Thông tư 45/2013/TT-BYT Danh mục thuốc thiết yếu tân dược lần VI

THE MINISTRY OF HEALTH

Circular No. 45/2013/TT-BYT dated December 26, 2013 of the Ministry of Health on promulgation of the list of essential modern medicines (sixth edition)

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

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

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

The Minister of Health promulgating the fourth list of essential western medicines as follows:

Article 1. The fourth list of essential medicines

To issue with this Circular “the list of essential modern medicines (sixth edition)".

Article 2. The principles to elaborate the fourth list of essential modern medicines

1. To take over the fifth list of Vietnam essential medicines, with reference of the existing list of essential medicines of World Health Organization, cure guides of the Ministry of Health and based on specific criteria in medicine selection;

2. In conformity with policy and law on pharmacy, practical use and ability to ensure the medicine supply of Vietnam;

3. The list of essential modern medicines is amended and supplemented to ensure safety for users, some kinds of medicine may be removed from the list if they detect adversely effects;

4. Medicines are put into list of essential modern medicines under international common names, not use private name of preparations.

Article 3. Criteria to select medicines to put into the list of essential modern medicines  

1. To ensure efficiency and safety for users;

2. To be available in adequate amounts and in dosage forms appropriate to conditions of preservation, supply and use;

3. To be suitable with disease model, technological means, qualification of physicians and health officers in medical examination and treatment establishments;

4. Sensible price;

5. Majority is element, in case of compound, it must prove that such combination is more useful than use of each separate element regarding effect and safety. If there are two or more similar medicines, they must be selected on the basis of assessing sufficiently the efficiency, safety, quality, price and supply ability. 

Article 4. Implementation guide on the list of essential modern medicines

1. The list of essential modern medicines is basis to:

a) To elaborate the State’s unified policies on: Investment, price management, capital, tax, matters involving curative medicine to human aiming to facilitate to have sufficient medicines in list of essential medicines in serve of protection, care and raising people’s health. 

b) State management agencies may formulate guidelines, policies in facilitating to issue the medicine circulation registration number, medicine export and import.

c) Units in Health sector concentrate on their activities in stages: The safe, sensible and efficient export, import, production, supply, distribution, storage and use of essential medicines aiming to meet demand of people s protection and healthcare.

d) Schools specialized in Health, pharmacy organize the training, teaching and guide of medicine use for pupils and students.

dd) Establishments trading in medicine ensure to have essential medicines in the list at a sensible price; guide on safe, sensible and effective medicine usage. 

e) To elaborate list of medicines in payment scope of medical insurance fund.

g) The medicine and medical treatment council may elaborate list of medicine used in hospital to meet demand of medical treatment and submit to director of hospital for the approval.

2. Guide on use of the list of essential modern medicines:

a) Use in line with:

+ The specialized operational scope in operation permit, for medical examination and treatment establishments;

+ Technical list of medical examination and treatment establishments which have been approved by competent authorities under regulations.

b) Medicines with symbol (*) have retail scope at medical stations and medicine sale agents of enterprises.

c) Medicines with symbol (**) are reserve medicines limited for use, only used when other medicines in medical treatment group are not effective and required specialist diagnostic (except for case of first aid).

d) Methadone medicines with symbol (***) are used in medical establishments allowed to implement program on addiction treatment of opium substances by alternative drugs; objects using medicines and time of medicine usage must comply with “The medical treatment guide to alternate addition of opium substances by methadone medicines” promulgate by the Ministry of Health.

e) Cases:

- Special curative medicines for leprosy, mental illness, seizures, infertility, tuberculosis, HIV / AIDS, malaria and vaccines are used in accordance with guide of health programs.

- For sedatives, antiepileptic drugs, antidepressants, in case where communes, wards implement community mental health program, they are allowed using in accordance with regulation of that program.

- Antiviral medicines have effect to temporarily delay development of virus, and improve symptoms. These medicines cause various adverse reactions and during being treated with these medicines, patients need careful supervision from physicians and health officers with suitable qualification.

Article 5. Implementation provisions

1. This Circular takes effect on February 10, 2014. To annul Decision No. 17/2005/QD- BYT dated July 01, 2005, of Minister of Health, on promulgating the fifth list of Vietnam’s essential medicines (part list of essential modern medicines) from the effective day of this Circular. 

2. The Drug Administration of Vietnam, the medical examination and treatment management Department, medical insurance department, units of and affiliated the Ministry of Health, units of health sector, the principal/municipal Services of Health,  Vietnam Pharmaceutical Corporation, enterprises producing and trading in pharmaceutical products shall implement this Circular.

In the course of implementation, any arising problems should be reported timely to the Ministry of Health (the Drug Administration of Vietnam) for consideration and settlement.

The Minister of Health

Nguyen Thi Kim Tien

*All appendices are not translated herein.