Legal Counselling

Vietnam: Priority cases in which the time limit for issuing the certificate of traditional drug marketing authorization is likely to be reduced

11:48, 11/10/2018

The Ministry of Health of Vietnam issued Circular No. 21/2018/TT-BYT on marketing authorization of traditional drugs and herbal materials, which is effective from October 28, 2018.

According to Circular No. 21/2018/TT-BYT of the Ministry of Health of Vietnam, the time limit for issuing the certificate of traditional drug marketing authorization is likely to be reduced if:

- The drug serves purposes related to national defense and security, prevention and elimination of epidemics, disaster recovery, or need for special treatment;

- The drug is domestically manufactured on new lines satisfying GMP standards within 12 months from the date in which the GMP certificate is issued.

- The drug is derived from domestic herbal materials satisfying GACP requirements.

Note: Documents and procedures intended for the priority cases shall comply with Article 20 of Circular No. 21/2018/TT-BYT.

Circular No. 21/2018/TT-BYT of the Ministry of Health of Vietnam takes effect from October 28, 2018.

- Thanh Lam -

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