a Cosmetic Product.

Legal foundation for administrative procedures

- The Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government on amendments to some articles related to business conditions under state management of the Ministry of Health;

- Decision No. 2659/QD-BYT dated June 17, 2016 of the Minister of Health on the application of one-door custom mechanism for the administrative procedures on receiving the publication of imported cosmetics;

- Circular No. 277/2016/TT-BTC dated November 14, 2016 of the Ministry of Finance on amounts, collection, payment, management and use of fees in the fields of pharmacy and cosmetics

- Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Ministry of Health on providing cosmetic management