Circular No. 12/2010/TT-BYT Issuing the List of Main Traditional Medicine Drugs for Use at Medical Examination and Treatment Facilities.

Article 1. Attached to this Circular are the "List of Raw Traditional Medicines" and the "List of Processed Traditional Medicines" mainly used at medical facilities.

Article 2. Scope of regulation, applicable subjects

1. The List of Raw Traditional Medicines and the List of Processed Traditional Medicines attached to this Circular serve as the basis for medical facilities to select, ensuring treatment needs and payment for medicine costs for patients, including those with health insurance cards.

2. The list of medicines issued with this Circular applies to both public and non-public medical facilities.

Article 3. Structure of the List

1. List of Raw Traditional Medicines (Annex 1): Includes 300 raw medicines classified into 27 groups according to the therapeutic categories of traditional medicine.

a) Name of raw medicine: Recorded according to the Vietnamese Pharmacopoeia

b) Origin: Indicates whether the raw medicine is from southern or northern regions

c) Scientific name of raw medicine: Recorded according to the Vietnamese Pharmacopoeia

d) Scientific name of plant, animal, or mineral used as medicine.

2. List of Processed Traditional Medicines (Annex 2): Includes 127 processed traditional medicines classified into 11 groups according to the therapeutic categories of traditional medicine.

a) Name of medicine or active ingredient: Records the common name of traditional prescriptions, common name of medicine, or active herbal ingredients for medicines without a common name.

b) Formulation

c) Route of administration

d) Notes: Records specific names of some preparations listed under the medicine/active ingredient column

Article 4. Guidance on Using the List

1. For the List of Raw Medicines:

a) Applicable to all levels of medical facilities but must comply with prescription regulations and technical level distribution rules as prescribed by the Ministry of Health and be consistent with the professional capabilities of traditional medicine doctors, traditional medicine assistants, or licensed practitioners prescribing at healthcare facilities.

b) For raw medicines that include foreign-origin Ganoderma lucidum, Astragalus membranaceus, and Panax ginseng, prior consultation is required before prescribing their use. Consultation procedures follow the consultation regulations issued by the Ministry of Health.

2. For the List of Processed Medicines:

a) Applicable to all levels of medical facilities but must comply with prescription regulations and be consistent with professional capabilities and technical level distribution rules as prescribed by the Ministry of Health.

b) Medicines in this group used to treat diseases outside their designated category will be covered by the Health Insurance Fund if they have the efficacy and indications registered in the approved drug registration dossier for circulation in Vietnam.

Article 5. Establishing Specific Medicine Lists for Each Medical Facility and Responsibilities of Medical Facilities

1. Based on the List and guidance on using the List issued with this Circular, taking into account local disease patterns and the health insurance fund's payment capacity, medical facilities shall select and establish a List of Traditional Medicines for use at their facility to organize supply and use for patients. For processed medicines listed under the Common Names in the List of Processed Traditional Medicines issued with this Circular: when establishing the medicine list at the facility, the specific processed medicine name can be recorded as either the common name or the specific name of a legally permitted medicine in Vietnam.

2. Selection of specific processed medicines (including traditional medicines self-manufactured by medical facilities and substitute medicines as stipulated in Clause 3, Article 5 of this Circular) for use at medical facilities should prioritize medicines from pharmaceutical enterprises meeting Good Manufacturing Practice (GMP) standards, effective medicines, and reasonable cost.

3. Selecting substitute medicines for those in the list: In cases where the substitute medicine has similar components, efficacy, and indications as those in the List of Processed Traditional Medicines issued with this Circular, which still have valid registration numbers and are produced at facilities meeting GMP standards or at facilities holding certificates of compliance for producing medicines from herbs, such substitute medicines may replace those in the List of Processed Traditional Medicines issued with this Circular.

4. Finished products manufactured by medical facilities for their own use in patient care, following approved production processes and quality standards, will be reimbursed if all raw medicine components are included in the List of Raw Traditional Medicines issued with this Circular.

5. Medical facilities are responsible for ensuring adequate, timely, and compliant supply of medicines; adhering to prescription, indication, and rational, safe, and effective use of medicines.

Article 6. Payment for Patients' Costs

1. For patients paying out-of-pocket: based on regulations and guidelines on hospital fee collection, medicine payment, and loss rates for traditional medicines as prescribed by competent authorities, medical facilities directly settle payments with patients.

2. For patients with health insurance cards: medical facilities coordinate with the Social Insurance to settle medicine costs for patients according to the Health Insurance Law and implementing guidelines.

3. The Department of Health shall take the lead and coordinate with relevant agencies and the Social Insurance to unify the rate of depreciation (not exceeding the maximum rate prescribed by the Ministry of Health), other cost ratios for traditional medicine ingredients, and production costs for traditional medicine preparations self-manufactured by healthcare facilities for reimbursement to patients and the health insurance fund.

4. In cases where medicines are provided through programs or projects, the health insurance fund will not reimburse them.

Article 7. Effectiveness

This Circular takes effect from June 15, 2010.

Abolish the list of traditional medicine ingredients, the list of traditional medicine preparations, and the guidance on using the Traditional Medicine Drug List issued together with Decision No. 05/2008/QĐ-BYT dated February 1, 2008 of the Minister of Health on the list of main drugs used at healthcare facilities, Decision No. 10/2008/QĐ-BYT dated February 22, 2008 on supplementing the list of traditional medicine preparations issued together with Decision No. 05/2008/QĐ-BYT dated February 1, 2008, and Section B of the Drug Group from Herbal Medicines attached to Circular No. 02/2010/TT-BYT dated January 15, 2010 of the Minister of Health. During the implementation process, if there are difficulties or obstacles, units are requested to report to the Ministry of Health for consideration and resolution.

During the implementation process, if there are difficulties or obstacles, units are requested to report to the Ministry of Health for consideration and resolution./.