Thông tư 26/2019/TT-BYT quy định về danh mục thuốc hiếm

CIRCULAR

On lists of orphan drugs

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

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

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

The Minister of Health promulgates the Circular on lists of orphan drugs.

Article 1. Scope of regulation

This Circular issues lists of orphan drugs and provides purposes for issuance and principles of formulation of, and criteria for selection of drugs to, the lists of orphan drugs.

Article 2. Lists of orphan drugs

The lists of orphan drugs issued in the Appendix to this Circular include:

1. The list of drugs for prevention, diagnosis and treatment of rare diseases.

2. The list of unavailable drugs.

Article 3. Purposes of issuance of the lists of orphan drugs

1. The list of drugs for prevention, diagnosis and treatment of rare diseases shall serve as a basis for:

a/ State competent agencies to consider exemption from or reduction of requirements on clinical data or exemption from one or more than one stage of clinical trial before licensing the sale of drugs prescribed in Clause 3. Article 18 of the Minister of Health’s Circular No. 32/2018/TT-BYT of November 12, 2018, prescribing the registration of drugs and drug materials (below referred to as Circular No. 32/2018/TT-BYT);

b/ Competent state agencies to study data from drug stability studies as prescribed at Point a, Clause 2, Article 25 of Circular No. 32/2018/TT-BYT;

c/ State management agencies to give priority in terms of the order and procedures for registration for sale of drugs as prescribed in Clause 1, Article 34 of Circular No. 32/2018/TT-BYT;

d/  State management agencies to license the import of drugs in accordance with law;

dd/ Making the payment of drug wastage costs under the regulation on drug wastage rates of drugs and payment of drug wastage costs at medical examination and treatment establishments.

2. The list of unavailable drugs shall serve as a basis for related agencies and organizations to implement the provisions at Points c, d, and dd, Clause 1 of this Article.

Article 4. Principles for formulation of the lists of orphan drugs

The lists of orphan drugs shall be formulated in adherence to the following principles:

1. To base on guidelines on diagnosis and treatment and specialized and technical processes issued by the Ministry of Health, the World Health Organization (WHO), and referential management agencies (including the European Medicines Agency (EMA), and medicine agencies of the US, Japan, UK, Switzerland, and Australia) or prestigious domestic, regional and international medical associations (including the Vietnam National Heart Association, associations for the study of liver in Asia and Europe; American College of Rheumatology and European League Against Rheumatism; European Society of Cardiology; American College of Cardiology; American Diabetes Association, and other prestigious medical associations).