Legal Counselling

Vietnam: Establishments producing veterinary drugs containing narcotics must have a certificate issued by the Department of Animal Health

16:30, 02/12/2020

On November 09, 2020, the Ministry of Agriculture and Rural Development of Vietnam issued the Circular No. 12/2020/TT-BNNPTNT providing for management of veterinary drugs containing narcotic substances and precursors; veterinary prescribing; amendments to the Circular No. 18/2018/TT-BNNPTNT.

Cơ sở sản xuất thuốc thú y, Thông tư 12/2020/TT-BNNPTNT

According to Article 7 of Circular No. 12/2020/TT-BNNPTNT of the Ministry of Agriculture and Rural Development of Vietnam, domestic production of substance- and precursor-containing veterinary drugs shall be only carried out by producers having an effective certificate of eligibility to produce veterinary drugs issued by the Department of Animal Health. Procedures for registering sale of substance- and precursor-containing veterinary drugs are specified Articles 3 and 8 of the Decree No. 13/2016/TT-BNNPTNT.

Note: The manufacturer shall physically or electronically archive substance- and precursor-containing veterinary drug production records, including:

- A processing and production logbook, which is prepared using the form in the Appendix V of Circular No. 12/2020/TT-BNNPTNT;

- The documents specified in Points a and b Clause 7 Article 4 of Circular No. 12/2020/TT-BNNPTNT;

- Documents concerning sale of narcotic substance- and precursor-containing veterinary drugs; substance- and precursor-containing veterinary drug materials.

Moreover, Article 6 of Circular No. 12/2020/TT-BNNPTNT also stipulates that applications and procedures for licensing transit of substance- and precursor-containing veterinary drugs and veterinary drug materials through Vietnam are specified in Articles 12 and 13 of the Decree No. 58/2003/ND-CP of Vietnam’s Government.

View more details at the Circular No. 12/2020/TT-BNNPTNT of the Ministry of Agriculture and Rural Development of Vietnam, effective from December 25, 2020.

Le Vy

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