THE MINISTRY OF HEALTH
Circular No.31/2014/TT-BYT dated September 26, 2014 of the Ministry of Health prescribing the technical evaluation criteria for the medicine’s bid documents
Pursuant to the Law on Investment dated November 26, 2013;
Pursuant to the Government s Decree No. 63/2014/ND-CP dated June 26, 2014 on guidelines for some Articles on contractor selection of the Law on Investment;
Pursuant to the 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;
At the request of Drug Administration of Vietnam and the Director of Planning-Finance Department;
The Minister of Health promulgates a Circular on technical evaluation criteria of invitation to bid for medicine supply.
Article 1.Technical evaluation criteria for the medicine’s bid documents
1. The technical evaluation criteria for the medicine’s bid documents are specified in attached Appendix 1.
2. The score shall be given on a scale of 1 to 100, in particular:
a) Medicine quality: 70/100.
b) Packaging, preservation, delivery: 30/100.
c) A technical proposal is considered technically satisfactory when all of the requirements below are satisfied:
- The scores of each criterion for medicine quality and packaging, preservation, delivery are not lower than 60% of the maximum scores.
- The total score of all technical criteria is not lower than 80%.
3. The bid-envelopes that satisfy criteria for bidder’s competence and experience as well as technical requirements shall undergo general evaluation as prescribed in Article 24 of the Government sDecree No. 63/2014/ND-CP dated June 26, 2014 detailing a number of articles of the Bidding Law regarding contractor selection
Article 2. Implementation effect
This Circular takes effect on the signing date.
To annul the Clause 2 Article 7 of the Circular No. 37/2013/TT-BYT dated November 11, 2013, guiding the elaboration of bidding dossier for medicine purchase in medical establishments are on this Circular’s effective date.
Article 3. Transitional provisions
1. The bid documents before August 15, 2014 shall follow the regulations on bidder evaluation of Circular No. 37/2013/TT-BYT dated November 11, 2013.
2. The bid documents after August 15, 2014 and are not conformable with this Circular to be adjusted to this Circular.
Article 4. Implementation responsibilities
Director of Drug Administration of Vietnam, Director of Planning and Finance Department, Chief of the Ministry Office, Directors of Departments affiliated to the Ministry of Health, Directors of units affiliated to the Ministry of Health, Directors of provincial Services of Health, heads of health authorities of other Ministries are responsible for the implementation of this Circular.
Difficulties arising on the course of implementation of this Circular should be reported to the Ministry of Health (the Department of Planning and Finance) for consideration./.
For the Minister of Health
The Deputy Minister
Pham Le Luan
APPENDIX 1
(Issued with Circular No. 31/2014/TT-BYT dated September 26, 2014 of the Minister of Health)
TECHNICAL EVALUATION CRITERIA
No. | Contents | Score |
I | Medicine quality criteria: 70 points. |
1 | The offered medicines are produced by the bidder: 25 points |
| 1.1. Conformity with PIC/s-GMP, EU-GMP: | |
a) From a member state of ICH | 25 |
b) Not from a member country of ICH, granted Certificate of WHO-GMP by the Ministry of Health of Vietnam (Drug Administration of Vietnam) | 23 |
c) Not from a member country of ICH, not yet granted Certificate of WHO-GMP by the Ministry of Health of Vietnam (Drug Administration of Vietnam) | 21 |
1.2. Conformity with WHO-GMP: | |
a) Granted Certificate of WHO-GMP by the Ministry of Health of Vietnam (Drug Administration of Vietnam) and granted License for free sale by competent authority of a member country of ICH | 24 |
b) Granted Certificate of WHO-GMP by the Ministry of Health of Vietnam (Drug Administration of Vietnam) and granted a manufacturing franchise free by a facility from a member state of ICH that conforms with PIC/s-GMP, EU-GMP. | 22 |
c) Granted Certificate of WHO-GMP by the Ministry of Health of Vietnam (Drug Administration of Vietnam) | 21 |
d) Not granted Certificate of WHO-GMP by the Ministry of Health of Vietnam (Drug Administration of Vietnam) | 20 |
1.3. Oriental medicines and herbal medicines produced by the bidder: | |
a) Granted Certificate of WHO-GMP by the Ministry of Health of Vietnam (Drug Administration of Vietnam) | 25 |
b) Not yet inspected and granted Certificate of WHO-GMP by the Ministry of Health of Vietnam (Drug Administration of Vietnam) | 20 |
2 | Violations pertaining to quality of offered medicines (1): 10 points |
| 2.1. No violations pertaining to quality found over the past one year. | 10 |
2.1. Violations pertaining to quality found over the past one year. a) Level 3 violations. b) Level 2 violations. | 6 0 |
3 | Violations pertaining to quality committed by the producer of offered medicines (2): 10 points |
| 2.1. No violating products over the past one year. | 10 |
| 3.2. There is 01 violating product over the past one year. | 9 |
| 3.3. There are 02 violating products over the past one year. | 6 |
| 3.3. There are ≥ 03 violating products over the past one year. | 0 |
4 | Shelf life of offered medicines (3): 10 points |
| 4.1. ≥ 3 years | 10 |
4.2. From 2 years to < 3 years | 9 |
4.3. < 2 years | 8 |
5 | Criteria for evaluating raw materials (active ingredients) of offered medicines: 5 points |
| 5.1. Raw materials (active ingredients) are manufactured in member states of ICH. | 5 |
| 5.2. Raw materials (active ingredients) are manufactured in countries other than member states of ICH and are granted CEPs. | 4 |
| 5.3. Other cases. | 3 |
6 | Criteria for bioequivalence evaluation: 5 points |
| 6.1. There are documents issued by the Ministry of Health proving bioequivalence of the offered medicines that are required to undergo bioequivalence testing | 5 |
| 6.2. The offered medicines are exempt from reporting bioequivalence data. | 5 |
| 6.3. There are documents proving bioequivalence issued by the Ministry of Health. | 3 |
7* | Medicines are derived from antibiotic materials manufactured domestically ( not applied to oriental medicines and herbal medicines): 5 points |
| 7.1. Offered medicines are derived from antibiotic materials manufactured domestically | 5 |
| 7.2. Offered medicines are derived from materials other than antibiotic materials manufactured domestically. | 4 |
8* | Offered medicines are oriental medicines or herbal medicines (only applied to oriental medicines and herbal medicines): 5 points |
| 8.1. Offered medicines are derived from herbal ingredients that are granted GACP certificates. | 5 |
| 8.2. Offered medicines are derived from herbal ingredients of clear origins. | 3 |
| 8.3. Offered medicines are derived from herbal ingredients whose origins are not proven. | 0 |
II | Criteria for packaging, preservation, delivery: 30 points |
9 | Offered medicines are supplied by the bidder: 5 points |
| 9.1. The bidder is the producer of offered medicines. | 5 |
9.2. The bidder is also the importer of offered medicines. (6) | 4 |
9.3. The bidder is not the producer of importer of offered medicines. | 3 |
10 | Medicines are supplied by a bidder experienced in medicine supply (7): 5 points |
| 10.1. The bidder has supplied medicines for the medical facility for 3 years or more. | 5 |
10.2. The bidder has supplied medicines for the medical facility for less than 3 years. | 4 |
10.3. The bidder has not supplied medicines for the medical facility. | 3 |
11 | The bidder’s ability to satisfy delivery terms (8): 3 points |
| 11.1. Delivery terms in the invitation for bids are satisfied | 3 |
| 11.2. Delivery terms in the invitation for bids are not satisfied | 0 |
12 | Medicines are supplied by a reputable bidder (9): 8 points |
| 12.1. The bidder has not committed any breaches of contracts to supply medicines for medical facilities. a) The bidder won a medicine supply contract with the investor and met the schedule. b) The bidder won a medicine supply contract with the investor but failed to meet the schedule. c) The bidder has not won any contract with the investor. |
8
7
6
|
| 12.2. There are violations pertaining to bidding for medicine supply for medical facilities. | 5 |
13 | The bidder has a GPP pharmacy chain: 3 points |
| 13.1. The bidder has a GPP pharmacy chain. | 3 |
| 13.2. The bidder does not have a GPP pharmacy chain. | 2 |
14 | The bidder has a medicine distribution center: 3 points |
| 14.1. The bidder has a medicine distribution center. | 3 |
14.2. The bidder does not have a medicine distribution center. | 2 |
15 | The bidder has widespread system for distributing medicines in highlands and disadvantaged areas (10): 3 points |
| 15.1. The bidder has a widespread system for distributing medicines in the whole province (only applied to the following provinces: Ha Giang, Cao Bang, Bac Kan, Lao Cai, Yen Bai, Bac Giang, Phu Tho, Dien Bien, Lai Chau, Son La, Thanh Hoa, Nghe An, Quang Binh, Quang Tri, Quang Nam, Quang Ngai, Binh Dinh, Ninh Thuan, Kon Tum, Lam Dong, Quang Ninh, Ha Tinh, Gia Lai, Phu Yen, Hoa Binh, Tuyen Quang) | 3 |
| 15.2. Other cases. | 2 |
Notes:
(1), (2): according to information about medicines and medicine producers that commit violations pertaining to quality on the website of Drug Administration of Vietnam (http://www.dav.gov.vn). The seriousness of violations are specified in Clause 3 Article 13 Chapter IV ofCircular No. 09/2010/TT-BYT dated April 28, 2010 of the Ministry of Health on guiding the management of medicine quality
(3) “Shelf life of a batch of medicines is a fixed period of time after which the batch of medicines must not be used" (Clause 21 Article 2 of the Law on Pharmacy). Example: manufacture date: February 11, 2005; expiry date: February 11, 2011; the shelf life is 5 years.
(4) According to the list of medicines derived from raw materials produced in member states of ICH and granted CEPs on the website of Drug Administration of Vietnam (http://www.dav.gov.vn).
(5) According to the list of medicines having documents proving bioequivalence on the website of Drug Administration of Vietnam (http://www.dav.gov.vn) and inCircular No. 08/2010/TT-BYT dated April 26, 2010, of the Ministry of Health guiding report of bioavailability/bioequivalence study data when registering drugs.
(6) According to the import declaration.
(7) According to the notification of successful bidder, medicine supply contracts, and invoices for medicine sold to medical facilities.
(8) The bidder’s ability to satisfy the investor’s delivery terms must be specified (using the form provided in Chapter VI and delivery requirements in Article 27 of Chap VIII) according to the model invitation for bids enclosed with Circular No. 05/2010/TT-BKH.
(9) According to the medicine supply contract between the bidder and the investor in case the bidder wins the contract; according to information about violations during bidding process or medicine supply process on the website of Drug Administration of Vietnam (http://www.dav.gov.vn).
(10) According to the supply of medicine in the province, Services of Health shall determine the bidders whose distribution systems are capable of medicine supply in the province (only applied to the provinces stated above).
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