Circular No. 33/2012/TT-BYT Issuing the List of Toxic Herbal Medicines Used for Medicine in Vietnam

CIRCULAR

Issuing the List of Toxic Herbal Medicines Used for Medicine in Vietnam

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Pursuant to the Drug Law dated June 14, 2005;

Pursuant to Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law, and Decree No. 89/2012/NĐ-CP dated October 24, 2012 of the Government amending and supplementing certain provisions of Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law;

Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department;

The Ministry of Health issues this Circular on the issuance of the List of Toxic Herbal Medicines Used for Medicine in Vietnam.

Article 1. Basis for Building the List

The List of Toxic Herbal Medicines Used for Medicine in Vietnam is established based on the following grounds:

1. Scientific evidence regarding safety and toxicity of herbal medicines;

2. Medical literature on the use of traditional medicine, experience in using traditional medicine in Vietnam with components that may cause serious adverse effects (effects that can lead to death, endanger life, require hospitalization for treatment or prolong treatment time, cause severe or permanent disability, birth defects, congenital disabilities, and similar consequences) known and/or recommended to have such effects;

3. Management bases for toxic herbal medicines in some countries in the region such as China and Malaysia.

Article 2. Criteria for Selecting Toxic Herbal Medicines Used for Medicine

Herbal medicines meeting all of the following criteria shall be selected for inclusion in the List of Toxic Herbal Medicines Used for Medicine:

1. Herbal medicines used for medicine with high toxicity causing negative impacts on the health and lives of users;

2. Herbal medicines with toxicity or during use may cause serious adverse effects known and/or recommended to have harmful effects;

3. Herbal medicines used for medicine must pay attention to usage methods, strictly control dosage, user groups, and must be processed according to strict procedures and correct techniques;

4. Herbal medicines with a narrow dosage range, must be cautious when using, affecting diagnosis and treatment of diseases requiring clinical monitoring;

5. Must be prescribed for treatment under the mandatory supervision, consultation, and follow-up by a physician.

Article 3. Issuance of the List of Toxic Herbal Medicines Used for Medicine in Vietnam

Attached to this Circular is the "List of Toxic Herbal Medicines Used for Medicine in Vietnam", which includes:

1. The List of Toxic Herbal Medicines of plant origin specified in Appendix 1;

2. The List of Toxic Herbal Medicines of animal origin specified in Appendix 2;

3. The List of Toxic Herbal Medicines of mineral origin specified in Appendix 3.

Article 4. Structure of the List

The List of Toxic Herbal Medicines specified in Appendices 1, 2, and 3 includes 50 herbal medicines arranged alphabetically by the name of the herbal medicine; the name of the herbal medicine is recorded according to the name stipulated in the Vietnamese Pharmacopoeia or the common name usually called for the herbal medicine. The List of Herbal Medicines has five columns as follows:

1. Column 1 records the serial number: numbered according to the name of the herbal medicine;

2. Column 2 records the name of the herbal medicine in Vietnamese, which is the common name of the herbal medicine;

3. Column 3 records the scientific name (Latin name) of the plant or animal used as medicine or records the nature or main chemical component of the mineral. The scientific name of the plant or animal used as medicine is fully recorded with the genus name, species name, and family name, and may include the author's name. For the column recording the scientific name of plants and animals, the scientific name of one main species or more than two species is recorded as the scientific name of the genus followed by the term "spp." For example, the herbal medicine Strychnine Seed is the dried seed from the ripe fruit of the Strychnine Tree (Strychnos nux-vomica L.) or other species of the Strychnos genus (Strychnos spp.), containing strychnine, belonging to the Loganiaceae family;

4. Column 4 records the part of the plant or animal used as medicine; for the List of Herbal Medicines of mineral origin, it describes the nature or main chemical component of the mineral. In this column, the part used is recorded in Vietnamese and/or Latin;

5. Column 5 records alternative names of the herbal medicine other than the common name recorded in Column 2 or the name of the plant, animal, or mineral used as medicine.

Article 5. Guidelines for Using the List

1. Toxic herbal medicines must be used strictly controlled regarding dosage, users, administration routes, and must be processed according to technical procedures specified by the Ministry of Health.

2. The business and production of medicines using toxic herbs listed in this List of toxic herbs must comply with regulations on pharmaceuticals and safety and efficacy treatment regulations for medicines.

3. Herbs not included in the List of toxic herbs prescribed in this Circular but identified through usage or medical literature, or reported to cause adverse reactions related to herb toxicity, will be reviewed individually by the Ministry of Health in granting permits for circulation and use of medicines containing such herbs, and must adhere to regulations applicable to toxic herbs as stipulated in this Circular.

4. In cases where there is inconsistency in the Vietnamese name of the herb due to differences in local and regional naming practices, the official name of the herb shall be based on its scientific name and the scientific name of the plant or animal used as medicine.

Article 6. Procedures for Proposing Supplemental and Amending the List

Annually, based on scientific research reports on the toxicity of herbs or serious adverse effects of traditional Chinese medicine herbs officially recorded, published, and recognized both domestically and internationally, the Department of Medicines under the Ministry of Health will aggregate and report to the Minister of Health to supplement, amend, or adjust the List of toxic herbs used as medicines in Vietnam to suit current circumstances.

Article 7. Implementation Provisions

This Circular takes effect from April 1, 2013. During implementation, if difficulties arise, units are requested to report to the Ministry of Health (Department of Medicines) for study and appropriate amendments.