Thông tư 40/2013/TT-BYT

CIRCULAR

INTRODUCING THE LIST OF ESSENTIAL ORIENTAL AND HERBAL MEDICINES (6^TH REVISED EDITION)

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

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

After considering the request of the Director of the Traditional Medicine Administration;

The Minister of Health hereby introduces the list of essential oriental and herbal medicines (6^th revised edition) with the following provisions:

Article 1. List of essential oriental and herbal medicines (6th revised edition)

Issued together with this Circular is the List of essential oriental and herbal medicines of Vietnam (6^th revised edition), including:

1. List of oriental and herbal medicines.

2. List of traditional medicine ingredients

3. List of medicinal plants

Article 2. Principle for compilation of the list of essential oriental and herbal medicines (6th revised edition)

1. Uphold the list of essential medicines of Vietnam (5^th revised edition), simultaneously consulting the list of traditional medicines mainly used by healthcare establishments to which health insurance funds are paid and used for traditional therapy processes endorsed by the Ministry of Health.   

2. Comply with laws and policies on medications, meet actual demands and ensure Vietnam’s sufficient supply capability.   

3. Allow the list of essential medicines to be amended or supplemented until they are proven safe to users. Certain medicines may be eliminated from the list if serious harmful effects have been found.

Article 3. Criteria for selecting medicines for the list of essential oriental and herbal medicines

1. Show proven efficacy and safety to users.

2. Ensure the availability of medicines in an adequate quantity, and take dosage forms in conformity with storage, distribution and usage requirements. 

3. Stand compatible with illness models, technical appliances and professional qualifications of practitioners and medical staff working at healthcare establishments.

4. Set reasonable prices

5. Encourage priorities:

a) List of oriental and herbal medicines:

- Finished products made from Vietnamese herbal materials or made in Vietnam;

- Medicinal products with generic names and finished products with their formulas compiled in Vietnam’s pharmacopoeia;

- Finished products made by WHO-GMP-certified pharmaceutical manufacturers;

- Finished products as the results of state, Ministerial or equivalent-level scientific researches which have passed the acceptance testing and licensed for circulation;

- Finished products indicated in the note section of the list, which are required to meet the following criteria: deriving from ancient remedies, taking dosage forms which are appropriate and convenient for the storage, distribution and treatment process, and adhering to the principle of combination of traditional and modern medications.

b) List of traditional medicine ingredients:

- Those that currently exist in Vietnam’s pharmacopoeia;

- Those which have already been studied and proven safe and efficacious;

- Those grown and processed by GACP-WHO-certified places and other indigenous ones.

c) List of traditional Vietnamese herbs:

- Those found available in Vietnam;

- Those adapted well to pedological and climatic conditions of different regions;

- Those used for treating common conditions and illnesses in the community.

Article 4. Implementation guidance on the list of essential oriental and herbal medicines

1. The list of essential oriental and herbal medicines shall emerge as the basis for:

a) Establishing consistent state policies on investment, administration of price, capital, tax and issues concerning medicines used for preventing or curing human diseases, which shall ensure the adequacy of medicines defined in the list of essential medicines to serve the purpose of protecting, taking care of and improving people’s health;  

b) Involving state agencies in providing guidelines and policies which facilitate grant of registration numbers for medicine circulation, pharmaceutical product export and import;

c) Involving health-related affiliations in focusing on their operations at different stages, such as export, import, production, supply, distribution, storage and usage of essential medicines in a safe, rational and effective manner in order to meet people’s healthcare demands;

d) Involving pharmacy and medicine colleges or universities in organizing activities of training, teaching and providing learners and students with instructions for drug usage;

dd) Involving pharmacies in ensuring that essential medicines defined in the list shall be sold at the reasonable price; in providing instructions for safe, proper and effective drug usage;

e) Compiling the list of medicines covered by health insurance;

g) Involving the Council for medicines and therapies in compiling the list of medicines used by hospitals in order to meet medical treatment demands and submitting it to the hospital Director for approval. 

2. Guidance on the use of the list of essential medicines:

a) Lists of traditional medicine ingredients, finished medicinal products and medicinal plants shall be applicable to all healthcare networks and all of items in the list shall be arranged in order of medicinal efficacy;

b) Names of medicines or medicinal ingredients specified in the list of finished medicinal products in the annex shall obey the following rules: generic names in terms of medicines used in ancient remedies, or medicines with generic names, and names of herbal ingredients in terms of medicines without generic names; 

c) Finished products with ingredients, useful effects and indications which are the same as those of finished products defined in approved lists shall be used as substitutes for medicines mentioned in these lists;

d) Medicinal plants specified in the list shall be grown and used at model herbal gardens of commune and ward healthcare stations, healthcare establishments and training centers. In the course of implementation, healthcare units shall be entitled to replace existing medicines with available ones in order to conform to the illness model of specific localities.

Article 5. Implementary provisions

1. This Circular shall enter into force from January 1, 2014.

The Decision No. 17/2005/QD-BYT of the Minister of Health dated July 1, 2005 on introduction of the list of essential medicines of Vietnam (5^th revised edition) (with respect to the part of the list of essential traditional medicines) shall be abolished from the date of this Circular’s entry into force. 

2. The Traditional Medicine Administration of Vietnam, Medical Examination and Treatment Administration, Plan – Finance Department and affiliations of the Ministry of Health, health-related units of specific industries, Health Department of centrally-affiliated cities and provinces, Vietnam Pharmaceutical Corporation, and pharmaceutical manufacturing and trading companies, shall be held responsible for implementing this Circular.

During the process of implementation, if there is any difficulty that may arise, organizations and individuals must send timely feedbacks to the Ministry of Health (the Traditional Medicine Administration) for consideration and solutions./.