Circular No. 45/2013/TT-BYT Issuing the Sixth List of Essential Medicines - Modern Drugs

CIRCULAR

Issuing the Sixth Essential Medicine List for New Drugs

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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 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 Minister of Health issues this Circular on Issuing the Sixth Essential Medicine List for New Drugs as follows:

Article 1. The Sixth Essential Medicine List

Attached to this Circular is the "Sixth Essential Medicine List for New Drugs".

Article 2. Principles for Building the Sixth Essential Medicine List for New Drugs

1. Inheriting the Fifth National Essential Medicine List, while also referring to the current World Health Organization Essential Medicines List, treatment guidelines of the Ministry of Health of Vietnam, and based on specific drug selection criteria;

2. Being consistent with drug-related policies and laws, actual usage, and the ability to ensure drug supply in Vietnam;

3. The Essential Medicine List for New Drugs will be revised and supplemented to ensure safety for users; some types of drugs may be removed from the list if serious adverse effects are discovered;

4. Drugs included in the Essential Medicine List for New Drugs will be listed under their international nonproprietary names, without including proprietary names.

Article 3. Criteria for Selecting Drugs for the Essential Medicine List for New Drugs

1. Ensuring efficacy and safety for users;

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

3. Being compatible with disease patterns, technical means, and the qualifications of medical practitioners and health workers in healthcare facilities;

4. Having reasonable prices;

5. Mostly being single active ingredients; if they are combination products, they must demonstrate that the combination provides greater benefits than using each component separately in terms of efficacy and safety. In cases where there are two or more similar drugs, selection should be based on a comprehensive evaluation of efficacy, safety, quality, price, and supply capacity.

Article 4. Guidelines for Implementing the Essential Medicine List for New Drugs

1. The Essential Medicine List for New Drugs serves as a basis for:

a) Developing unified national policies on investment, pricing, capital, taxation, and other issues related to preventive and curative medicines to create conditions for ensuring adequate availability of essential medicines in the list to serve public health protection and improvement.

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

c) Healthcare units focusing their activities in areas such as export, import, production, supply, distribution, storage, and rational, safe, and effective use of essential medicines to meet public health needs.

d) Medical and pharmaceutical training institutions organizing education and guidance on the use of medicines for students.

đ) Pharmaceutical business establishments ensuring the availability of essential medicines in the list at appropriate prices and providing guidance on their safe, rational, and effective use.

e) Establishing a list of medicines within the scope of payment by the Health Insurance Fund.

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 Essential Medicine List for New Drugs:

a) Using in accordance with:

+ The scope of professional activities stipulated in the operating license of healthcare facilities;

+ The technical catalog of healthcare facilities approved by competent authorities according to regulations.

b) Medicines marked with (*) can be sold up to the pharmacy cabinets of health stations and retail outlets of enterprises.

c) Medicines marked with (**) are reserve medicines, restricted for use, and should only be used when other medicines in the treatment group are ineffective and must be reviewed by a consultation meeting (except in emergency situations).

d) Methadone marked with (***) is used in healthcare facilities authorized to implement substitution therapy programs for opiate addiction; the target population and duration of use must comply with the "Guidelines for Opiate Substitution Therapy with Methadone" issued by the Ministry of Health.

e) Other cases:

- Specific medicines for leprosy, mental illness, epilepsy, infertility, tuberculosis, HIV/AIDS, malaria, and vaccines used according to the guidelines of relevant health programs.

- For sedatives, anticonvulsants, antidepressants, in communities implementing community mental health programs, their use is permitted according to the provisions of those programs.

- Antiviral drugs that temporarily slow down viral development and improve symptoms. These drugs cause different adverse reactions, and patients treated with them need careful monitoring by qualified medical professionals.

Article 5. Implementation Provisions

1. This Circular takes effect from February 10, 2014. Decision No. 17/2005/QĐ-BYT dated July 1, 2005 of the Minister of Health on issuing the Fifth National Essential Medicine List (the part on the Essential Medicine List for New Drugs) is abolished from the date this Circular takes effect.

2. The Drug Administration Department, the Department of Medical Examination and Treatment, the Health Insurance Department, units under and affiliated with the Ministry of Health, healthcare units, provincial and municipal health departments, the Vietnam Pharmaceutical Corporation, and pharmaceutical manufacturing and trading enterprises are responsible for implementing this Circular.

Any issues encountered during implementation should be promptly reported to the Ministry of Health (Drug Administration Department) for consideration and resolution./.