Vietnam Amends Circular 06/2011/TT-BYT Providing Cosmetic Management

Article 4

The cosmetic notification dossier includes the following documents

The cosmetic notification dossier, whether submitted online, directly, or through public postal services, includes the following documents

Clause 1, Article 4

Cosmetic Product Notification Form (two copies) and its electronic version

• For online submission via the National Public Service Portal or the Ministry/Provincial Public Service Portal, one copy of the notification form is required.

• For direct or public postal submission, two copies of the notification form are required.

Clause 1, Article 5

The Cosmetic Product Notification Form shall be completed according to the template provided in Appendix 01-MP. The notification report shall be signed by the legal representative and bear the official seal of the organization or individual responsible for bringing the product to market.

The guidelines for completing the contents of the notification form are provided in Appendix 02-MP.

• For online submission via the National Public Service Portal or the Ministry/Provincial Public Service Portal, the notification form must be digitally signed by the legal representative and bear the seal of the organization or individual responsible for bringing the product to market. The use of digital signatures shall comply with the provisions of Decree No. 130/2018/ND-CP Detailed Regulations on the Implementation of the Law on Electronic Transactions Regarding Digital Signatures and Digital Signature Certification Services

• For direct submission or postal submission, the notification form must be signed by the legal representative and bear the seal of the organization or individual responsible for bringing the product to market.

Clause 2, Article 5

The organization or individual declaring the product shall bear responsibility for the consistency of contents in the notification dossier (signed and sealed) with the data and information declared or submitted to the regulatory authority.

The organization or individual declaring the product shall bear the responsibility for the accuracy, legality, and truthfulness of all documents in the cosmetic notification dossier, as well as the consistency of contents in the notification dossier (signed and sealed) with the data and information declared or submitted to the regulatory authority.

Clause 1, Article 7

The cosmetic notification dossier shall be prepared in one set and submitted directly or via public postal services to the competent state management authority as follows

The cosmetic notification dossier shall be prepared in one set, which can be submitted online via the National Public Service Portal or the Ministry/Provincial Public Service Portal, or submitted directly or via public postal services to the competent state management authority as follows

a, Clause 2, Article 35

Organizations or individuals importing cosmetics for research or testing shall submit an Import Order for Cosmetics Used for Research and Testing (as per Appendix 14-MP) to the Drug Administration of Vietnam - Ministry of Health. The maximum quantity allowable for each product is 10 samples.

Appendix 14-MP shall be prepared in three copies. Upon approval, two copies will be kept at the DAV, and one copy will be returned to the organization. The copy sent to the organization shall bear the stamp “Copy for Enterprise” and shall be presented to the Customs authority when processing customs procedures.

Imported cosmetics for research or testing shall be used for the intended purpose and are not allowed to be circulated onto the market.

Organizations or individuals importing cosmetics for research or testing shall submit Appendix 14-MP to the Department of Health where the organization’s headquarters is located. The maximum allowable quantity for each product is 10 samples, based on the smallest commercial packaging unit. A product can be imported once per year.

• For online submission via the Provincial Public Service Portal, one copy of Appendix 14-MP is required.

• For direct submission or submission via public postal services, Appendix 14-MP shall be prepared in three copies. After approval, two copies will be kept at the Department of Health, and one copy will be returned to the organization. The copy sent to the organization shall bear the stamp “Copy for Enterprise” and shall be presented to the Customs authority when processing customs procedures.