Thông tư 37/2013/TT-BYT

CIRCULAR

GUIDING THE ELABORATION OF BIDDING DOSSIER FOR MEDICINE PURCHASE IN MEDICAL ESTABLISHMENTS

Pursuant to the Pharmacy Law No. 34/2005/QH11 dated June 14, 2005;

Pursuant to the Law on tendering No. 61/2005/QH11 dated November 29, 2005; Law amending and supplementing a number of articles of the laws concerning capital construction investment No. 38/2009/QH12 dated June 19, 2009;

Pursuant to the Government’s Decree No. 79/2006/ND-CP dated August 09, 2006, detailing implementation of a number of Articles of the Pharmacy Law; Government’s Decree No. 89/2012/ND-CP dated October 24, 2012, amending and supplementing a number of Articles of Government’s Decree No. 79/2006/ND-CP dated August 09, 2006, detailing implementation of a number of Articles of the Pharmacy Law;

Pursuant to the Government’s Decree No. 85/2009/ND-CP dated October 15, 2009, guiding implementation of Law on tendering and selection of the building contractors under construction law;

Pursuant to Government’s Decree No. 63/2012/ND-CP dated August 31, 2012, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Minister of Health and the Minister of Finance guiding the bidding for medicine purchase by medical establishments; the Joint Circular No. 36/2013/TTLT-BYT-BTC dated November 12, 2013, of the Minister of Health and the Minister of Finance amending and supplementing a numbers of Articles of the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Minister of Health and the Minister of Finance guiding the bidding for medicine purchase by medical establishments;

Pursuant to the Circular No. 05/2010/TT-BKH dated February 10, 2010 of the Minister of Planning and Investment detailing the elaboration of bidding dossier for goods procurement;

The Minister of Health promulgates Circular guiding the elaboration of bidding dossier for medicine purchase in medical establishments as follows:

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Circular guiding the elaboration of bidding dossier when conduct the domestic open bidding, limited bidding for medicine purchase in serve of prevention of disease, medical examination and treatment from state budget, fund of medical insurance and other lawful revenues in medical establishments (hereinafter collectively referred to as units).

2. For bidding packages for medicine purchase of projected used ODA funding, if donors agree, this Circular may be applied or some content may be amended and supplemented under regulations on bidding in International treaties in which the Socialist Republic of Vietnam is a contracting party or international agreement which competent agencies or organizations of the Socialist Republic of Vietnam have been concluded in.

3. This Circular does not apply in the following cases:

a) Medicines under orders of state and paid with the state budget source;

b) materia medica and traditional medicines;

c) Blood and blood products;

d) Medical oxygen.

Article 2. Subjects of application

This Circular applies to organizations and individuals responsible for the elaboration of bidding dossier for medicine purchase in units using funding source from state budget, fund of medical insurance and other lawful revenues in order to purchase medicines in serve of prevention of disease, medical examination and treatment.

Article 3. Principles in elaboration of bidding dossier for medicine purchase

The elaboration of bidding dossier for medicine purchase in units shall comply with the Circular No. 05/2010/TT-BKH dated February 10, 2010 of the Minister of Planning and Investment detailing the elaboration of bidding dossier for goods procurement (hereinafter abbreviated to Circular No. 05/2010/TT-BKH) the detailed guides in this Circular and other relevant legal documents.

Chapter II

DETAILING SOME CONTENTS IN THE ELABORATION OF BIDDING DOSSIER FOR MEDICINE PURCHASE

Article 4. Conditions for participation in bidding of contractors

Apart from the satisfaction of provisions in section 2 Chapter I the first part of model bidding dossier for goods procurement promulgated together with Circular No. 05/2010/TT-BKH contractors must satisfy the following conditions:

1. Contractors must register for participation in bidding package appropriate with the division of bidding packages specified in Article 7 of the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Minister of Health and the Minister of Finance guiding the bidding for medicine purchase by medical establishments (hereinafter abbreviated to the Joint Circular No. 01/2012/TTLT-BYT-BTC); and Article 3 of the Joint Circular No. 36/2013/TTLT-BYT-BTC dated November 12, 2013, of the Minister of Health and the Minister of Finance amending and supplementing a numbers of Articles of the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012, of the Minister of Health and the Minister of Finance guiding the bidding for medicine purchase by medical establishments (hereinafter abbreviated to the Joint Circular No. 36/2013/TTLT-BYT-BTC).

2. For bidding packages for medicines under generic name, contractors may participate in one or many medicine group if they satisfy criteria of such medicine group as defined in article 3 of the Joint Circular No. 36/2013/TTLT-BYT-BTC specified as follows:

a) Contractors that have medicines satisfying criteria at Group 1 are entitled to participate in bidding of Group 1, Group 2 and Group 5;

b) Contractors that have medicines satisfying criteria at Group 2 are entitled to participate in bidding of Group 2 and Group 5;

c) Contractors that have medicines satisfying criteria at Group 3 are entitled to participate in bidding of Group 3 and Group 5;

d) Contractors that have medicines satisfying criteria at Group 4 are entitled to participate in bidding of Group 4 and/or other Group if they also meet criteria of such group;

dd) Contractors that have medicines failing to meet criteria of Groups 1, 2, 3, 4 are entitled to participate in bidding of Group 5.

3. For bidding package of oriental medicines, medicines from materia medica”

a) Contractors that have medicines satisfying criteria at Group 1 are entitled to participate in bidding of Group 1, Group 2;

b) Contractors that have medicines satisfying criteria at Group 2 are entitled to participate in bidding of Group 2 only.

4. If there are many establishments participating in manufacture progress of a drug wish to participate in bidding, all such establishments must also satisfy criteria of such group.

Article 5. Provisions on content of bid dossier

Apart from implementation under provisions in section 8 Chapter I the first part of model bidding dossier for goods procurement promulgated together with Circular No. 05/2010/TT-BKH bid dossier must implement some contents specified as follows:

1. Documents, information to prove eligibility, capability and experiences of contractor:

a) Certificate of eligibility for medicine business:

In the business scope must clearly state medicine manufacture or medicine wholesale.

b) Good practice certificate depending on each business form:

- GSP (Good storage practices): For establishments directly importing medicines.

- GDP (Good distribution practices): For establishments of medicine wholesale.

- GACP (Good agricultural and collection practices): For materia medica agricultural establishments.

- GMP (Good manufacturing practices): For establishments of medicine manufacture.

c) Documents to prove capability and experiences of contractor (contracts in performance course and similar contracts performed by contractor; capability and experiences of contractor in domain of manufacture, business; financial capability of contractor):

To comply with provisions in forms No. 8, 9, 10 and 12 Chapter IV of model bidding dossier for goods procurement promulgated together with the Circular No. 05/2010/TT-BKH.

2. Documents, information to prove the legality and eligibility of item of drug used in bidding participation:

a) Information of name of medicines user in bidding participation, circulation registration number or number of import permit for medicines which have not yet had registration number granted by the Drug Administration of Vietnam and other relevant information:

Contractor writes fully information as prescribed at Annex 1 promulgated together with this Circular. Information must be appropriate with information of medicines granted registration number or import permit as announced by the Drug Administration of Vietnam on its website (address: http://www.dav.gov.vn);

b) Written commitment on satisfying requirements made by unit involving the progress and supply scope for evaluation as prescribed at section 4 Annex 2 promulgated together with this Circular.

c) Written commitment of contractor for the remaining use time limit of medicines selected to win bidding as from supplying medicine to medical establishments, which is not less than 06 months for medicines with use time limit of 02 years or more; 03 months for medicines with use time limit of 01-02 years; ¼ of use time limit for medicines with use time limit of less than 01 year.

3. Other contents:

Contractor need supply the following documents (if any):

a) Notice of bid winner or invoice of medicine sale or contract of medicine supply for medical establishments or other documents to prove experiences in medicine supply for evaluation as prescribed at section 10 Annex 3 promulgated together with this Circular;

b) Certificate of dossier of announcing on organization of GPP medicine store chains by enterprise, certificate of medicine distribution center for evaluation as prescribed at sections 13 and 14 Annex 3 promulgated together with this Circular;

c) Documents clearly state the origin of materia medica for oriental medicines, medicines from materia medica (valid invoices, vouchers of purchasing materia medica from providers that have been granted certificate of manufacture and business in medicines from materia medica by the Ministry of Health or the provincial Services of Health; the receipt of announcement on materia medica produced under WHO-GACP of manufacturers of materia medica) for evaluation as prescribed at section 8 Annex 3 promulgated together with this Circular;

d) Valid invoices and vouchers of purchasing antibiotics, raw materials produced domestically for manufacture of medicines used in bid participation for evaluation as prescribed at section 7 Annex 3 promulgated together with this Circular.

4. Documents supplied by contractor when participating in bid are copies with seal for confirmation of contractor. Especially for certificate of satisfying GMP standard, contractor is required only write its information as prescribed at section 1 Annex 3 promulgated together with this Circular (information of certificate of satisfying GMP standard must be appropriate with information announced by the Drug Administration of Vietnam on its website (address: http://www.dav.gov.vn).

Article 6. Prerequisites to remove bidding dossiers

Apart from implementation under provisions at Clause 2 section 24 Chapter I and Clause 2 section 24 Chapter II the first part of model bidding dossier for goods procurement promulgated together with Circular No. 05/2010/TT-BKH prerequisites to remove bid dossier are specified as follows:

1. Bid dossier of a contractor is removed in cases:

a) Contractor fails to have certificate of eligibility for medicine business granted by competent agencies (in case of lack of such certificate in bid dossier, the bid solicitor may require contractor for supplementation under regulations).

b) Certificate of eligibility for medicine business has no content of medicine manufacture or medicine wholesale in its business scope.

2. Item of drug used in bid participation is removed in cases:

a) Item of drug used in bid participation or medicine group is not appropriate with article 4 of this Circular.

b) Item of drug used in bid participation is not permitted to circulate legally in Vietnam (banned producing for medicines produced domestically or banned import for foreign medicines in the effective time limit of the circulation registration number or import permit).

c) Item of drug used in bid participation is withdrawn registration number in the effective time limit of registration number as prescribed in Article 33 Chapter IV of Circular No. 22/2009/TT-BYT dated November 24, 2009 of Minister of Health providing for the medicine registration.

a) All products of item of drug used in bid participation are suspended for circulation, recalled as prescribed in Clause 1 Article 13 Chapter IV of Circular No. 09/2010/TT-BYT dated April 28, 2010 of Minister of Health guiding management of medicine quality.

dd) In bid dossier, item of drug has unfixed price, is offered at various prices (unless contractor participate in bid with many items of drug with the same name of active ingredient, concentration, content, dosage form of different manufacturers).

e) Contractor supplies information and enclosed documents of items of drug used in bid participation dishonestly (supply of wrong information in comparison with dossier of medicine registration, dossier of declaring medicine price, certificates granted by the provincial Services of Health, the Ministry of Health falsifying result of contractor selection).

Article 7. Criteria for evaluation and content to define the evaluation price

To comply with Chapter III the first part of model bidding dossier for goods procurement promulgated together with Circular No. 05/2010/TT-BKH and some specific contents are implemented as follows:

1. Criteria for evaluation on capability and experiences of contractor:

a) Criteria for evaluation on capability and experiences of contractor include criteria specified in Annex 2 promulgated together with this Circular.

b) Method of evaluation: Under criterion of "pass", “fail”, specified:

- Contractor passing all criteria specified in Annex 2 promulgated together with this Circular is evaluated as satisfying requirements on capability and experiences.

- Criteria specified in Annex 2 promulgated together with this Circular are evaluated as “pass” if all detailed criteria in each criterion of requirement are evaluated as “pass”.

2. Criteria for technical evaluation:

a) Criteria for technical evaluation include criteria specified in Annex 3 promulgated together with this Circular.

b) Method of evaluation: Under method of scoring points (point scale of 100), specified:

- In each item specified in Annex 3 promulgated together with this Circular, a contractor passing concurrently two criteria or more only is calculated for point of criterion having highest point.

- The required minimum point level in technical aspect is defined under nature of each bidding package or item of goods in bidding plan already been approved by competent persons but must not be lower than 70 point.

- Bid dossier with total passing points equal to or exceeding the required minimum point level in technical aspect will be evaluated as satisfying technical requirements.

c) For the small-sized bidding packages for medicine purchase (specified at Clause 1 Article 33 of the Government’s Decree No. 85/2009/ND-CP dated October 15, 2009, guiding implementation of Law on tendering and selection of the building contractors under construction law):

To apply evaluation under criterion of “pass” or “fail” based on contents of evaluation specified in pl 3 promulgated together with this Circular and comply with provisions at Clause 2.2 item 2 Chapter III the first part of model bidding dossier for goods procurement promulgated together with the Circular No. 05/2010/TT-BKH.

3. Content of determining the evaluation price:

a) Bid dossiers satisfying requirements on criteria for evaluation, capability, experiences of contractors and criteria for technical evaluation are further considered to determine the evaluation price.

b) Bid dossiers satisfying requirements are determined the evaluation price in accordance with section 26 Chapter I and section 3 Chapter III the first part of model bidding dossier for goods procurement promulgated together with the Circular No. 05/2010/TT-BKH.

Article 8. Conditions to be considered for proposal for winning bid

To comply with provisions in section 31 Chapter I the first part of model bidding dossier for goods procurement promulgated together with Circular No. 05/2010/TT-BKH and items of drug selected for bid winning must satisfy the following conditions:

1. The selected item of drug must satisfy the current provisions on management of medicine price:

a) Price proposed for bid winning of each item of drug is not higher than price in bidding plan already been approved by competent person and not higher than the wholesale price as declared or re-declared which are still valid and made by establishments of medicine manufacture and business to state management agencies.

If item of drug having bid price of all contractors is higher than price in bid plan already been approved by competent authorities, investor may consider and decide drug selected for bid winning as prescribed at Clause 2 Article 20 of the Joint Circular No. 01/2012/TTLT-BYT-BTC;

b) To abide by other relevant provisions on management of medicine price and medicine bid.

2. Item of drug selected for bid winning has the lowest evaluation price under regulations, specified:

a) Item of drug of contractor having the lowest evaluation price in bidding package for medicines under proprietary name or in each medicine group for bidding package for medicines under generic medicine and bidding package for oriental medicines, medicine from materia medica are considered to propose for bid winning.

b) If the evaluation prices is equal each other, selection of item of drug for consideration to propose for bid winning under the priority order as follows:

- Item of drug having high technical point or item of drug produced domestically with equivalent quality;

- To select item of drug with quality, efficiency and used at medical establishments: Based on the expiry date of medicines, violation of medicine quality, duration of using medicines at medical establishments;

- To select item of drug of contractor having experiences, prestige in medicine supply to medical establishment: Base on experiences in supply of contractor, prestige of contractor on medicine supply in medical establishment such as the assurance of supply, implementation of medicine recall, possessing distribution system in geographical area, organizing GPP medicine store chains.

Article 9. Provisions on contract

To comply with the first part of model bidding dossier for goods procurement promulgated together with Circular No. 05/2010/TT-BKH and in contract, compulsorily, it must clearly stipulate the following contents:

1. Obligations and duties of parties in medicine supply, payment and assurance of supply of sufficient medicines according to the result of bid winning in serve of medical examination and treatment of medical establishments.

2. The compensation due to contractual violations shall comply with Article 16 Chapter VIII the third part of model bidding dossier for goods procurement promulgated together with Circular No. 05/2010/TT-BKH in order to ensure in case where contractors fail to supply sufficient medicines under contract, the medical establishments may use the compensation to proactively have medicine source replacing the contractual part unfinished by contractor.

Chapter III

IMPLEMENTATION PRVISIONS

Article 10. Organization of implementation:

1. When submitting for approving the bidding plan, hospitals, institutions having hospital begs affiliated the Ministry of Health; the provincial/municipal Services of Health shall sum up and send report on violations of contractors during bid, medicine supply in previous period of medical establishments in their localities according to Annex 4 promulgated together with this Circular to the Ministry of Health ( the Drug Administration of Vietnam) so as to sum up and announce, do as basis for units to consider, evaluate and select contractors in the next period.

2. The Drug Administration of Vietnam shall sum up and announce information on its website as basis for units to organize, implement the work of bidding for medicine purchase:

a) List of medicines granted registration number or import permit;

b) List of medicines, medicine manufacture establishments violating medicine quality;

c) List of countries participating in EMA, ICH, and PIC/s;

d) List of medicine manufacture establishments which satisfy WHO-GMP standard and granted certificate by Vietnam Ministry of Health (the Drug Administration of Vietnam);

dd) List of medicine manufacture establishments which have medicines registered for circulation in Vietnam satisfying standards of Good manufacturing Practices PIC/s-GMP, EU-GMP as tested and granted certificate by agencies participating in EMA or ICH, or PIC/s;

e) List of data on the declared medicine price, the selected bid medicine price at medical establishments;

g) List of the infringing contractors during bid and medicine supply to medical establishments;

h) List of drugs produced at establishments producing medicines which are granted certificate or satisfying WHO-GMP standard by Vietnam Ministry of Health (the Drug Administration of Vietnam) and licensed for circulation by competent management agencies of countries participating in ICH;

i) List of medicines produced from raw materials (active ingredients) produced in countries participating in ICH; raw materials (active ingredients) which are granted certificate of satisfying CEP;

k) List of drugs franchised by production establishments satisfying EU-GMP or PIC/s-GMP standard of countries participating in ICH and produced at medicine production establishments subject to grant of certificate of satisfying WHO-GMP standard by Vietnam Ministry of Health (the Drug Administration of Vietnam);

l) List of enterprises organizing the GPP medicine store chains;

m) List of enterprises organizing the medicine distribution center.

Article 11. Effect

1. This Circular takes effect on January 01, 2014.

2. The Circular No. 01/2012/TTLT-BYT dated June 28, 2012, of the Minister of health guiding the elaboration of bidding dossier for medicine purchase by medical establishments shall cease to be effective on the effective date of this Circular.

3. For bidding packages already been approved before the effective day of this Circular, further complying with the Joint Circular No. 01/2012/TTLT dated June 28, 2012, of the Minister of Health guiding the elaboration of bidding dossier for medicine purchase by medical establishments.

4. Chairpersons of provincial/municipal People’s Committees; Directors of provincial/municipal Services of Health; Directors of medical establishments and heads of relevant units shall implement this Circular.

In the course of implementation, any arising problems should be reported to the Ministry of Health (the Drug Administration of Vietnam, Department of Planning and Finance) for consideration and settlement.

ANNEX 3

(Promulgated together with the Circular No. 37 /2013/TT-BYT dated November 11, 2013)

THE CRITERIA TABLE FOR TECHNICAL EVALUATION

Note:

(1), (2): Base on information of medicines and establishments producing medicines with quality violation under decisions on withdrawal issued by the Drug Administration of Vietnam and announced on its website (address: http://www.dav.gov.vn).The seriousness of medicine quality violation is defined at clause 3 Article 13 Chapter IV Circular No. 09/2010/TT-BYT dated 28/4/2010 of the Ministry of Health, guiding management of medicine quality. 

(3) “Shelf life of medicine is duration of usage fixed for a patch of medicines and passing this duration, medicines are not permitted using” (according to Clause 21 Article 2 of the Pharmacy Law). Example: Descriptions of medicine on label: Production date: 11/02/2006; expiry date 11/02/2011, shelf life of medicine is 5 years.

(4): Base on list of medicines produced from raw materials produced at countries participating in ICH, raw materials granted CEP certificate as announced on  website of the Drug Administration of Vietnam (address: http://www.dav.gov.vn). (5): Base on list of medicines which have documents proving bioequivalence with original proprietary as announced on  website of the Drug Administration of Vietnam (address: http://www.dav.gov.vn).

(6) Base on import goods declaration of commodities used for bid participation.

(7) Base on notification of winning bid, contract of medicine purchase and sale, invoice of medicine sale for medical examination and treatment establishments which contractor is participating in bid or other medical examination and treatment establishments which contractor has supplied medicines.

(8) Contractor should state clearly in bid dossier about it can satisfy or cannot satisfy requirement of investor/unit (unit organizing bid) about delivery conditions in the biding dossier (at table of provision progress (Chapter VI) and requirement on goods transport (Article 27 Chapter VIII) in the Model Bidding Dossier of goods purchase promulgated together with the Circular No. 05/2010/TT-BKH.

(9) To evaluate this content, base on contract performance involving medicine provision between contractor and investor/unit (unit organizing bid) in case of contractor selected for winning bid in previous year; base on information of violation during bid, medicine provision of contractors at health establishments announced on website of the Drug Administration of Vietnam (address: http://www.dav.gov.vn).

(10) Base on actual conditions of medicine provision of each local, the provincial Health Departments shall define specifically contractors that have distribution system satisfying the medicine provision in their localities, only apply to bidding packages of health establishments in localities of provinces in list.