Circular No. 11/2016/TT-BYT dated May 11, 2016 of the Ministry of Health on bidding for drugs supply for public health facilities

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Circular No. 11/2016/TT-BYT dated May 11, 2016 of the Ministry of Health on bidding for drugs supply for public health facilities
Issuing body: Ministry of HealthEffective date:
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Official number:11/2016/TT-BYTSigner:Pham Le Tuan
Type:CircularExpiry date:
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Issuing date:11/05/2016Effect status:
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Fields:Bidding - Competition , Medical - Health

SUMMARY

Apply competitive offering with drug bidding packages whose price does not exceed VND 5 billion

According to the Circular No. 11/2016/TT-BYT dated May 11, 2016 of the Ministry of Health on bidding for drugs supply for public health facilities, competitive offering shall be applied with drug bidding packages that price does not exceed VND 05 billion, has contractor selection plan approved by the competent person; the drug to be procured is on the List of essential medicines promulgated by the Ministry of Health or a commonly available drug whose technical characteristics and quality have been standardized and equivalent. If the procurement is funded by state budget, it is required to have an approved cost estimate.

For the direct procurement, it shall be applied with drug bidding packages that meet such conditions as bellow: The contractor has won the contract through competitive bidding or selective bidding and has signed a contract earlier; The current procurement includes similar drugs and the scale is smaller than 130% of the earlier contract; Unit prices of drugs of the direct procurement do not exceed those of corresponding drugs in the earlier contract and suitable for the successful bids announced at the time of contract negotiation; The period of time from the conclusion date of the earlier contract to the day on which the direct procurement result is approved must not exceed 12 months.

Single-stage two-envelop procedures shall be applied to drug procurements through open tender or selective bidding whose value exceeds VND 10 billion and drug procurements whose value does not exceed 10 billion VND through open tender or selective bidding but both quality and prices have to be taken into account.

This Circular takes effect on July 01, 2016.
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THE MINISTRY OF HEALTH

Circular No. 11/2016/TT-BYT dated May 11, 2016 of the Ministry of Health on bidding for drugs supply for public health facilities
Pursuant to the Law on Bidding No. 43/2013/QH13 dated November 26, 2013;
Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;
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 Bidding;
Pursuant to the Government's Decree No. 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;
Pursuant to the Prime Minister’s Decision No. 08/2016/QD-TTg dated February 26, 2016 on concentrated procurement of state-owned property;
In consideration of opinions of the Ministry of Finance in Official Dispatch No. 441/BTC-HCSN dated January 12, 2016 and the Ministry of Planning and Investment in Official Dispatch No. 10485/BKHDT-QLDT dated November 26, 2015;
At the request of Director of Planning – Finance Department,
The Minister of Health promulgates a Circular on bidding for supply of drugs for public health facilities.
Article 1. Scope and subject of application
1. This Circular provides for bidding for supply of drugs funded by state capital, health insurance fund, proceeds from medical examination and treatment services, and other lawful sources of income of public health facilities.
2. This Circular does not apply to:
a) Drugs ordered by the State: Comply with the Government's Decree No. 130/2013/ND-CP dated October 16, 2013 on the production and provision of public-utility products and services;
b) Medical oxygen, nitrite oxide, in vitro diagnostic reagents: Comply with regulations of law on bidding for procurement of goods serving regular operation of state agencies, the People’s armed force units, public service agencies, political organizations, socio-political organizations, socio-political-professional organizations, social organizations, socio-professional organizations;
c) Whole blood, qualified blood preparations: Comply with Circular No. 33/2014/TT-BYT dated October 27, 2014 of the Minister of Health on maximum prices and cost of pricing a unit of whole blood or blood qualified preparation.
3. This Circular applies to agencies, organizations and individuals participating or involved in bidding for supply of drugs prescribed in Clause 1 of this Article.
4. Private health facilities participating in provision of medical examination and treatment services covered by health insurance may apply this Circular.
For the purpose of this Circular, the terms below are construed as follows:
1. Original brand name drug means the first drug granted the certificate of free sale based on sufficient data about its quality, safety and efficacy.
2. Generic drug means a drug having the same active ingredient, concentration, dosage form as those of the original brand name drug and is used as a substitute for the original brand name drug.
3. Bioavailability means an indicator of degree and rate at which an active ingredient or substance in a drug is absorbed into the body for it to be available at the site of physiological activity inside the body.
4. Bioequivalence means the equivalence of bioavailability between two drugs under the same conditions.
5. Herbal ingredient means a medicinal ingredient derived from plants, animals, minerals and is qualified for medicinal use.
6. Traditional ingredient means an herbal ingredient that is processed according to traditional drug principles and methods and is used for production of traditional drugs, prevention or treatment of diseases.
7. Herbal drug means a drug whose ingredients are derived from herbal ingredients and its effects are supported by scientific evidence, except for traditional drugs.
8. Traditional drug (including traditional ingredients) means a drug that composed herbal ingredients that are processed, prepared, or combined according to traditional drug principles or methods; it may have a traditional or modern dosage form.
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