DECISION

CORRECTIONS TO CIRCULAR NO. 39/2021/TT-BYT DATED DECEMBER 31, 2021 OF THE MINISTER OF HEALTH OF VIETNAM ON AMENDMENTS TO CIRCULAR NO. 21/2018/TT-BYT DATED SEPTEMBER 12, 2018 OF THE MINISTER OF HEALTH OF VIETNAM ON REGISTRATION FOR CIRCULATION OF TRADITIONAL MEDICINES AND DRUGS

THE MINISTER OF HEALTH OF VIETNAM

Pursuant to the Law on Promulgation of Legislative Documents of Vietnam dated June 22, 2015;

Pursuant to Decree No. 34/2016/ND-CP dated May 14, 2016 of the Government of Vietnam elaborating the Law on Promulgation of Legislative Documents and its implementation measures;

Pursuant to Decree No. 154/2020/ND-CP dated December 31, 2020 of the Government of Vietnam on Amendments to Decree No. 34/2016/ND-CP dated May 14, 2016 of the Government of Vietnam elaborating the Law on Promulgation of Legislative Documents and its implementation measures;

Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government of Vietnam on functions, tasks, entitlements, and organizational structure of the Ministry of Health of Vietnam;

At the request of the Director of the Traditional Medicine Administration,

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Article 1. Corrections to Circular No. 39/2021/TT-BYT dated December 31, 2021 of the Minister of Health of Vietnam on Amendments to Circular No. 21/2018/TT-BYT dated September 21, 2018 of the Minister of Health of Vietnam on registration for circulation of traditional medicines and drugs:

1. In Clause 7 of Article 1: replace the phrase “Hệ thống chứng nhận chất lượng của các sản phẩm dược lưu hành trong thương mại quốc tế” (System of quality certification of pharmaceutical products circulating in international trade) with “Hệ thống chứng nhận chất lượng của các sản phẩm được lưu hành trong thương mại quốc tế” (System of quality certification of products eligible for circulating in international trade).

2. In Clause 10 of Article 1: replace the phrase “do Bộ chủ quản ngành xét duyệt theo quy hiện hành” with “do Bộ chủ quản ngành xét duyệt theo quy định hiện hành” (approved by the Governing Ministry of the Industry according to current regulations).

3. In Clause 29 of Article 1: replace the phrase “trừ trường có yêu cầu khác của Cục Quản lý Y, dược cổ truyền” with “trừ trường hợp có yêu cầu khác của Cục Quản lý Y, dược cổ truyền” (except for cases with other requests of the Traditional Medicine Administration).

Article 2. This Decision comes into force as of its date of signing.

Article 3. Chief of Ministry Office, Director of the Traditional Medicine Administration, and relevant agencies, organizations, and individuals shall implement this Decision./.

PP. MINISTER
DEPUTY MINISTER




Do Xuan Tuyen

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