Vietnam: Requirements for management of quality of herbal ingredients and traditional drugs during trading and use thereof

According to Circular No. 13/2018/TT-BYT of the Ministry of Health of Vietnam, requirements for management of quality of herbal ingredients and traditional drugs during trading and use thereof are as follows:

- Trading facilities must apply Good Practice standards during the process of trading and using herbal ingredients/ traditional drugs in conformity with their scope of business.

- Herbal ingredients and primary packages of traditional drugs must be tested by the traditional drug manufacturer and meet quality standards before their manufacture is commenced.

- Finished traditional drugs/ herbal ingredients must be tested by their manufacturers and meet quality standards before being released.

- The head and the chief pharmacist of the manufacturer, exporter, importer, wholesaler or retailer; the person in charge of quality assurance of the manufacturer shall be responsible for the management and inspection of the quality of its herbal ingredients/ traditional drugs.

- Establishments trading in herbal ingredients/ traditional drugs shall inspect and control the quality of their herbal ingredients, traditional drugs and ingredients of traditional drugs.

- Manufacturers shall test and assess the quality of their herbal ingredients, traditional drugs and ingredients of traditional drugs during the process of manufacture, release and sale.

- Establishments trading in herbal ingredients/ traditional drugs must keep all documents concerning every trading, import, release or distribution of herbal ingredients/ traditional drugs for the purposes of monitoring origins, transport and storage conditions of such herbal ingredients/ traditional drugs and ingredients of traditional drugs.

- Manufacturers and trading facilities shall also comply with other regulations of the Law on pharmacy so as to ensure the quality of herbal ingredients/ traditional drugs during trading and use thereof.

Circular No. 13/2018/TT-BYT of the Ministry of Health of Vietnam takes effect from June 30, 2018.

- Thanh Lam -

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE