Vietnam: Retention period of origin-related documents

Circular No. 13/2018/TT-BYT on the quality of herbal ingredients and traditional drugs of the Ministry of Health of Vietnam takes effect from June 30, 2018, which has specified quality standards of herbal ingredients and traditional drugs; origins of herbal ingredients and traditional drugs; inspection and handling of inspection results of quality of herbal ingredients and traditional drugs.

According to Circular No. 13/2018/TT-BYT of the Ministry of Health of Vietnam, an establishment trading in herbal ingredients/traditional drugs must fully keep hard copies or soft copies of documents concerning each receipt or supply of herbal ingredients, traditional drugs and traditional drug ingredients with the accurate information about: name of manufacturer or importer of herbal ingredients/traditional drugs; information concerning herbal ingredients/traditional drugs (name, dosage form, concentration or content, batch number, manufacturing date and expiry date, etc.); quantity of herbal ingredients/ traditional drugs received or supplied; date of receipt or supply; etc.

Retention period of origin-related documents is specified as follows:

- Documents concerning the origin of a herbal ingredient or traditional ingredient must be kept for at least 06 months after its expiry date;

- Documents concerning the origin of a traditional drug must be kept for at least 12 months after its expiry date.

View more details about quality standards of herbal ingredients and traditional drugs at the Circular No. 13/2018/TT-BYT of the Ministry of Health of Vietnam.

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