Circular No. 15/2022/TT-BYT amends and supplements some articles and Appendices in Circular No. 03/2019/TT-BYT dated March 28, 2019, issued by the Minister of Health on the List of Domestic Medicines Meeting Treatment Requirements, Drug Prices, and Supply Capacity, and Circular No. 15/2020/TT-BYT dated August 10, 2020, issued by the Minister of Health on the List of Tendered Drugs, Centralized Tendering List, and Negotiated Price List.

CIRCULAR

Amending and supplementing certain Articles and Appendices in Circular No. 03/2019/TT-BYT dated March 28, 2019 issued by the Minister of Health on the List of Domestic-Made Medicines Meeting Treatment Requirements, Medicine Prices, and Supply Capacity and Circular No. 15/2020/TT-BYT dated August 10, 2020 issued by the Minister of Health on the List of Tendered Medicines, the Centralized Tendered Medicine List, and the List of Medicines Subject to Negotiated Pricing

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

Pursuant to the Public Procurement Law No. 43/2013/QH13 dated November 26, 2013;

Pursuant to Decree No. 95/2022/NĐ-CP dated November 15, 2022 of the Government 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 the implementation of certain provisions of the Public Procurement Law concerning the selection of contractors;

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

The Minister of Health hereby issues this Circular amending and supplementing certain Articles and Appendices in Circular No. 03/2019/TT-BYT dated March 28, 2019 issued by the Minister of Health on the List of Domestic-Made Medicines Meeting Treatment Requirements, Medicine Prices, and Supply Capacity and Circular No. 15/2020/TT-BYT dated August 10, 2020 issued by the Minister of Health on the List of Tendered Medicines, the Centralized Tendered Medicine List, and the List of Medicines Subject to Negotiated Pricing.

Article 1. Amending and supplementing certain Articles and Appendices in Circular No. 03/2019/TT-BYT dated March 28, 2019 issued by the Minister of Health on the List of Domestic-Made Medicines Meeting Treatment Requirements, Medicine Prices, and Supply Capacity (hereinafter referred to as Circular No. 03/2019/TT-BYT):

1. Repealing 11 medicines in the Appendix of the List of Domestic-Made Medicines Meeting Treatment Requirements, Medicine Prices, and Supply Capacity issued together with Circular No. 03/2019/TT-BYT (Detailed list of 11 medicines in the Appendix issued together with this Circular).

2. Amending the concentration and content of medicine number 166 in the Appendix of the List of Domestic-Made Medicines Meeting Treatment Requirements, Medicine Prices, and Supply Capacity issued together with Circular No. 03/2019/TT-BYT from "100mg" to "100mg/10ml".

3. Amending the unit of measurement for medicine number 466 in the Appendix of the List of Domestic-Made Medicines Meeting Treatment Requirements, Medicine Prices, and Supply Capacity issued together with Circular No. 03/2019/TT-BYT from "tablet" to "package".

4. Repealing Clause 3 and Clause 4 of Article 5 of Circular No. 03/2019/TT-BYT.

Article 2. Amending and supplementing certain Articles and Appendices in Circular No. 15/2020/TT-BYT dated August 10, 2020 issued by the Minister of Health on the List of Tendered Medicines, the Centralized Tendered Medicine List, and the List of Medicines Subject to Negotiated Pricing (hereinafter referred to as Circular No. 15/2020/TT-BYT) as follows:

1. Amending Appendix I. The List of Tendered Medicines issued together with Circular No. 15/2020/TT-BYT, specifically as follows:

a) Amending the title of Part I from "Part I. List of Modern Medicines" to "Part I. List of Chemical Medicines";

b) Amending the active ingredient of medicine number 148, Part I, from "Bọ mắm, Eucalyptol, Núc nác, Viễn chí, Trần bì, An tức hương, Húng chanh, Matri benzoat" to "Bọ mắm, Eucalyptol, Núc nác, Viễn chí, Trần bì, An tức hương, Húng chanh, Natri benzoat";

c) Amending the active ingredient of medicine number 16, Part III, from "Artiso, Nghệ, Rau má" to "Actiso, Nghệ, Rau má".

2. Amending Appendix II. The Centralized National Tendered Medicine List issued together with Circular No. 15/2020/TT-BYT, specifically as follows:

a) Amending the active ingredient of medicine number 16, Section B, from "Lamivudin + Tenofovir + Efavirenz" to "Lamivudin + Tenofovir disoproxil fumarat + Efavirenz";

b) Amending the active ingredient of medicine number 17, Section B, from "Lamivudin + Tenofovir" to "Lamivudin + Tenofovir disoproxil fumarat";

c) Amending the active ingredient of medicine number 26, Section B, from "Tenofovir" to "Tenofovir disoproxil fumarat";

d) Amending the active ingredient of medicine number 16, Item I, Section C, from "Lamivudin + Tenofovir + Efavirenz" to "Lamivudin + Tenofovir disoproxil fumarat + Efavirenz";

đ) Amending the active ingredient of medicine number 17, Item I, Section C, from "Lamivudin + Tenofovir" to "Lamivudin + Tenofovir disoproxil fumarat";

e) Amending the active ingredient of medicine number 27, Item I, Section C, from "Tenofovir" to "Tenofovir disoproxil fumarat";

g) Amending the active ingredient of medicine number 8, Item III, Section C, from "Ethambutol" to "Ethambutol hydrochloride";

h) Amending the active ingredient of medicine number 14, Item VI, Section C, from "Sulperid" to "Sulpirid".

3. Amending Appendix III. The List of Medicines Subject to Negotiated Pricing issued together with Circular No. 15/2020/TT-BYT, specifically as follows:

a) Amending the name of medicine number 69, Part I, from "Rocephin 1g I.V" to "Rocephin 1g I.V.";

b) Amending the concentration/content of medicine number 350, Part II, from "775mg/ml (equivalent to 350mg Iod/ml)" to "755mg/ml (equivalent to 350mg Iod/ml)";

c) Amending the active ingredient of medicine number 1, Part IV, from "Tenofovir; Lamivudin; Dolutegravir" to "Tenofovir disoproxil fumarat; Lamivudin; Dolutegravir";

d) Amending the active ingredient of medicine number 2, Part IV, from "Tenofovir; Lamivudin; Efavirenz" to "Tenofovir disoproxil fumarat; Lamivudin; Efavirenz".

4. Repealing Article 4 of Circular No. 15/2020/TT-BYT.

Article 3. Effectiveness

This Circular shall take effect from February 1, 2023.

The Heads of the Office of the Ministry; the Director of the Drug Administration Department; the Director of the Traditional Medicine Management Department; the Head of the Planning and Finance Department; the Inspector General of the Ministry; the Director of the National Centralized Medicine Procurement Center; the Heads of units under and affiliated with the Ministry of Health; the Directors of Provincial Health Departments; pharmaceutical business establishments; and other relevant agencies, organizations, and individuals are responsible for implementing this Circular.

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./.