Circular No. 40/2013/TT-BYT Issuing the List of Essential Traditional Medicine and Herbal Drugs for the Sixth Time

CIRCULAR

ISSUING THE LIST OF ESSENTIAL TRADITIONAL MEDICINE AND HERBAL DRUGS VI

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Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

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

At the proposal of the Director of the Traditional Medicine Management Department;

THE MINISTER OF HEALTH ISSUES THIS CIRCULAR ON THE LIST OF ESSENTIAL TRADITIONAL MEDICINE AND HERBAL DRUGS VI AS FOLLOWS:

Article 1. LIST OF ESSENTIAL TRADITIONAL MEDICINE AND HERBAL DRUGS VI

ANNEXED TO THIS CIRCULAR IS THE "LIST OF ESSENTIAL TRADITIONAL MEDICINE AND HERBAL DRUGS VI OF VIETNAM", INCLUDING:

1. List of traditional medicine and herbal drugs.

2. List of traditional medicinal herbs.

3. List of medicinal plants.

Article 2. PRINCIPLES FOR ESTABLISHING THE LIST OF ESSENTIAL TRADITIONAL MEDICINE AND HERBAL DRUGS VI

1. Inheriting the List of Essential Medicines Vietnam V while referring to the list of main traditional medicines used at healthcare facilities covered by health insurance funds and the treatment procedures using traditional medicine issued by the Ministry of Health.

2. Consistent with policies and laws on medicine, actual usage, and supply capacity in Vietnam.

3. The List of Essential Medicines will be revised and supplemented to ensure safety for users; some types of medicine may be removed from the list if serious harmful effects are discovered.

Article 3. CRITERIA FOR SELECTING MEDICINES TO BE INCLUDED IN THE LIST OF ESSENTIAL TRADITIONAL MEDICINE AND HERBAL DRUGS

1. Ensuring effectiveness and safety for users.

2. Being readily available in sufficient quantities, with appropriate formulations suitable for storage, supply, and use conditions.

3. Suitable for disease patterns, technical means, and professional qualifications of medical practitioners and healthcare staff in healthcare facilities.

4. Reasonable pricing.

5. Encouraging priority:

a) For the list of traditional medicine and herbal drugs:

- Formulations produced from Vietnamese medicinal materials or manufactured in Vietnam;

- Medicines with common names and formulations included in the Vietnamese Pharmacopoeia;

- Formulations produced in manufacturing facilities that comply with Good Manufacturing Practice (GMP) guidelines recommended by the World Health Organization (WHO);

- Formulations under national, ministerial, and equivalent research projects that have been accepted and registered for circulation;

- Formulations referenced in the list must meet criteria such as being derived from ancient prescriptions, having appropriate formulations, facilitating storage, distribution, and use, and ensuring the integration of traditional and modern medicine principles.

b) For the list of traditional medicinal herbs:

- Included in the Vietnamese Pharmacopoeia;

- Herbs that have been studied and proven safe and effective;

- Herbs grown and processed according to Good Agricultural and Collection Practices (GACP) guidelines recommended by WHO and those specific to local areas.

c) For the list of Southern medicinal plants:

- Plants available in Vietnam;

- Suitable for soil and climate conditions in different regions;

- Treating common diseases in communities.

Article 4. GUIDELINES FOR IMPLEMENTATION OF THE LIST OF ESSENTIAL TRADITIONAL MEDICINE AND HERBAL DRUGS

1. The List of Essential Traditional Medicine and Herbal Drugs serves as a basis for:

a) Establishing unified state policies on investment, price management, capital, tax, and issues related to preventive and curative medicines to ensure adequate availability of essential medicines listed for public health protection and improvement;

b) State management agencies formulating policies to facilitate registration for circulation, export, and import of medicines;

c) Healthcare units focusing on activities in export, import, production, supply, distribution, storage, and rational, safe, and effective use of essential medicines to meet public health needs;

d) Specialized medical and pharmaceutical schools organizing training, teaching, and guidance on the use of medicines for students;

e) Ensuring essential medicines in the list at reasonable prices; providing guidance on safe, rational, and effective use of medicines;

f) Establishing the List of Medicines Covered by Health Insurance;

g) The Drug and Treatment Council developing a list of medicines for hospital use to meet treatment needs and submit it for approval by the Hospital Director.

2. Guidelines for Using the List of Essential Medicines:

a) The list of traditional medicinal herbs, formulations, and plants can be used across all levels of healthcare facilities and arranged by drug functions;

b) Drug names or components listed in the annex of the formulation list: common names for traditional prescriptions and drugs with common names, component names for drugs without common names;

c) Formulations with similar components, uses, and indications as those in the list can replace the medicines listed;

d) Medicinal plants in the list can be cultivated and used in model herb gardens at commune health stations, healthcare facilities, and training institutions. During implementation, units may substitute certain plants with locally available ones suitable for local disease patterns.

Article 5. Implementation Provisions

1. This Circular takes effect from January 1, 2014.

DECISION NO. 17/2005/QĐ-BYT dated July 1, 2005 of the Minister of Health on issuing the List of Essential Medicines Vietnam V (Traditional Medicine Section) is abolished from the date this Circular takes effect.

2. The Department of Traditional Medicine and Pharmaceutical Management, the Department of Medical Examination and Treatment Management, the Department of Planning and Finance, subordinate units of the Ministry of Health, health sector units, provincial and municipal health departments, the Vietnam Pharmaceutical Corporation, and pharmaceutical production and trading enterprises are responsible for implementing this Circular.

Any difficulties encountered during implementation should be promptly reported to the Ministry of Health (Department of Traditional Medicine and Pharmaceutical Management) for consideration and resolution.