Time limit for testing herbal ingredients and traditional drugs

Time limit for testing herbal ingredients and traditional drugs
Bảo Ngọc

The Ministry of Health promulgates Circular 38/2021/TT-BYT dated December 31, 2021 regulating the quality of herbal ingredients, traditional medicines and traditional medicines.

Accordingly, the time limit for testing herbal ingredients and traditional drugs of the same type as those in violation of quality shall be counted from the time when the first batch of herbal ingredients and traditional drugs is imported or manufactured after the expiry date. The point of the Ministry of Health announcing the list of business establishments having herbal ingredients and traditional drugs with violations of quality is as follows:

- For medicinal herbs:

+ 06 months for establishments having 01 batch of herbal ingredients with level 2 violations;

+ 12 months for establishments having 01 batch of herbal ingredients in violation of level 1 or having 02 batches of herbal ingredients with level 2 violations or more.

(Currently stipulating the above time limit for establishments whose batches of infringing medicinal ingredients are recalled and are allowed to be remedied and reused)

- For traditional medicine:

+ 06 months for establishments having 01 batch of traditional drugs with level 3 violations;

+ 12 months for establishments that have 01 batch of traditional drugs in violation of level 2 or have 02 batches of traditional drugs with level 3 violations or more;

+ 24 months for establishments that have 01 batch of traditional drugs with level 1 violations or have 02 or more batches of traditional drugs with level 2 violations or more.

Circular 38/2021/TT-BYT takes effect from February 15, 2022 and replaces Circular 13/2018/TT-BYT .

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE


1 lượt xem
  • Address: 19 Nguyen Gia Thieu, Vo Thi Sau Ward, District 3, Ho Chi Minh City
    Phone: (028) 7302 2286
    E-mail: info@lawnet.vn
Parent company: THU VIEN PHAP LUAT Ltd.
Editorial Director: Mr. Bui Tuong Vu - Tel. 028 3935 2079
P.702A , Centre Point, 106 Nguyen Van Troi, Ward 8, Phu Nhuan District, HCM City;