Thông tư 11/2012/TT-BYT

CIRCULAR

PROVIDING GUIDANCE ON MAKING INVITATIONS TO BID FOR DRUG SUPPLY IN MEDICAL FACILITIES

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

Pursuant to the Law on Investment No. 61/2005/QH11 dated November 29, 2005 of the National Assembly; the Law on the amendment and supplementation of the laws related to fundamental construction No. 38/2009/QH12 dated June 19, 2009 of the National Assembly;

Pursuant to the Government's Decree No. 79/2006/NĐ-CP dated August 09, 2006, detailing the implementation of the Law on Pharmacy;

Pursuant to the Government's Decree No. 85/2009/NĐ-CP dated October 15, 2009, guiding the implementation of the Law on Investment and the selection of contractors according to the Law on Construction;

Pat the Government's Decree No. 118/2008/NĐ-CP dated November 27, 2008, defining the functions, tasks, powers and organizational structure of the Ministry of Finance; Pursuant to the Government's Decree No. 22/2010/NĐ-CP dated March 09, 2010, amending and supplementing Article 3 of the Government's Decree No. 118/2008/NĐ-CP dated November 27, 2008, defining the functions, tasks, powers and organizational structure of the Ministry of Finance;

Pursuant to the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Ministry of Health and the Ministry of Finance, guiding the bid for drug supply in medical facilities;

Pursuant to the Circular No. 05/2010/TT-BKH dated January 10, 2010 of the Ministry of Planning and Investment, specifying the making of Invitation to bid for goods procurement;

The Ministry of Health provides guidance on making invitations to bid for drug supply in medical facilities as follows:

Chapter I

GENERAL REGULATIONS

Article 1. Scope of regulation

1. This Circular provide guidance on making invitations to bid when holding open bidding and restricted bidding in Vietnam to purchase drugs serving the prevention of diseases, medical examination and treatment from the State budget, health insurance fund, and other lawful revenues in medical facilities (hereinafter referred to as units).

2. For the bids for drug supply belonging to projects funded by ODA, this Circular may applies by the sponsor’s consent, or some regulations on bidding in the International Agreements to which the Socialist Republic of Vietnam is a signatory or international agreements, signed by competent organizations of Vietnam, may be amended.

3. This Circular is not applicable in the following cases:

a) Drugs are ordered by the State and paid by the State budget/

b) Herbal ingredients and oriental medicines.

c) Blood and blood products.

Article 2. Subjects of application

This Circular is applicable to the organizations and individuals responsible for making invitation to bid for drug supply in the units funded by the State budget, health insurance fund, and other lawful revenues to purchase drugs that serve the prevention of diseases, medical examination and treatment.

Article 3. Rules for making invitation to bid for drug supply

The invitation to bid for drug supply is made in accordance with the Circular No. 05/2010/TT-BKH dated February 10, 2010 of the Ministry of Planning and Investment, specifying the making of invitation to bid for goods procurement (hereinafter referred to as the Circular No. 05/2010/TT-BKH) the guidance in this Circular, and other relevant legislative documents.

Chapter II

DETAILS OF SOME CONTENTS OF INVITATION TO BID FOR DRUG SUPPLY

Article 4. Conditions for bidding

Apart from complying with Section 2 Chapter I Part 1 of the Invitation form to bid for goods procurement enclosed with the Circular No. 05/2010/TT-BKH bidders must:

1. Bidders shall participate in bid packages suitable for the division of bidding packages in Article 7 of the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 of the Ministry of Health and the Ministry of Finance, providing guidance on bidding for drug supply in medical facilities (hereinafter referred to as the Joint Circular No. 01/2012/TTLT-BYT-BTC).

2. Bidders shall bid for the groups of drugs suitable for the drug classification when bidding for generic drugs in Clause 1 Article 7 of the Joint Circular No. 01/2012/TTLT-BYT-BTC. The bidders having drugs produced in member states of EMA, ICH, or PIC/S, and the bidders having drugs conformable with PIC/S-GMP or EU-GMP standards, inspected and certified by competent agencies of EMA, ICH, or PIC/S, may bid for the groups of drugs produced in member states of EMA or ICHor PIC/S.

Article 5. Contents of bidding documents

The contents of bidding documents are specified in Section 8 Chapter I Part 1 of the Forms of Bidding document, enclosed with the Circular No. 05/2010/TT-BKH in particular:

1. Documentation and information proving the legitimacy, capability, and experience of the bidder:

a) The Certificate of eligibility to sell medicines:

The Certificate must specify whether the business is drug production or drug trading.

b) The Certificate of Good Practice, depending on the type of business:

- GSP (Good Safety Practice): applicable to drug importers.

- GSP (Good Distribution Practice): applicable to drug wholesalers.

- GACP (Good Agricultural and Collection Practice): applicable to herb planters.

- GMP (Good Manufacturing Practice): applicable to drug manufacturers.

c) The documentation proving the capability and experience of the bidder (the existing contracts and the similar contracts performed by the bidder; the capability and experience of the bidder; the financial capacity of the bidder) must comply with the regulations in the Form No. 8, Form No. 9, Form No. 10, and Form No. 12 in Chapter IV of the Forms of invitation to bid for procurement of goods enclosed with the Circular No. 05/2010/TT-BKH

2. The documentation and information proving the legitimacy and conformity of the bidden drugs:

a) Information about the names of bidden drugs, their registration number, or import license number if the drugs have no registration numbers, issued by the Drug administration of Vietnam, and other relevant information:

The bidder must provide all information in Annex 1 enclosed with this Circular. The information must be consistent with the information about the drugs that were issued with registration numbers or import licenses, which are posted on the website of the Drug administration of Vietnam (www.dav.gov.vn);

b) The written commitment to satisfy the units’ requirements in terms of schedule and supply to serve the assessment according to Section 4 of Annex 2 enclosed with this Circular.

3. Other contents

The bidder must provide the following documents (if available):

- Provide the Notice of successful bid, drug sale invoices, etc. to the medical facility for proving the experience of drug supply for assessment in accordance with Section 2 of Annex 3 enclosed with this Circular.

- Provide the Note of reception of Announcement of pharmacy chain conformable with GPP standards, or Certificate of drug distribution center, for assessment in accordance with Section 9 and Section 10 of Annex 3 enclosed with this Circular.

- Provide the documentation specifying the origins of herbal ingredients applicable to oriental medicines and herbal medicines for assessment, in accordance with Section 11 of Annex 3 enclosed with this Circular (sale invoices from the suppliers that are issued with Licenses for producing or trading herbal medicines, or from by herb planters conformable with WHO’s standards).

- Provide sale invoices of antibiotics material produced at home for producing bidden drugs for assessment, in accordance with Section 13 of Annex 3 enclosed with this Circular.

4. The papers provided by bidders when bidding are photocopies that bear the certifying seal of bidders. Bidders only provide information about their Certificates of GMP in Annex 1 of this Circular. This information must be consistent with the information posted on the website of the Drug administration of Vietnam (www.dav.gov.vn).

Article 6. Conditions for eliminating bidding documents

Bidding documents shall be eliminated in accordance with Clause 2 Section 24 Chapter I and Clause 2 Section 24 Chapter II in Part 1 of Forms of invitation for bid for procurement of goods, enclosed with the Circular No. 05/2010/TT-BKH In addition:

1. A bidding document shall be eliminated if:

a) The bidder does not have the Certificate of eligibility to sell medicines issued by competent agencies (the procuring party shall request the bidder to provide the Certificate of eligibility to sell medicines if it is not included in the bidding document).

b)) The Certificate of eligibility to sell medicines does not cover drug production or drug wholesaling

2. A bidden drug shall be eliminated if:

a) The bidden drug or group of drugs does not comply with Article 7 of the Joint Circular No. 01/2012/TTLT-BYT-BTC and Article 4 Chapter II of this Circular.

b) The bidden drug is banned form circulation in Vietnam.

c) The registration number of the bidden drug is revoked while the registration number is unexpired as prescribed in Article 33 Chapter IV of the Circular No. 22/2009/TT-BYT dated November 24, 2009, on drug registration.

d) All products of the bidden drug is banned from circulation and is recalled as prescribed in Clause 1 Article 13 Chapter IV of the Circular No. 09/2010/TT-BYT dated April 28, 2010 of the Ministry of Health, guiding drug quality control.

e) The price of the drug in the bidding document is not fixed (unless the bidder offers various drugs that share the same names of active ingredients, concentration, proportion, and dosage form from various manufacturers).

f) The documentation and information about the bidden drugs provided by the bidder are not accurate (the information is not consistent with the drug registration, drug price list, and Certificates issued by Services of Health and the Ministry of Health).

Article 7. Assessment standards and determination of assessed price

Comply with Chapter I Part 1 of the Forms of Invitation to bid for procurement of goods, enclosed with the Circular No. 05/2010/TT-BKH and the following regulations:

1. Criteria for assessing the capability and experience of the bidder:

a) The criteria for assessing the capability, and experience of the bidder include the contents in Annex 2 enclosed with this Circular.

b) The assessment shall be “passed” or “failed”, in particular:

- The bidders that “pass” all the requirements prescribed in Annex 2 enclosed with this Circular are considered capable and experienced.

- The assessment in Annex 2 enclosed with this Circular is “passed” when all items are “passed”

2. Criteria for technical assessment:

a) The criteria for technical assessment include the contents in Annex 3 enclosed with this Circular.

b) The assessment shall be graded on the scale from 1 to 100, in particular:

- In each Section in Annex 3 enclosed with this Circular, if 2 items or more are passed, the item receiving highest grade shall be counted.

- The minimum technical grade depends on the nature of each bid package or each article in the bidding plan, which is approved by competent persons, but must not be lower than 70 points.

- The bidding documents that receive the grade equal to or exceeding the minimum technical requirement are considered technically satisfactory.

c) For small bid packages (prescribed in Clause 1 Article 33 of the Government's Decree No. 85/2009/NĐ-CP dated October 15, 2009, guiding the implementation of the Law on Investment and the selection of contractors according to the Law on Construction):

The assessments shall be “passed” or “failed” based on the assessment contents in Annex 3 enclosed with this Circular, and comply with the regulations in Clause 2.2 Section 2 Chapter II Part 1 of the Forms of Invitation to bid for procurement of goods, enclosed with the Circular No. 05/2010/TT-BKH.

3. Determination of assessed prices:

a) The bidding documents that satisfy the criteria for assessing the capability and experience of bidders, and satisfy technical assessment standards shall have the assessed prices determined.

b) The assessed prices of satisfactory bidding documents are determined in accordance with Section 26 Chapter I and Section 3 Chapter III Part I of the Forms of Invitation to bid for procurement of goods, enclosed with the Circular No. 05/2010/TT-BKH.

Article 8. Conditions for successful bid

Apart from complying with Section 31 Chapter I Part 1 of Forms of Invitation to bid for procurement of goods, enclosed with the Circular No. 05/2010/TT-BKH the successful drugs must satisfy the following conditions:

1. The successful drugs must satisfy current regulations on drug price management:

a) The successful prices of drugs must not exceed the prices in the bidding plan approved by competent persons, and not exceeding the effective wholesale prices declared by drug manufacturers and drug traders.

If the bidden prices of drugs of all bidders are higher than that in the bidding plan approved by competent authorities, the investor shall consider and decide the successful drugs in accordance with Clause 2 Article 20 of the Joint Circular No. 01/2012/TTLT-BYT-BTC.

b) Other regulation on drug price management and drug procurement must be complied with.

2. The successful drugs have the lowest assessed prices, in particular:

a) The drugs having the lowest assessed price in the bid package of proprietary drugs, or in the bid package of oriental medicines, herbal medicines, or in each group of drugs of generic medicines, shall be selected for consideration.

b) When assessed prices are equal, the drugs shall be selected in the following order:

- Select the drugs having higher technical grade, or the drugs produced at home with equivalent quality;

- Select efficient and quality drugs to use at medical facilities based on their expiry dates, the violation against drug quality regulations, and the period over which they have been used at medical facilities, etc.;

- Select drugs from experienced and reputable contractors to supply drugs to medical facilities: based on the experience and reputation of contractors, the assurance of drug supply and drug recall, the local distribution system, and the GPP pharmacy chain, etc.

Article 9. Regulations on contracts

Apart from complying with the regulations in Part 3 of the Forms of Invitation to bid for procurement of goods, enclosed with the Circular No. 05/2010/TT-BKH a contract must specify the following information:

1. Obligations and responsibilities of all parties for drug supply and payment in accordance with the bid result in order to serve the medical examination and treatment of the medical facility.

2. The compensation for contract violation is specified in Article 16 Chapter VIII Part 3 of the Forms of Invitation to bid for procurement of goods, enclosed with the Circular No. 05/2010/TT-BKH specifying that the medical facility may use the compensation to find alternative suppliers to cover the omitted part of the contract if the contractor fails to provide adequately supply of drugs.

Chapter III

REGULATIONS ON THE IMPLEMENTATION

Article 10. Implementation organization

1. When approving bidding plans, the hospitals and medical facilities affiliated to the Ministry of Health; Services of Health of central-affiliated cities and provinces shall report the violations committed by contractors during biddings and drug supply for local medical facilities in the previous periods (according to Annex 4 enclosed with this Circular) to the Ministry of Health (the Drug Administration of Vietnam) for summarization and announcement as the basis for units to assess and select contractors in the next period.

2. The Drug Administration of Vietnam shall summarize and post the following information on its website for units to organize bidding for drug supply:

a) The list of drugs having registration numbers or import licenses;

b) The list of drugs and drug manufacturers that violate the regulations on drug quality;

a) The List of member states of EMA, ICH, and PIC/s;

d) The list of drug manufacturers conformable with WHO-GMP, inspected and licensed by the Drug Administration of Vietnam (the Ministry of Health);

e) The list of drugs registered and circulated in Vietnam, that are conformable with PIC/S-GMP and EU-GMP, inspected and issued with certificates by agencies participating in EMA, ICH, or PIC/S.

f) The list of declared drug prices and successful prices at medical facilities.

a) The list of violating contractors during the bidding and drug supply for medical facilities.

3. The Presidents of People’s Committees of central-affiliated cities and provinces; Director of Services of Health central-affiliated cities and provinces; Directors of medical facilities and heads of relevant units are responsible for the implementation of this Circular.

Article 11. Effects

1. This Circular takes effect on September 01^st 2012.

2. The invitations for bid approved before this Circular takes effect shall comply with the Law on Investment; the Law on the amendment and supplementation of fundamental construction laws; the Government's Decree No. 85/2009/NĐ-CP dated October 15, 2009;  the Circular No. 05/2010/TT-BKH dated February 10, 2010 of the Ministry of Planning and Investment, and relevant legislative documents.

Units are recommended to send feedbacks on the difficulties arising during the course of implementation to the Ministry of Health (the Drug Administration of Vietnam, the Department of Financial Planning) for consideration and settlement./.

APPENDIX 1

(to the Circular No. 11/2012/TT-BYT dated June 28, 2012)

TABLE OFFERED PRICES

Name of the bidder:

Name of the bid package:

Good manufacture practice of the bidder:

Notes:

1. Unit: use the smallest unit (tablet, tube, vial, pack, bottle, etc.).

2. Declared price and offered price: expressed as VND, inclusive of VAT.

3. Registration number or import license number: specify the registration number of the drug of the import license number (for drugs without registration numbers).

4. Good manufacture practice of the bidder: specify the Certificates of Good Practice (WHO-GMP, PIC/s-GMP, EU-GMP, GSP, GDP) issued to the bidder.

5. Classification: specify whether the drug is produced by the bidder, or imported, or bought to serve the marking:

a. Drugs produced by the bidder are marked “SX"

b. Drugs imported by the bidder are marked “NK".

c. Drugs bought by the bidder from other producers, importers or sellers are marked “KD".

6. The medical facility may add a column to indicate the marking criteria in Appendix 3 to facilitate the bid selection, but the competitiveness, fairness, openness, and economic efficiency must be ensured, and relevant regulations must be complied with.

APPENDIX 2

(to the Circular No. 11/2012/TT-BYT dated June 28, 2012)

CRITERIA FOR ASSESSING CAPABILITY AND EXPERIENCE OF BIDDERS

Notes:

(1) The requirements must be set down based on the amount of drugs and characteristic of the bid package, and must not contradict the Circular No. 05/2010/TT-BKH 

(2) Similar drug supply contracts include drug supply contracts or sale invoices enclosed with the list of drugs supplied to medical facilities, drug producers and drug sellers, in which the categories, characteristics, and amount of drugs are similar to the current bid package.

(3) The bidder shall provide documents proving the fulfillment of tax obligations to the State according to the Form No. 12 enclosed with the Circular No. 05/2010/TT-BKH.

APPENDIX 3

(to the Circular No. 11/2012/TT-BYT dated June 28, 2012)

TECHNICAL CRITERIA

Notes:

(1) In the bidding document, the bidder must indicate whether the procuring party’s delivery requirements in the invitation for bid (supply schedule table – Chapter VI) and the goods transit requirements (Article 27 Chapter VIII) in the form of invitation for bid enclosed with the Circular No. 05/2010/TT-BKH are satisfied or not satisfied.

(2) The bidder’s experience shall be assessed according to the performance of the drug supply contract between the bidder and the procuring party when the bidder won the contract last year, and the information about violations committed during the bidding and drug supply of bidders, which is posted on the website of the Drug Administration of Vietnam (www.dav.gov.vn).

(3) According to the information about drugs and drug producers that violate regulations on drug quality which is posted on the website of the Drug Administration of Vietnam (www.dav.gov.vn).

(4) According to the information about drugs and drug producers that violate regulations on drug quality which is posted on the website of the Drug Administration of Vietnam (www.dav.gov.vn). The seriousness of the violations against regulations on drug quality are specified in Clause 3 Article 13 Chapter IV of the Circular No. 09/2010/TT-BYT dated April 28, 2010 of the Ministry of Health providing guidance on drug quality control.

(5) “Shelf life of a drug is a period of time after which the batch of drugs must not be used (according to Clause 21 Article 2 of the Law on Pharmacy). E.g. a drug label indicates: Date of manufacture: February 11, 2006; date of expiry: February 11, 2011; thus the shelf life of this drug is 5 years.

(6) Services of Health shall determine this according to the drug supply in each province.

APPENDIX 4

(to the Circular No. 11/2012/TT-BYT dated June 28, 2012)

TEMPLATE OF THE REPORT ON DRUG SUPPLY AND BIDDERS’ VIOLATIONS

REPORT ON DRUG SUPPLY AND BIDDERS VIOLATIONS

To: Drug Administration of Vietnam – Ministry of Health.

To implement the Circular No. 11/2012/TT-BYT dated June 28, 2012, [name of unit] hereby reports the violations committed by bidders during drug bidding and drug supply in ………  [year]:

Notes: Specify the violations committed by the bidder during the bidding and the performance of the drug supply contracts according to current regulations on drug bidding and relevant regulations.