Circular No. 32/2019/TT-BYT amends and supplements Clause 4, Article 4 and Annex No. 01-MP of Circular No. 06/2011/TT-BYT dated January 25, 2011, issued by the Minister of Health, concerning cosmetic management.

CIRCULAR

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

Pursuant to Decree No. 75/2017/NĐ-CP dated June 20, 2017 of the Government stipulating functions, tasks, powers, and organizational structureof ministries and ministerial-level agencies transmission within the scope of payment of the health insurance fund.

Pursuant to Decree No. 69/2018/NĐ-CP dated May 15, 2018 of the Government detailing certain provisions of the Law on Management of Foreign Trade; Implementing the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) signed

on March 8, 2018;At the request of the Director of the Drug Administration Department,this Circular amends and supplements Clause 4, Article 4 and Appendix No. 01-MP of Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Minister of Health on the management of cosmetics. Article 1. Amending and supplementing Clause 4, Article 4 of Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Minister of Health on the management of cosmetics (hereinafter referred to as Circular No. 06/2011/TT-BYT)

Amending and supplementing Clause 4, Article 4 of Circular No. 06/2011/TT-BYT as follows:"4. Free Circulation Certificate (CFS):

THE MINISTER OF HEALTH a) In the case of announcing imported cosmetic products from countries that are not members of the CPTPP, a CFS must meet the following requirements:- The CFS issued by the exporting country must be the original copy, still valid. If the CFS does not specify an expiration date, it must have been issued within 24 months from the date of issuance. - The CFS must be legalized according to the provisions of the law, except in cases where legalization is exempted under international treaties to which Vietnam is a party.

- The CFS must contain at least the information specified in Article 36 of the Law on Management of Foreign Trade and Clause 3, Article 10 of Decree No. 69/2018/NĐ-CP dated May 15, 2018 of the Government detailing certain provisions of the Law on Management of Foreign Trade.

b) In the case of announcing cosmetic products that are circulating and exported from CPTPP member countries (a CPTPP member country is any state or customs territory for which the CPTPP has been ratified and entered into force), a CFS is not required."
Article 2. Amending and supplementing Appendix No. 01-MP promulgated together with Circular No. 06/2011/TT-BYT
Appendix No. 01-MP promulgated together with Circular No. 06/2011/TT-BYT shall be amended and supplemented according to the Appendix promulgated together with this Circular.

a) For the notification dossier of imported cosmetic products from CPTPP member countries submitted from the date the CPTPP enters into force in Vietnam (January 14, 2019), this Circular shall apply.

b) For the notification dossier of cosmetic products accompanied by samples specified in Appendix No. 01-MP of Circular No. 06/2011/TT-BYT submitted before the effective date of this Circular, Circular No. 06/2011/TT-BYT shall apply, except when the entity requests application of this Circular.

This Circular takes effect from February 1, 2020.

1. The Director of the Drug Administration Department is responsible for organizing and implementing this Circular.

2. The Heads of the Ministry's Office, the Inspectorate, the heads of units under and affiliated with the Ministry of Health, the Directors of Provincial Health Services under centrally governed cities and relevant organizations and individuals are responsible for implementing this Circular.

During the implementation of this Circular, if there are any difficulties, the organization or individual concerned shall send their opinions to the Ministry of Health (Drug Administration Department - Ministry of Health, address: 138A Giang Vo, Ba Dinh, Hanoi) for consideration and resolution./.

Article 3. Transitional Provisions

a) The dossier for announcing imported cosmetic products from CPTPP member countries submitted from the date the CPTPP Agreement takes effect in Vietnam (January 14, 2019) shall be implemented in accordance with the provisions of this Circular.

b) The dossier for announcing cosmetic products accompanied by samples specified in Appendix No. 01-MP of Circular No. 06/2011/TT-BYT submitted before the effective date of this Circular shall be implemented in accordance with Circular No. 06/2011/TT-BYT, except where the entity requests implementation in accordance with the provisions of this Circular.

Article 4. Effective date

This Circular takes effect from February 1, 2020.

Article 5. Responsibilities for Implementation

1. The Director of the Drug Administration Department is responsible for organizing and implementing this Circular.

2. The Head of the Ministry's Office, the Inspector General of the Ministry, the Heads of units under and directly under the Ministry of Health, the Directors of Provincial Health Services under central cities, and organizations and individuals related to this matter are responsible for enforcing this Circular.

During the implementation of this Circular, if there are any difficulties, entities and individuals shall submit their opinions to the Ministry of Health (Drug Administration Department - Ministry of Health, address: 138A Giang Vo, Ba Dinh, Hanoi) for consideration and resolution./.