Circular No. 19/2018/TT-BYT dated August 30, 2018 of the Ministry of Health on introducing list of essential medicines

THE MINISTRY OF HEALTH

CircularNo. 19/2018/TT-BYT dated August 30, 2018 of the Ministry of Health on introducing list of essential medicines

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 6, 2016;

Pursuant to the Government s Decree No. 75/2017/ND-CP dated June 20, 2017 on defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Upon the request of the Director of the Traditional Medicine Administration of Vietnam and the Director of the Drug Administration of Vietnam;

The Minister of Health hereby promulgates the Circular that introduces the list of essential medicines.

Article 1. Scope of adjustment

This Circular prescribes the principles for developing and criteria for selecting essential medicines, including chemical medicines, vaccines, biologicals, traditional medicines and herbal medicines; the list of essential medicines; use of the list of essential medicines and task performance responsibilities.

Article 2. Principles for developing and criteria for selecting medicines appearing on the list of essential medicines

1. Principles for developing the list of essential medicines:

a) The list must be developed on the basis of the criteria for selection of medicines prescribed in Clause 2 of this Article, instructions for diagnosis and treatment as well as technical and professional procedures promulgated by the Minister of Health; must inherit the list of essential medicines of Vietnam (sixth edition) and consult the list of essential medicines of the World Health Organization;

b) The list must comply with the policies and laws on medicines, conform with actual demands and capabilities of supplying medicines in Vietnam;

c) Naming of medicines on the list of essential medicines shall be subject to the following regulations:

- Use of the given names of medicines shall not be accepted;

- Chemical medicines and biologicals shall be classified by the common international names of active ingredients or active compounds used in the composition of medicines;

- Vaccines shall be classified by their types or ingredient names (for instance, Hepatitis B vaccine);

- Traditional medicinal products shall be classified by herbal ingredient names including common Vietnamese names and scientific names. Vietnamese names of herbal ingredients may vary but their scientific names must be the same;

- Herbal medicines and traditional medicines (except traditional medicinal ingredients) shall be classified by the Vietnamese name of each herbal ingredient or medicinal ingredient used in the same medicinal formula. If Vietnamese names of herbal ingredients or medicinal ingredients vary, the scientific names of herbal ingredients shall be preferred.

2. The criteria for selecting medicines eligible to be on the list of essential medicines shall include:

Medicines will be considered to be on the list of essential medicines if the following criteria are satisfied:

a) General requirements:

- Ensure safety and efficaciousness for users;

- Meet the healthcare needs of the population.

b) Specific requirements:

- With respect to chemical medicines and biologicals, single-ingredient medicines shall be preferred. In case of multi-ingredient medicines, it shall be proved that the combination of multiple ingredients with different effects and safety levels brings about more benefits;

- With respect to vaccines, those vaccines used in the expanded program on immunization, those vaccines that are likely to be domestically formulated and approved for circulation in Vietnam, those vaccines used in major epidemics, and those vaccines used for preventing diseases posing dangers to the user s life, shall be preferred;

- With respect to traditional medicines (except traditional medicinal ingredients), those medicines formulated in Vietnam, those medicinal products formulated in State-, Ministry-, provincial-level or equivalent projects which have been tested before acceptance and have obtained certificates of registration for marketing authorization, and those medicinal products derived from the list of traditional medicines which has been approved by the Ministry of Health, shall be preferred;  

- With respect to traditional medicinal ingredients, those medicinal products formulated from herbal ingredients present in the Pharmacopoeia of Vietnam; those medicinal products formulated from indigenous herbal ingredients, and those formulated from herbal ingredients on the list of herbal products that are cultivated or harvested domestically to meet therapeutic demands and supply capabilities, shall be preferred;  

- With respect to herbal medicines, those herbal medicines composed of herbal ingredients or herbal compounds that are named in the list of traditional medicinal ingredients as part of the list of essential traditional medicinal products.

Article 3. List of essential medicines

The list of essential medicines shall be appended to this Circular, including:

1. List of essential chemical medicines, vaccines and biologicals (Appendix I)

2. List of essential traditional medicines, traditional medicinal ingredients and herbal medicines:

a) Traditional medicines derived from the list of traditional remedies which are recognized by the Ministry of Health and are exempted from clinical tests; 

b) Herbal medicines, including those obtaining certificates of marketing authorization in Vietnam and containing herbal ingredients appearing on the list of essential traditional medicinal ingredients hereto appended.

c) Medicines listed according to the list of traditional medicines with certificates of marketing authorization in Vietnam hereto appended (Appendix II);

d) List of traditional medicinal ingredients (Appendix II).

Article 4. Use of the list of essential medicines

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

1. The list assists in developing the unified system of regulatory policies on investment, administration of prices, funds, taxes and fees relating to manufacturing, trading, storage, testing, export and import of medicines and pharmaceutical materials in order to ensure the number of medicines on the list of essential medicines is adequate for the tasks of protecting, taking care of and improving the population s health.

2. The list is used as training, teaching materials and manuals for use of medicines to students and learners of educational institutions with healthcare training disciplines.

3. Based on the list, another list of medicines for which payments are covered by the health insurance fund shall come into existence.

4. The list is served as a basis for the Drug and Medical Treatment Council to prepare the list of medicines used by healthcare establishments to meet treatment demands for submission to the heads of healthcare establishments to seek approval decisions.

5. The list is served as a basis for establishing the list of medicines subject to the bidding process, the list of medicines subject to the centralized procurement process and the list of medicines subject to the price negotiation method.

6. The list defines which medicines are sold at retailing establishments that are communal-level health stations’ drug cabinets, including:

a) Medicines bearing the symbol (*) in the list of essential chemical medicines and biologicals;

b) All of essential herbal medicines, traditional medicines and traditional medicinal ingredients hereto appended.

Article 5. Effect

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

2. The Circular No. 40/2013/TT-BYT dated November 18, 2013 of the Minister of Health on promulgation of the list of essential oriental medicines and herbal medicines, and the Circular No. 45/2013/TT-BYT dated December 26, 2013 of the Minister of Health on promulgation of the list of essential modern medicines (sixth edition), shall be repealed from the effective date of this Circular. 

Article 6. Transitional provisions

If healthcare establishments uses the list of essential medicines prescribed in the Circular No. 40/2013/TT-BYT dated November 18, 2013 of the Minister of Health on promulgation of the list of essential oriental medicines and herbal medicines, and the Circular No. 45/2013/TT-BYT dated December 26, 2013 of the Minister of Health on promulgation of the list of essential modern medicines (sixth edition), as a basis for developing the lists specified in Article 4 hereof before the Circular’s entry into force, they shall be entitled to continue to comply with provisions laid down in the abovementioned legislative documents, but shall be required to carry out any necessary review and update in compliance with this Circular no later than 12 months from the entry into force of this Circular. 

Article 7. Implementation responsibilities

Drug Administration of Vietnam, Traditional Medicine Administration of Vietnam, the Medical Examination and Treatment Administration, the Planning – Finance Department, affiliates of the Ministry of Health, sectoral-level healthcare units, Departments of Health of centrally-affiliated cities and provinces, Vietnam Pharmaceutical Corporation, healthcare service providers, pharmaceutical production and business facilities, organizations and individuals concerned, shall be responsible for implementing this Circular. 

In the course of implementation of this Circular, if there is any difficulty that arises, entities, organizations and individuals should promptly inform the Ministry of Health (Drug Administration of Vietnam, and Traditional Medicine Administration of Vietnam) for its possible decisions./.

For the Minister

The Deputy Minister

Nguyen Viet Tien. 

* All Appendices are not translated herein.