The Ministry of Health issued Circular 07/2024/TT-BYT regulating drug bidding at public health facilities.

Accordingly, the Circular regulates drug bidding activities using state budget capital, health insurance funds and other legal revenue sources of state administrative agencies on health and public health service units (public health facilities), including: 1- Division of bidding packages and drug groups; 2- Process and procedures for selecting drug suppliers; 3- Centralized drug procurement.

This Circular applies to bidding for pharmaceutical chemicals, radioactive drugs, markers, vaccines, biological products, herbal medicines, traditional medicines, medicinal herbs, traditional medicinal ingredients and gases that are granted circulation registration numbers as drugs to serve medical examination and treatment.

The Circular clearly states that the purchase of drugs ordered or assigned by the State shall comply with the provisions of Decree No. 32/2019/ND-CP dated April 10, 2019 of the Government regulating the assignment, ordering or bidding for the provision of public products and services using the State budget from regular expenditure sources.

The purchase of drugs used in medical examination and treatment at military medical agencies, medical agencies, and medical facilities in detention facilities of the armed forces shall comply with the instructions of the Ministry of National Defense and the Ministry of Public Security.

Illustration

The purchase of whole blood and qualified blood products is carried out in accordance with the provisions of Circular No. 15/2023/TT-BYT dated July 20, 2023 of the Minister of Health stipulating the maximum price and costs for determining the price of a unit of whole blood and qualified blood products.

Responsibility for planning contractor selection and organizing contractor selection

Regarding the responsibility for planning contractor selection and organizing contractor selection, the Circular clearly states that the national centralized procurement unit is responsible for planning contractor selection and organizing contractor selection according to the provisions in Chapter IV of this Circular. The time for implementing the framework agreement and the maximum time for implementing the bidding package is 36 months, divided by drug group and the supply schedule by quarter and year for drugs in one of the following cases:

- Medicines on the national centralized procurement list issued by the Minister of Health and meeting technical criteria of groups 1 and 2 as prescribed in Article 4 of this Circular;

- Medicines on the list of rare medicines issued by the Minister of Health;

- Medicines must be purchased in small quantities to ensure sufficient medicine to meet the needs of medical examination and treatment as prescribed in Clause 1, Article 53 of the Law on Bidding.

According to the Circular, the local centralized procurement unit is responsible for planning contractor selection and organizing contractor selection according to the provisions of Chapter IV of this Circular. The time for implementing the framework agreement and the maximum time for implementing the bidding package is 36 months, divided by drug group and the supply schedule by quarter and year for drugs in one of the following cases:

- Drugs on the list of local centralized procurement, except for drugs on the list of national centralized procurement issued by the Minister of Health and meeting the technical criteria of groups 1 and 2 as prescribed in Article 4 of this Circular;

- Medicines on the list of rare medicines issued by the Minister of Health;

- Medicines must be purchased in small quantities to ensure sufficient medicine to meet the needs of medical examination and treatment as prescribed in Clause 1, Article 53 of the Law on Bidding.

According to the Circular, the procurement of drugs as prescribed in Clause 5, Article 53 of the Law on Bidding is implemented as follows:

Clause 5, Article 53 of the Law on Bidding clearly states:

5. For goods and services not included in the list of centralized procurement but many agencies, organizations and units have a need to purchase the same type of goods and services, they can be combined into one bidding package for one of the agencies, organizations and units to purchase or for the unit with centralized procurement function to carry out the procurement.

- In case agencies, organizations, units (hereinafter referred to as units) have an agreement on unifying a unit to be the focal point for purchasing, that unit shall synthesize the needs of the remaining units in the agreement and carry out the purchasing in accordance with the provisions of the law on bidding. The agreement must be expressed in writing and must include the contents of the responsibility for preparing and submitting the purchasing needs and the responsibility for paying the costs.

- In case the units do not have an agreement and cannot organize the contractor selection themselves or have organized the contractor selection but failed, they shall send the drug procurement request to the management agency: Ministry of Health for units under the management of the Ministry of Health or in case there are 02 or more provinces making requests; Ministry of National Defense for units under the management of the Ministry of National Defense; Ministry of Public Security for units under the management of the Ministry of Public Security; Department of Health for units in the area and not under the management authority of the Ministry of Health, Ministry of National Defense and Ministry of Public Security.

After receiving the request from the unit, within 10 days, the management agency is responsible for designating the unit to carry out the purchase. In case of non-designation, a written response must be sent to the unit stating the reason.

The Ministry of Health clearly stated that public health facilities are responsible for planning contractor selection and organizing contractor selection for drugs not planned for and organized by the National Centralized Procurement Unit and the Local Centralized Procurement Unit.

The planning for contractor selection and organization of contractor selection at public health facilities shall comply with the provisions of Chapter III of this Circular. The maximum implementation period of the bidding package is 36 months, divided into each bidding package and drug group.

Report on the implementation of the results of the national centralized contractor selection

The Circular clearly states that before the 10th of each month and the 10th of the first month of each quarter or on an ad hoc basis upon request, contractors shall report on the implementation of contracts for the supply of drugs on the List of drugs for centralized bidding at the national level according to the form specified in Appendix VII issued with this Circular and send them to the National Centralized Procurement Unit and the Department of HIV/AIDS Prevention and Control for anti-HIV drugs.

Before the 10th day of the first month of each quarter or upon request, medical facilities managed by localities, medical facilities managed by ministries and branches in the area shall send reports on the implementation of contracts for the supply of drugs on the List of drugs subject to centralized bidding at the national level according to the form specified in Appendix VII issued with this Circular to the local centralized procurement unit and the provincial HIV/AIDS prevention and control focal point for anti-HIV drugs.

Before the 15th of the first month of each quarter or upon request, the local centralized procurement unit and medical facilities under the management of the Ministry of Health shall report on the implementation of contracts for the supply of drugs on the List of drugs subject to centralized bidding at the national level according to the form specified in Appendix VII issued with this Circular and send them to the national centralized procurement unit and the Department of HIV/AIDS Prevention and Control for anti-HIV drugs.

Report on the implementation of local-level centralized contractor selection results

According to the Circular, before the 10th day of the first month of each quarter or upon request, the contractor shall report on the implementation of the contract for supplying drugs on the List of drugs for centralized bidding at the local level according to the form specified in Appendix VII issued with this Circular and send it to the Centralized Procurement Unit at the local level.

Before the 10th day of the first month of each quarter or upon request, public health facilities under local management shall report on the implementation of contracts for the supply of drugs on the List of drugs subject to centralized bidding at the local level according to the form specified in Appendix VII issued with this Circular and send it to the Local Centralized Procurement Unit.

Must clearly announce the drug lists for contractor selection

The Circular clearly states that heads of central agencies direct public health facilities under their management to select drug suppliers in accordance with the provisions of this Circular and legal provisions on contractor selection.

The Minister of Health shall delegate the authority to decide on drug procurement to agencies and units directly using capital sources under the management of the Ministry of Health to purchase drugs to serve the operations of those agencies and units and to serve the tasks assigned by the Minister of Health.

The Ministry of Health requests the Department of Drug Administration and the Department of Traditional Medicine and Pharmacy to be responsible for updating and publishing on the website the following information:

List for contractor selection, including:

- List of drug regulatory agencies of countries on the SRA or EMA list and list of countries on the SRA or EMA list;

- List of drug regulatory agencies of countries that are members of PIC/s and ICH;

- List of drug manufacturing facilities in Vietnam assessed by the Vietnamese drug administration agency to meet WHO-GMP principles and standards;

- List of drug manufacturing facilities meeting EU-GMP principles and standards or drug manufacturing facilities meeting EU-GMP principles and standards; List of manufacturing facilities meeting PIC/s-GMP principles and standards; List of manufacturing facilities meeting WHO-GMP principles and standards;

- List of manufacturing facilities assessed by the Vietnamese Ministry of Health to meet GMP principles and standards for herbal medicines or traditional medicines;

- List of drug manufacturing facilities in Vietnam assessed by the Vietnamese Ministry of Health as meeting GMP principles and standards for medicinal herbs and traditional medicines;

- List of pharmaceutical manufacturing facilities in Vietnam assessed by the Vietnamese Ministry of Health as meeting GMP principles and standards for pharmaceutical ingredients from medicinal herbs.

List of drugs used for contractor selection, including:

- List of medicines, traditional medicines, and semi-finished medicinal products granted circulation registration or import license;

- List of original brand name drugs and reference biological products;

- List of original pharmaceutical drugs and reference biological products for processing and technology transfer in Vietnam;

- List of drugs with proven bioequivalence;

- List of drugs manufactured entirely on production lines in Vietnam that meet the criteria of group 1 specified in Point c, Clause 1, Article 4 of this Circular;

- List of traditional medicines in the following dosage forms: extract, granule, powder, liquid extract, essential oil, resin, gum, jelly ensuring quality according to the regulations of the Ministry of Health on quality management of medicinal herbs and traditional medicines;

- List of drugs in the National Product List;

- List of drugs awarded "Vietnamese Medicine Star" by the Ministry of Health;

- List of medicinal herbs grown, harvested or naturally exploited by the facility assessed by the Vietnamese Ministry of Health to meet GACP principles and standards;

- List of processed drugs (without technology transfer for drug production);

- List of processed drugs (with transfer of drug production technology); List of technology transferred drugs granted or with extended circulation registration certificates;

- List of drugs manufactured from raw materials (pharmaceutical substances) manufactured in countries on the SRA or EMA list, raw materials (pharmaceutical substances) granted CEP certificate;

- List of drugs and manufacturing facilities, suppliers with violations of drug quality;

In addition, the Drug Administration must publish a list of drug manufacturing facilities and suppliers that meet the requirements on capacity, experience and reputation as a basis for inviting participation in limited bidding./.

Ministry of Health Portal

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