Chương IV Thông tư 13/2018/TT-BYT: Nguồn gốc, xuất xứ của dược liệu, thuốc cổ truyền

Chapter IV

ORIGINS OF HERBAL INGREDIENTS AND TRADITIONAL DRUGS

Article 13. Checking origins of herbal ingredients and traditional drugs

1. Establishments trading in herbal ingredients/ traditional drugs and health facilities applying herbal ingredients/ traditional drugs are required to establish the origin tracing system so as to identify and trace the entire origins of herbal ingredients/ traditional drugs to their cultivation, harvesting, trading and use.

2. The information concerning suppliers and manufacturers of herbal ingredients/ traditional drugs must be traceable during the trading and use thereof by trading facilities and health facilities.

Article 14. Documents attesting origins of herbal ingredients and traditional drugs

1. Documents attesting the origin of imported herbal ingredients which are not in the list of herbal ingredients to be registered include:

a) Certificate of origin (C/O) issued by a competent authority of the exporting country to each batch of herbal ingredients;

b) Certificate of quality (C/Q) and Testing report (enclosed with Vietnamese translations thereof) issued to each batch of herbal ingredients.

2. Documents attesting the origin of herbal ingredients cultivated, harvested or naturally extracted by a domestic establishment meeting the Good Agricultural and Collection Practices (GACP) requirements include: Documents proving the fulfillment of the Good Agricultural and Collection Practices (GACP) requirements by that domestic establishment.

3. Documents attesting the origin of herbal ingredients acquired by a trading facility from domestic individuals cultivating, harvesting or naturally extracting herbal ingredients include: The commitment to sites where herbal ingredients are cultivated and harvested according to the Form No. 06 in the Appendix I enclosed herewith.

4. The document attesting the origin of herbal ingredients in the list of herbal ingredients to be registered is the Certificate of free sale.

5. Documents attesting the origin of traditional drugs include:

a) Documents proving the origins of ingredients of traditional drugs;

b) Certificate of free sale.

Article 15. Retention of documents concerning origins of herbal ingredients and traditional drugs

1. 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:

a) Name of manufacturer or importer of herbal ingredients/ traditional drugs;

b) Information concerning herbal ingredients/ traditional drugs (name, dosage form, concentration or content, batch number, manufacturing date and expiry date, etc.);

c) Quantity of herbal ingredients/ traditional drugs received or supplied;

d) Date of receipt or supply;

dd) Name, address, telephone and email (if any) of the person/ facility supplying or receiving herbal ingredients/ traditional drugs.

2. Manufacturers, importers providing distribution service and wholesalers in charge of distribution service must cooperate with other wholesalers and retailers in establishing a distribution system and adopting measures for monitoring and ensuring the origin traceability as well as monitoring the story and storage conditions of herbal ingredients, traditional drugs and ingredients thereof.

3. Retention period of origin-related documents:

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

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