Circular 32/2019/TT-BYT amend Circular No. 06/2011/TT-BYT on cosmetic management

CIRCULAR

Amending and supplementing Clause 4 Article 4 and Appendix No. 01-MP of the Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Minister of Health, providing cosmetic management

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Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Government’s Decree No. 69/2018/ND-CP of May 15, 2018, detailing a number of Articles of the Law on Foreign Trade Management;

Implementing the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) dated March 08, 2018;

At proposal of the Director of the Drug Administration Department;

The Minister of Health hereby promulgates the Circular on amending and supplementing Clause 4 Article 4 and Appendix No. 01-MP of the Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Minister of Health, providing cosmetic management.

Article 1. To amend and supplement Clause 4 Article 4 of the Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Minister of Health, providing cosmetic management (hereinafter referred to as Circular No. 06/2011/TT-BYT)

To amend and supplement Clause 4 Article 4 of the Circular No. 06/2011/TT-BYT as follows:

“4. The Certificate of Free Sale (CFS):

a) In case of proclamation of imported cosmetic product from countries other than CPTPP members, the CFS shall meet the following requirements:

- CFS which is issued by the exported country must have been original and still in the date of validity. In case CFS is not provided of the expiry date, it must be a certificate which has just been issued within 24 months.

- CFS must be consul legalized according to provisions of the law, except consul legalization immunity case according to the international treaties in which Vietnam is a member.

- CFS must contain at least information prescribed in Article 36 of the Law on Foreign Trade Management and Clause 3 Article 10 of the Government’s Decree No. 69/2018/ND-CP dated May 15, 2018, detailing a number of Articles of the Law on Foreign Trade Management.

b) In case of proclamation of cosmetic product which is circulated and exported from CPTPP members (CPTPP member means any State or separate customs territory in which the CPTTP is approved and effective), CFS is not required.”

Article 2. To amend and supplement Appendix No. 01-MP attached to the Circular No. 06/2011/TT-BYT

To amend and supplement Appendix No. 01-MP attached to the Circular No. 06/2011/TT-BYT according to the Appendix attached to this Circular.

Article 3. Transitional provisions

a) The proclamation dossier of imported cosmetic from CPTPP members which is submitted from the effective date in Vietnam of the CPTPP (January 14, 2019) shall comply with this Circular.

b) The cosmetic proclamation dossier attached form in the Appendix No. 01-MP of the Circular No. 06/2011/TT-BYT which is submitted before the effective date of this Circular shall comply with the Circular No. 06/2011/TT-BYT, except cases requesting to implementation according to this Circular.

Article 4. Effect

This Circular takes effect on February 01, 2020.

Article 5. Implementation responsibility

1. The Director of the Drug Administration Department shall take responsibility for implementation and organization of this Circular.

2. The Chief of the Ministry Office, Chief of Inspector of Ministry, Heads of units under and directly under the Ministry of Health; director of Provincial and Central Cities department of Health, and related organizations or individuals are obligated to fulfill implement this Circular.

Any problem arising in the course of implementation of this Circular should be reported to the Ministry of Health (Department of Drug Administration - The Ministry of Health, address: 138A Giang Vo, Ba Dinh District, Hanoi) for consideration and settlement./.

For the Minister

The Deputy Minister

Truong Quoc Cuong

APPENDIX

COSMETIC PRODUCT PROCLAMATION FORM

Appendix No. 01-MP

TEMPLATE FOR NOTIFICATION OF COSMETIC PRODUCT

þ Tick, where applicable

PARTICULARS OF PRODUCT

1. Name of brand & product:

1.1. Brand

1.2. Product Name

1.3. List of Variants or Shade. Names

2. Product type(s)

* Creams, emulsions, lotions, gels and oils for skin (hands, face, feet, etc)

* Face masks (with the exception of chemical peeling products)

* Tinted bases (liquids, pastes, powders)

* Make-up powders, after-bath powder, hygienic powders, etc.

* Toilet soaps, deodorant soaps, etc.

* Perfumes, toilet waters and eau de Cologne, etc.

* Bath or shower preparations (salts, foams, oils, gels, etc)

* Depilatories

* Deodorants and anti-perspirants

* Hair care products

-  Hair tints and bleaches

-  Products for waving, straightening and fixing

-  Setting products

- Cleansing products (lotions, powders, shampoos)

- Conditioning products (lotions, creams, oils)

-  Hairdressing products (lotions, lacquers, brilliantines)

* Shaving product (creams, foams, lotions, etc)

* Products for making-up and removing make-up from the face and the eyes

* Products intended for application to the lips

* Products for care of the teeth and the mouth

* Products for nail care and make-up

* Products for external intimate hygiene

* Sunbathing products

* Products for tanning without sun

* Skin whitening products

* Anti-wrinkle products

* Others (please specify)

3. Intended use

4. Product presentation(s)

* Single product

* A range of colours

* Palette(s) in a range of one product type

* Combination products in a single kit

* Others (please specify)

PARTICULARS OF MANUFACTURER(S)/ASSEMBLER(S)/EXPORTER

(Please attach in a separate sheet if there are more than one manufacturer/assembler)

5. Name of manufacturer:

Address of manufacturer (state country)):

6. Name of assembler (Please tick accordingly. May tick more than one box)):

□ Primary assembler                 □ Secondary assembler

(Address of assembler (state country):

7. Name of exporter (Please tick accordingly. Only apply to imported cosmetic products):

Cosmetic product(s) are free sold in the exporting country: □ Yes □ No

Address of exporter (state country):

PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC PRODUCT IN THE MARKET

8. Name of company:

Address of company:

Business Registration Number/License to Operate Number

PARTICULARS OF PERSON REPRESENTING THE LOCAL COMPANY

9. Name of person:

Designation in the company:

PARTICULARS OF IMPORTER

10. Name of importer:

Address of importer:

PRODUCT INGREDIENT LIST

11. Please check the following boxes:

* I have examined the latest revisions of the Annexes II to VII of the ASEAN Cosmetic Ingredient Listing as published in the latest amendment of the ASEAN Cosmetic Directive and confirmed that the product in this notification does not contain any prohibited substances and is in compliance with the restrictions and conditions stipulated in the Annexes.

* I undertake to respond to and cooperate fully with the regulatory authority with regard to any subsequent post-marketing activity initiated by the authority.

Product full ingredient list

(To submit ingredient list with percentages of restricted ingredients)

DECLARATION

1. I hereby declare on behalf of my company that the product in the notification meets all the requirements of the ASEAN Cosmetic Directive, its Annexes and Appendices.

2. I undertake to abide by the following conditions:

i. Ensure that the product’s technical and safety information is made readily available to the regulatory authority concerned (“the Authority”) and to keep records of the distribution of the products for product recall purposes;

ii. Notify the Authority of fatal or life threatening serious adverse event¹ as soon as possible by telephone, facsimile transmission, email or in writing, and in any case, no later than 7 calendar days after first knowledge;

iii. Complete the Adverse Cosmetic Event Report Form² within 8 calendar days from the date of my notification to the Authority in para 2 ii. above, and to provide any other information as may be requested by the Authority;

iv. Report to the Authority of all other serious adverse events that are not fatal or life threatening as soon as possible, and in any case, no later than 15 calendar days after first knowledge, using the Adverse Cosmetic Event Report Form;

v. Notify the Authority of any change in the particulars submitted in this notification;

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¹ As defined in the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products.

² Set out in Appendix I to the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products.

3. I declare that the particulars given in this notification are true, all data, and information of relevance in relation to the notification have been supplied and that the documents enclosed are authentic or true copies.

4. I understand that I shall be responsible for ensuring that each consignment of my product continues to meet all the legal requirements, and conforms to all the standards and specifications of the product that I have declared to the Authority.

5. I understand that I cannot place reliance on the acceptance of my product notification by the authority in any legal proceedings concerning my product, in the event that my product has failed to conform to any of the standards or specifications that I had previously declared to the Authority.

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Name and Signature of person representing the local company