Circular No. 19/2018/TT-BYT promulgates the List of Essential Medicines.

CIRCULAR

Issuing the Essential Medicine List

Pursuant to Law on Medicines No.105/2016/QH13of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health3 April 6, 2016;

Pursuant to the Government Decree No. 75/2017/NĐ-CP dated June 20, 2017transmitted, the Director of the Department of Medicine Management;;

Article 1. This Circular stipulates the principles for building, selection criteria, management, and issuance of the List of precious, rare and endemic medicinal plants that must be controlled (hereinafter referred to as the List). of the Ministry of Healthissues this Circular on issuing the list of essential medicines

MinisterThis Circular stipulates the principles for building and criteria for selecting essential medicines including chemical drugs, vaccines, biological products, traditional medicines, and herbal medicines; the list of essential medicines; the use of the list of essential medicines and responsibilities for implementation. Article 2. Principles for Building and Criteria for Selecting Medicines into the List of Essential Medicinesquarantine upon import.

Article 1. Scope of Regulation

1. Principles for Building the List of Essential Medicines:

a) Based on the criteria for selecting medicines prescribed in Clause 2 of this Article, diagnostic and treatment guidelines, and specialized technical procedures issued by the Minister of Health; inheriting the sixth Vietnam National Essential Medicines List and referring to the World Health Organization's Essential Medicines List;

b) Consistent with policies and laws on medicines, actual usage, and the capacity to ensure medicine supply in Vietnam;

c) Regulations on recording medicine names in the Essential Medicines List:

- Not to record proprietary names of medicines;

- Chemical drugs and biological products: recorded according to the international generic name of the active substance or mixture of active substances in the drug formula;

- Vaccines recorded according to the type of vaccine or component name of the vaccine (for example: hepatitis B vaccine);
- Traditional medicine ingredients recorded according to the name of the herbal ingredient in Vietnamese and scientific name. The Vietnamese name of the herbal ingredient may be called differently but must have the same scientific name;
- Herbal medicines and traditional medicines (excluding traditional medicine ingredients): recorded according to the Vietnamese name of each herbal ingredient or traditional medicine ingredient in the same drug formula. In cases where the Vietnamese name of the herbal ingredient or traditional medicine ingredient has different names, the scientific name of the herbal ingredient shall be referred to.
2. Criteria for Selecting Medicines into the List of Essential Medicines: Medicines are considered for selection into the list of essential medicines when they meet the following requirements:
a) General criteria:

- Ensuring safety and efficacy for users;

- Meeting the health care needs of the majority of the population.

b) Specific criteria:
- Chemical drugs and biological products: prioritizing single-component drugs, if multi-component, must prove that the combination is more beneficial than using individual components regarding efficacy and safety;

- Vaccines: prioritizing vaccines serving the expanded immunization program; vaccines produced in Vietnam and licensed for circulation; vaccines used for large outbreaks; vaccines used to prevent diseases posing serious threats to users' lives;

- Traditional medicines (excluding traditional medicine ingredients), prioritizing: medicines produced in Vietnam; products from national, ministerial, provincial-level research projects and equivalent projects that have been accepted and licensed for circulation; products derived from traditional medicine formulas recognized by the Ministry of Health;
- Traditional medicine ingredients prioritizing: those processed from herbs listed in the Vietnamese Pharmacopoeia; those processed from local herbs with special characteristics; those processed from herbs in the list of cultivated and collected herbs meeting treatment requirements and supply capacity;
- Herbal medicines: prioritizing herbal medicines containing herbs or mixtures of herbs named in the list of traditional medicine ingredients accompanying the list of essential traditional medicine ingredients.
- Traditional herbal medicines prioritized for selection: herbal medicines processed from medicinal materials listed in the Vietnamese Pharmacopoeia; herbal medicines processed from local specific medicinal materials; herbal medicines processed from medicinal materials included in the list of medicinal materials cultivated and collected domestically that meet treatment requirements and supply capacity;
- Herbal drug medicines: prioritize selecting herbal drug medicines containing medicinal materials or mixtures of medicinal materials named in the List of Traditional Herbal Medicines accompanying the list of essential traditional herbal medicines.

Article 3. Essential Medicines List

The accompanying Circular hereby promulgates the essential medicines list, including:

1. The list of essential chemical drugs, vaccines, and biological products (Annex I)

2. The list of traditional medicines, essential traditional herbal medicines, and essential medicinal herbs:

a) Traditional medicines originating from the list of recognized traditional medical formulas by the Ministry of Health and exempted from clinical trials;

b) Medicinal herbs including those that have been granted registration certificates for circulation in Vietnam and contain medicinal herbs listed in the essential traditional herbal medicines list issued with this Circular;

c) Medicines according to the list of traditional medicines that have been granted registration certificates for circulation in Vietnam issued with this Circular (Annex II);

d) The list of essential traditional herbal medicines (Annex II).

Article 4. Use of the Essential Medicines List

The essential medicines list shall be used for the following purposes:

1. To develop unified state policies on investment, price management, capital, taxes, fees, and other issues related to the production, business, storage, testing, export, and import of medicines and raw materials for medicines to ensure sufficient availability of medicines in the essential medicines list for health protection, care, and improvement of people's health.

2. To use in training, teaching, and guiding students on medicine usage at schools offering health-related programs.

3. To establish the list of medicines within the scope of payment by the health insurance fund.

4. To serve as a basis for the Drug and Treatment Council to develop the list of medicines for use in healthcare facilities to meet treatment needs, which will be submitted to the heads of these facilities for approval.

5. To serve as a basis for establishing the tendered medicines list, centralized tendered medicines list, and medicines subject to negotiated pricing.

6. To define the scope of retail sales of medicines at retail outlets such as village health stations, including:

a) Chemical drugs and biological products marked with (*) in the essential chemical drugs and biological products list;

b) All essential medicinal herbs, traditional medicines, and essential traditional herbal medicines issued with this Circular.

Article 5. Effective Date

1. This Circular takes effect from October 15, 2018.

2. Repeal Circular No. 40/2013/TT-BYT dated November 18, 2013, issued by the Minister of Health on the issuance of the essential traditional medicine and herbal medicine list and Circular No. 45/2013/TT-BYT dated December 26, 2013, issued by the Minister of Health on the issuance of the sixth essential chemical medicine list from the date this Circular takes effect.

Article 6. Transitional Provisions

In cases where healthcare facilities use the essential medicine lists stipulated in Circular No. 40/2013/TT-BYT dated November 18, 2013, issued by the Minister of Health on the issuance of the essential traditional medicine and herbal medicine list and Circular No. 45/2013/TT-BYT dated December 26, 2013, issued by the Minister of Health on the issuance of the sixth essential chemical medicine list as a basis for developing the lists specified in Article 4 of this Circular before the effective date of this Circular, they shall continue to implement according to the provisions of the aforementioned documents but must review and update according to the provisions of this Circular within the latest period of 12 months from the date this Circular takes effect.

Article 7. Responsibility for Implementation

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

During implementation, if there are any difficulties, organizations and individuals should promptly report to the Ministry of Health (Department of Medicine Management and Department of Traditional Medicine and Pharmaceutical Management) for consideration and resolution./.