Joint Circular No. 36/2013/TTLT-BYT-BTC amending and supplementing certain articles of Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012, issued by the Ministry of Health and the Ministry of Finance guiding the tender for purchasing medicines in healthcare facilities.

JOINT CIRCULAR

Amending and supplementing certain Articles of TCircular Jointly Issued No. 01/2012/TTLT-BYT-BTC dated January 19, 2012

of the Ministry of Health and the Ministry of Finance guiding the procurement B||| Re of medicines in healthcare facilities B||| Tpursuant to Law on Bidding No. 34/2005/QH11 dated November 14, 2005, Law Amending and Supplementing Certain Provisions of Laws Related to Investment in Construction No.

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Pursuant to the Medicine LawNo. 61/2005/QH11 dated November 29, 2005;June 2024;107/2012/NĐ-CP ngày 20 tháng 12 năm 2012 của Chính phủ quy định chức năng, nhiệm vụ, quyền hạn và cơ cấu tổ chức;

Pursuant to Decision No.No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing certain provisions of the Medicine Law, Decree No.No. 89/2012/NĐ-CP dated October 24, 2012 of the Government amending Decision No.ầ79/2006/NĐ-CP dated August 9, 2006 of the Government detailing certain provisions of the Medicine Law;No. Pursuant to Decision No.

Pursuant to DecreeNo. 85/2009/NĐ-CP dated October 15, 2009 of the Government guiding the implementation of the Law on Bidding and the selection of construction contractors under the Construction Law;i This Circular is promulgated with the National Technical Regulation on Quality of Fixed Land Broadband Internet Access Service (QCVN 34:2019/BTTTT).i Pursuant to Decree No. 11/2020/NĐ-CP dated October 15, 2020 of the Government detailing implementation of certain provisions and measures for organizing the implementation of the Law on Petitions;No. Pursuant to Decision No.No. 08/2012/NĐ-CP dated December 24, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Finance;, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CPm, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CP the Government amending and supplementing certain provisions of Decree No.No. Pursuant to Decision No.June 2024;118/2008/NĐ-CP dated November 27, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Finance;Deputy ministers of ministerial-level agencies, detailing andi Pursuant to Decree No. 11/2020/NĐ-CP dated October 15, 2020 of the Government detailing implementation of certain provisions and measures for organizing the implementation of the Law on Petitions;No. The Minister of Health and the Minister of Finance issue this Circular jointly amending and supplementing certain contents of Circular Jointly Issued No.

Pursuant to DecreeNo. 01/2012/TTLT-BYT-BTC dated January 19, 2012 guiding the procurement of medicines in healthcare facilities as follows:June 2024;Article 1. Supplement Point d to Clause 2, Article 2 as follows:i "d) Medical oxygen." lArticle 2. Supplement Clause 6 and Clause 7 to Article 3 as follows:itself;

Pursuant to DecreeNo. 63/2012/ND-CP dated August 31June 2024;A medicine production facility that meets EU-GMP or PIC/s-GMP standards, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CP based on Decree No. 24/2014/ND-CP dated April 4, 2014 issued by the Governmentpolicies;

is a medicine production facility certified by the competent authority of a country participating in the EMA or ICH or PIC/s to meet EU-GMP or PIC/s-GMP standards or equivalent, and announced by the Ministry of Health (Drug Administration Department) on the Drug Administration Department's electronic information website.

Countries participating in ICHNo. include countries belonging to the EU, Japan, the United States, and observer countries and associated members of ICH members, announced by the Ministry of Health (Drug Administration Department) according to the updated list of ICH."Deputy ministers of ministerial-level agencies,Article 3. Amend and supplement Clause 1 and Clause 3 of Article 7 as follows:FUNCTIONS, DUTIES, POWERS, ORGANIZATIONAL STRUCTURE, OPERATIONAL REGULATIONS, AND RELATIONSHIPS OF MANAGEMENT BOARDS; DUTIES, POWERS OF THE CHAIRPERSON, VICE CHAIRPERSON (IF ANY), SECRETARY, AND MEMBERS OF MANAGEMENT BOARDSFor power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract. on Bidding "1. Generic drug tender package.

A generic drug tender package may contain one or more generic drugs. Each generic drug is divided into groups based on technical criteria and technology standards approved as follows:

- Drugs produced at a production facility meeting EU-GMP or PIC/s-GMP standards in a country participating in ICH;

- Drugs produced at a production facility meeting WHO-GMP standards certified by the Ministry of Health of Vietnam (Drug Administration Department) and approved for circulation by the competent authority of a country participating in ICH;

"6. - Drugs produced at a production facility meeting EU-GMP or PIC/s-GMP standards but not in a country participating in ICH; - Drugs licensed from a production facility meeting EU-GMP or PIC/s-GMP standards in countries participating in ICH and produced at a production facility meeting WHO-GMP standards certified by the Ministry of Health of Vietnam (Drug Administration Department).

7. c) Group 3: Drugs produced at a production facility meeting WHO-GMP standards certified by the Ministry of Health of Vietnam (Drug Administration Department). d) Group 4: Drugs with proven bioequivalence announced by the Ministry of Health.

đ) Group 5: Drugs not meeting the classification criteria specified in Points a, b, c, and d of Clause 1 of this Article."

"3. Traditional medicine and herbal medicine tender package.

A traditional medicine and herbal medicine tender package is divided into groups based on technical criteria and technology standards approved as follows:

a) Group 1:

a) Group 1: Traditional medicine and herbal medicine produced at a facility meeting WHO-GMP standards certified by the Ministry of Health of Vietnam (Drug Administration Department).

b) Group 2: Traditional medicine and herbal medicine produced at a facility not yet certified by the Ministry of Health of Vietnam (Drug Administration Department) to meet WHO-GMP standards."

b) Group 2:

- Medicines produced at manufacturing facilities that meet EU-GMP or PIC/s-GMP standards but are not from countries participating in ICH;

- Medicines under license from manufacturing facilities that meet EU-GMP or PIC/s-GMP standards in countries participating in ICH and are produced at manufacturing facilities certified to meet WHO-GMP standards by the Ministry of Health of Vietnam (Medicine Administration Department);

c) Group 3: Medicines produced at manufacturing facilities that meet WHO-GMP standards and are certified by the Ministry of Health of Vietnam (Medicine Administration Department).

d) Group 4: Medicines proven to be bioequivalent as announced by the Ministry of Health.

đ) Group 5: Medicines that do not meet the criteria for classification specified in Point a, b, c, and d of Clause 1 of this Article.

"3. Tender package for traditional medicine and herbal medicines.

The tender package for traditional medicine and herbal medicines is divided into groups based on technical and technological criteria permitted as follows:

a) Group 1: Traditional medicine and herbal medicines produced at facilities that meet WHO-GMP standards certified by the Ministry of Health of Vietnam (Medicine Administration Department).

b) Group 2: Traditional medicine and herbal medicines produced at facilities that have not been certified to meet WHO-GMP standards by the Ministry of Health of Vietnam (Medicine Administration Department)."

Article 4. Amend Point b and Point c Clause 1 Article 8 as follows:

"b) For tenders for branded drugs by name, the tender content shall include: drug name, active ingredient name, concentration or content, dosage form, unit of measurement, quantity, planned price including value added tax and must be accompanied by the phrase "or equivalent treatment". In cases where one active ingredient has multiple branded drug names published in the list of original branded drugs or rare drugs by the Ministry of Health, the drug name item must record all branded drug names along with the phrase "or equivalent treatment". Example: Branded Drug Name A or Branded Drug Name B or equivalent treatment."

"c) For traditional medicine and herbal medicine tenders, the tender content shall include drug name, dosage form, unit of measurement, quantity, planned price including value added tax. The recording of drug names in traditional medicine and herbal medicine tenders shall be carried out as follows:

- Only record the components of the drug, not the trade name;

- In cases where drugs have the same components and the same dosage form: Only record the concentration or content of the drug component when differences in concentration or content lead to differences in dosage and treatment indications. The Pharmacy and Treatment Council of healthcare facilities shall be responsible for deciding on the recording of drug concentrations or contents in traditional medicine and herbal medicine tenders to ensure competitive and fair conditions among such tenders."

Article 5. Amend and supplement Clause 2 and Clause 3 Article 16 as follows:

"2. For tenders for generic drugs and traditional medicine and herbal medicine: Each group of drugs may only be awarded to one drug that meets technical and quality requirements specified in the tender documentation and has the lowest evaluated price within that group of drugs."

"3. For tenders for branded drugs by name: Each drug may only be awarded to one drug that meets technical and quality requirements specified in the tender documentation and has the lowest evaluated price within the tender."

Article 6. Amend and supplement Point d Clause 1 Article 23 as follows:

"d) Drugs listed in the procurement plan approved but whose annual usage exceeds the approved quantity. The quantity of each drug purchased beyond the plan in a year shall not exceed 20% of the quantity of that drug that was awarded. The total value of drugs purchased beyond the plan in this case for the unit shall not exceed two billion dong per year."

Article 7. Amend and supplement Clause 1 and Clause 4 Article 26 as follows:

"1. The Ministry of Health shall be responsible for publishing and updating the list of countries participating in EMA, ICH, PIC/s; the list of pharmaceutical production facilities meeting EU-GMP, PIC/s-GMP standards; the list of pharmaceutical production facilities meeting WHO-GMP standards certified by the Ministry of Health of Vietnam (Drug Administration Department); the list of original branded drugs, drugs equivalent to original branded drugs, and drugs with bioequivalence documentation; the list of drugs licensed for sale from production facilities meeting EU-GMP or PIC/s-GMP standards in ICH-participating countries and produced at facilities certified by the Ministry of Health of Vietnam (Drug Administration Department) to meet WHO-GMP standards; the list of drugs produced at facilities meeting WHO-GMP standards certified by the Ministry of Health of Vietnam (Drug Administration Department) and authorized for sale by competent authorities in ICH-participating countries."

"4. Social Insurance agencies shall be responsible for appointing staff to participate in the evaluation committee for procurement plans, tender documentation preparation teams, tender evaluation committees, and result verification committees for tenders purchasing drugs from the health insurance fund according to the classification of the General Director of the Vietnam Social Insurance."

Article 8. Effective Date:

1. This Circular takes effect from January 1, 2014.

2. Clauses 1, Clause 3 Article 7; Points b, c Clause 1 Article 8; Clause 2, Clause 3 Article 16; Point d Clause 1 Article 23; Clause 1, Clause 4 Article 26 of Circular Joint No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Ministry of Health and the Ministry of Finance guiding the tender purchase of medicines in medical facilities shall cease to be effective from the date this Circular takes effect.

3. For tenders that have submitted procurement plans before the date this Circular takes effect, they shall continue to be implemented according to the provisions of Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Ministry of Health and the Ministry of Finance guiding the tender purchase of medicines in medical facilities.

Article 9. Implementation organization:

The Chairman of the People's Committee of provinces and centrally governed cities; the Directors of Health Departments of provinces and centrally governed cities; the Directors of healthcare facilities and Heads of related units shall be responsible for implementing this Circular./.