Circular No. 13/2018/TT-BYT dated May 15, 2018 of the Ministry of Health on quality of herbal ingredients and traditional drugs

THE MINISTRY OF HEALTH 

Circular No. 13/2018/TT-BYT dated May 15, 2018 of the Ministry of Health on quality of herbal ingredients and traditional drugs

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and organizational structure of Ministry of Health;

At the request of the Director of the Traditional Medicine Administration of Vietnam;

The Minister of Health promulgates a Circular prescribing the quality of herbal ingredients and traditional drugs.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of adjustment

This Circular provides for the application of quality standards for 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 during the manufacture, cultivation, export, import, distribution, wholesaling, retailing, sale and use of herbal ingredients and traditional drugs in Vietnam, and herbal ingredients and traditional drugs prepared and prescribed within health facilities; procedures for recalling traditional drugs and disposal of recalled drugs.

Article 2. Subject of application

1. This Circular applies to establishments trading in herbal ingredients/ traditional drugs; health facilities applying herbal ingredients/ traditional drugs and authorities, organizations and individuals involving in the quality management of herbal ingredients and traditional drugs in Vietnam.

2. This Circular does not apply to establishments trading in semi-finished herbal ingredients and herbal drugs; individuals farming and harvesting herbs and the ones harvesting natural herbs.

Article 3. Interpretation of terms

For the purpose of this Circular, the terms below are construed as follows:

1. “batch of herbal ingredients” means a specific quantity of herbal ingredients derived from herbs cultivated or harvested at the same place, prepared and processed by an establishment under the same procedures within a particular period of time.

2. “batch of traditional drugs” means a specific quantity of traditional drugs of the same quality produced by a manufacturer under the same procedures within a particular period of time.

3. “shelf life” of herbal ingredient means the predetermined length or period of time that the herbal ingredient may be stored for use and after that its quality is no longer guaranteed. The shelf life may be expressed as an expiry date or as the month and year of expiry (including the last day of such month).

4. “herbal ingredient/ traditional drug quality standards” means documents prescribing technical specifications of herbal ingredients/ traditional drugs, including quality indices, quality levels, testing methods and other technical and management requirements related to the quality of herbal ingredients/ traditional drugs.

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