Circular No. 03/2019/TT-BYT Issuing the List of Domestic Medicines Meeting Treatment Requirements, Prices, and Supply Capacity

CIRCULAR

ISSUING THE LIST OF DOMESTICALLY PRODUCED MEDICINES MEETING TREATMENT REQUIREMENTS, PRICES, AND SUPPLY CAPACITY

Pursuant to the Medicine Law dated April 6, 2016;

PURSUANTPursuant to the Law on Procurement dated November 26,bidding on November 26 in 2013;

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

Pursuant to Decree No. 63/2014/NĐ-CP dated June 26, 2014 of the Government detailing implementation of certain provisions of the Law on Bidding regarding selection of contractors;

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

THE MINISTER OF HEALTH Issuing this Circular to issue the List of domestically produced medicines meeting treatment requirements, prices, and supply capacity.requests regarding treatment, drug prices, and supply capacity.

Article 1. Scope of Regulation

This Circular issues the List of domestically produced medicines meeting treatment requirements, prices, and supply capacity; it stipulates the principles and criteria for building this List.

Article 2. Issuing the List

Attached to this Circular are 640 medicines in the List of domestically produced medicines meeting treatment requirements, prices, and supply capacity.

Article 3. Principles and Criteria for Building the List

1. Principles for Building the List:

a) The List of medicines is built based on medicines produced at domestic production facilities that have been granted circulation registration certificates, meeting disease prevention and treatment requirements at healthcare facilities according to technical criteria of the medicines, having reasonable prices, and ensuring supply capacity for healthcare facilities nationwide.

b) The List of medicines will be updated with additions or deletions as necessary to reflect current realities and ensure timely provision of medicines for disease prevention and treatment activities at healthcare facilities.

2. Criteria for Building the List:

Medicines included in the List must meet all of the following criteria:

a) They belong to the list of tendered medicines;

b) There are at least three (3) registration numbers from at least three (3) domestic manufacturers according to technical criteria groups;

c) The price of domestically produced medicines does not exceed that of imported medicines with equivalent technical criteria (consistent with preferential provisions for domestically produced medicines under the Law on Procurement);

d) Ensuring the supply of medicines to healthcare facilities when not purchasing imported medicines with equivalent technical criteria to domestically produced medicines.

Article 4. Effective date

1. This Circular takes effect from June 1, 2019.

2. Circular No. 10/2016/TT-BYT dated May 5, 2016 of the Minister of Health issuing the List of domestically produced medicines meeting treatment requirements, prices, and supply capacity ceases to be effective from the date this Circular takes effect.

Article 5. Responsibilities for Implementation

1. Healthcare facilities, when preparing tender documents and request documents, must clearly stipulate that they cannot tender imported medicines in the same technical criteria group as domestically produced medicines listed in this Circular.

2. In cases where there is a sudden increase in demand for medicines in the List of domestically produced medicines meeting treatment requirements, prices, and supply capacity that exceeds the supply capacity of domestic production facilities, healthcare facilities need to use imported medicines to meet treatment needs, then based on reports from healthcare facilities and medicine supply situations, the Minister of Health shall decide to tender imported medicines in the same technical criteria group as domestically produced medicines listed in this Circular within a specified period to ensure sufficient medicine supply to meet treatment needs.

5. The Director of the Drug Administration Department, the Head of the Planning and Finance Department, the Director of the Ministry's Office, and the heads of related units are responsible for implementing this Decision.

In the course of implementation, if there are difficulties or obstacles, they are requested to promptly report to the Ministry of Health (Drug Administration Department) for consideration and resolution./.