Chapter I
GENERAL PROVISIONS
Article 1. Scope
1. This Circular provides guidance on bidding for supply of drugs (modern medicines, herbal medicines, traditional medicines, vaccines and biological medical products) and herbal ingredients for public health facilities, including: the division of contract packages and drug groups; prepares plans, forms, methods and organizes selection of drug suppliers; provides guidance on centralized procurement and price negotiation using state capital, health insurance fund, proceeds from medical examination and treatment services and other lawful sources of income of public health facilities.
2. The procurement of drugs by drug retailers within the premises of public health facilities shall comply with the provisions specified in Clause 76, Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 amending a number of provisions on business investment conditions under the state management scope of the Ministry of Health. In case the health facility organizes the bidding for supply of drugs for the drug retailers within their premises, the guidance in this Circular shall be applied.
3. The procurement of medicines under orders and plans of the State shall follow the Decree No. 32/2019/ND-CP dated April 10, 2019 on task assignment, ordering or bidding for supplying products and public services using state budget sources.
4. The procurement of medicines for use in military health facilities shall comply with the guidance of the Ministry of Defense and the Ministry of Public Security.
5. The procurement of medical oxygen, nitrite oxide (NO) and in vitro diagnostic reagents shall comply with the Circular No. 58/2016/TT-BTC dated March 29, 2016 of the Minister of Finance on using state capital to procure and maintain regular operation of regulatory authorities, units of the people's armed forces, public service providers, political organizations, socio-political organizations, socio-political-professional organizations, social organizations, socio-professional organizations.
6. The procurement of whole blood, qualified blood preparations shall comply with Circular No. 05/2017/TT-BYT of April 14, 2017 of the Minister of Health on maximum prices and cost of pricing a unit of whole blood or blood qualified preparation, and Circular No. 20/2018/TT-BYT dated August 30, 2018 of the Minister of Health amending some articles of the Ministry's Circular No. 05/2017/TT-BYT dated April 14, 2017 on maximum prices and cost of pricing a unit of whole blood or blood qualified preparation.
7. With regard to the antiretroviral drugs (ARVs) funded by health insurance fund, the formulation and appraisal and approval for the plan and organization of contractor selection as well as the signing of framework agreement with selected contractors shall comply with the provisions of this Circular.
Other contents relating to preparation of demand plans; signing contract with suppliers; management of use, advance, payment for ARVs; regulations, funding sources and methods of cost support as well as payment for ARVs to HIV-infected people with health insurance cards shall comply with Circular No. 28/2017/TT-BYT dated June 28, 2017 of the Ministry of Health on management of ARVs funded by health insurance fund and cost support as well as payment for ARVs to HIV-infected people with health insurance cards and Circular No. 08/2018/TT-BYT dated April 18, 2018 amending a number of articles of Circular No. 28/2017/TT-BYT dated June 28, 2017 on management of ARVs funded by health insurance fund and cost support as well as payment for ARVs to HIV-infected people with health insurance cards.
Article 2. Regulated entities
1. This Circular applies to organizations and individuals participating or involved in bidding for supply of drugs.
2. State-invested health facilities operated under Law on Enterprises shall follow the provisions of this Circular.
3. Private health facilities participating in provision of medical examination and treatment services covered by health insurance shall follow Article 52 of Law on Bidding and the provisions of Clause 7, Article 50 of this Circular.
Article 3. Definitions
For the purposes of this Circular; the terms below shall be construed as follows:
1. SRA (Stringent Regulatory Authorities) refers to drug administration specified in Clause 10 Article 2 of Circular No. 32/2018/TT-BYT dated November 12, 2018 on marketing authorization of drugs and medicinal ingredients.
2. Reference authority refers to drug administration specified in Clause 9 Article 2 of Circular No. 32/2018/TT-BYT dated November 12, 2018 on marketing authorization of drugs and medicinal ingredients.
3. ICH (International Conference on Harmonization) stands for the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
4. PIC/s (Pharmaceutical Inspection Co-operation Scheme) stands for Pharmaceutical Inspection Co-operation Scheme.
5. GMP requirements refer to good manufacturing practices for pharmaceutical products.
6. GACP requirements refer to good agricultural and collection practices for herbal ingredients.
7. A drug manufacturing line fulfilling EU-GMP requirements refers to a drug manufacturing line granted EU-GMP certificate by a competent authority of a country that is a member state of EMA (European Medicines Agency).
8. A drug manufacturing line fulfilling the requirements equivalent to EU-GMP refers to a drug manufacturing line granted GMP certificate by a competent authority of a country that is considered SRA.
9. A drug manufacturing line satisfying PIC/s-GMP requirements refers to a drug manufacturing line granted PIC/s-GMP certificate by a competent authority of a country that is a participant in PIC/s.
10. CIF price is an import price that includes the cost, insurance and freight from the exporting country to the Vietnamese port.
11. Reference biological means a biological granted certificates of marketing authorization in Vietnam on the basis of sufficient data about its quality, safety and efficacy.
12. Pharmaceutical equivalence means drugs containing the same active ingredient and concentration in the same dosage form, having the same route of administration and reaching the same quality standards.
13. Therapeutic equivalence means a drug having equivalent content and proved bioequivalence and having clinical efficacy and safety when using it on patients under specific conditions according to the instructions for use of drugs.
Article 4. Responsibility for planning and organizing selection of drug supplier (hereinafter referred to as “contractor”)
1. Heads of health facilities shall organize and develop the contractor selection plan specified in Article 14 of this Circular and the following provisions:
a) For drugs on the national list of drugs for centralized bidding procurement, list of drugs for procurement by price negotiation: National centralized drug procurement center shall develop the contractor selection plan.
The plan shall be based on the demand for drugs of health facilities according to the notification of the national centralized drug procurement center. The implementation time is up to 36 months, categorized by drug category and supply interval (quarterly, annually);
a) For drugs on the local lists of drugs for centralized bidding procurement: the local centralized drug procurement units shall develop the contractor selection plan. The plan is based on the demand for drugs of health facilities according to the notification of the local centralized drug procurement units. The implementation time is up to 36 months, categorized by drug category and supply interval (quarterly, annually);
c) For contractor selection carried out by health facilities, the health facilities shall develop their own contractor selection plans. The plan is made periodically or on request. The implementation time is up to 12 months or on request, categorized by drug category.
2. Heads of health facilities shall organize the contractor selection plan and ensure the following regulations:
a) For drugs on the national list of drugs for centralized bidding procurement, list of drugs for procurement by price negotiation: national centralized drug procurement center shall organize the contractor selection plan specified in Chapter IV and Chapter V of this Circular;
a) For drugs on the Local lists of drugs for centralized bidding procurement: the local centralized drug procurement units shall organize the contractor selection plan specified in Chapter IV of this Circular;
a) For drugs that are not on the national list of drugs for centralized bidding procurement, local lists of drugs for centralized bidding procurement, List of drugs for procurement by price negotiation: The health facility shall organize the contractor selection plan specified in Chapter III of this Circular;
Article 5. Reporting bidding results
1. Within 10 days from the day on which the contractor selection result is approved, Heads of health facilities shall report the contractor selection result as below:
a) Hospitals and institutions providing inpatient treatment affiliated to the Ministry of Health shall send their contractor selection results to the Ministry of Health.
b) Local centralized drug procurement units, health facilities offering bidding for supply of drugs under management of People's Committees of provinces and central-affiliated cities (hereinafter refer to as “provinces”) shall send contractor selection results to Provincial Departments of Health of provinces.
c) Health facilities of other sectors and other health facilities shall send contractor selection results to competent authorities for approval.
2. Within up to 10 days from the day on which the contractor selection results are received from the units specified in Point b Clause 1 of this Article, Provincial Departments of Health of provinces shall send a consolidated report to the Ministry of Health.
3. Forms of report submission:
a) Report forms shall comply with Appendix 1 and Appendix 2 enclosed herewith;
b) Reports shall be sent by post and email to the Ministry of Health as follows:
- 01 copy shall be sent to Department of Finance – Planning (Ministry of Health) at: dauthau.khtc@moh.gov.vn for all procurements.
- 01 copy shall be sent to Drug Administration (Ministry of Health) at: qlgiathuoc.qld@moh.gov.vn for procurements of generic drugs, proprietary drugs or equivalent drugs.
- 01 copy shall be sent to Traditional Medicine Administration (Ministry of Health) at: quanlyduoclieu@moh.gov.vn for procurements of traditional drugs, herbal drugs, herbal ingredients and traditional ingredients.
4. Before the 31st of October every year, health authorities, hospitals and institutions providing inpatient treatment affiliated to the Ministry of Health and; Provincial Departments of Health of provinces and central-affiliated cities shall prepare and send reports on violations committed by contractors during bidding for supply of drugs by local health facilities in the previous period as specified in Appendix 3 enclosed herewith to the Ministry of Health (Department of Planning - Finance for all contract packages; Drug Administration for contract packages of generic drugs, proprietary drugs or equivalent drugs; Traditional Medicine Administration for contract packages of herbal drugs, traditional drugs, herbal ingredients and traditional ingredients). The reports shall be the basis for contractor evaluation in the next period.
Article 6. Expenses and document retention during contractor selection
1. Expenses incurred during the process of contractor selection shall comply with Article 9 of Decree No. 63/2014/ND-CP dated June 26, 2014 on detailed guidelines for some articles on contractor selection of Law on Bidding (hereinafter referred to as Decree No. 63/2014/ND-CP).
2. Retention of documents during the process of contractor selection shall comply with Article 10 of Decree No. 63/2014/ND-CP.
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