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MINISTRY OF HEALTH - MINISTRY OF FINANCE
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.:
36/2013/TTLT-BYT-BTC
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Hanoi,
November 11, 2013
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JOINT CIRCULAR
AMENDING AND
SUPPLEMENTING A NUMBER OF ARTICLES OF 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 BIDDING FOR MEDICINE PURCHASE BY 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 Government’s Decree No.
118/2008/ND-CP dated November 27, 2008, defining the functions, tasks, powers
and organizational structure of the Ministry of Finance,
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Article 1. To supplement point d into Clause 2
Article 2 as follows:
“d) Medical oxygen.”
Article 2. To supplement Clauses 6 and 7 into
Article 3 as follows:
“6. Establishments producing medicines
satisfying EU-GMP or PIC/s-GMP standard mean medicine producers granted
certificate of satisfying EU-GMP or PIC/s-GMP standard or equivalent by
competent management agencies of countries participating in EMA or ICH or PIC/s
and published on website of the Drug Administration of Vietnam by the Ministry
of Health (Drug Administration of Vietnam).
7. Countries participating
in ICH include EU countries, Japan, American and countries which are
observers of ICH and associated members of ICH’s members, as announced by the
Ministry of Health (Drug Administration of Vietnam) based on the list updated
by ICH.”
Article 3. To amend and supplement Clauses 1 and
3 of Article 7 as follows:
“1. Bidding package for medicines under generic
name:
Bidding package for medicines under generic name
may have one or many medicines under generic name. Each generic under generic
name is divided into group based on technical criteria and technological
standards licensed as follows:
a) Group 1:
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- Drugs produced at establishments producing
medicines which satisfy WHO-GMP standard and granted certificate by Vietnam
Ministry of Health (the Drug Administration of Vietnam) and licensed for
circulation by competent management agencies of countries participating in ICH.
b) Group 2:
- Drugs produced at production establishments
satisfying EU-GMP or PIC/s-GMP standard but not being countries participating
in ICH;
- 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).
c) Group 3: Drugs produced at establishments
producing medicines which satisfy WHO-GMP standard and granted certificate by
Vietnam Ministry of Health (the Drug Administration of Vietnam).
d) Group 4: Drugs having bioequivalence proof
announced by the Ministry of Health.
dd) Group 5: Drugs failing to satisfy criteria of
classification specified at points a, b, c and d Clause 1 this Article.”
“3. Bidding packages of oriental medicines,
medicines from materia medica.
Bidding packages of oriental medicines, medicines
from materia medica are classified into groups based on technical criteria and
technological standards licensed as follows:
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b) Group 2: oriental drugs, drugs from materia
medica produced at establishments which have not yet been granted certificate
of satisfying WHO-GMP standard by Vietnam Ministry of Health (the Drug
Administration of Vietnam).
Article 4. To amend points b and c Clause 1 of
Article 8 as follows:
“b) For a bidding package under proprietary
medicine name, content of bidding package includes: Medicine name, name of active
ingredients, concentration or content, dosage forms, calculation unit,
quantity, tentative price as planned and inclusive of VAT, and must enclose
with phrase “or equivalent treatment” If an active ingredient has various
proprietary names already been announced by the Ministry of Health at list of
original proprietary medicines or rare medicines, the proprietary name enclosed
with phrase “or equivalent treatment” need be written in item of medicine name.
Example: Proprietary name A or Proprietary name B or equivalent treatment.”
“c) For bidding packages of oriental medicines,
medicines from materia medica, content of a bidding package includes medicine
name, dosage form, calculation name, quantity, and tentative price as planned
and inclusive of VAT. Medicine names in bidding packages of oriental
medicines, medicines from materia medica shall be written as follows:
- Only write name of components of medicine, not
writing commercial name;
- If medicine has a same components, dosage form:
Only write the concentration, content of medicine components when having
differences of concentration, content that result the differences of dose,
treatment indication of medicines. The Councils of medicines and treatment of
medical examination and treatment establishments shall decide on the
description of concentration, content of medicines in bidding packages for
oriental medicines, medicines from materia medica in order to ensure the
principles of competition and fairness between bidding packages for oriental
medicines, medicines from materia medica.”
Article 5. To amend and supplement Clauses 2 and
3 of Article 16 as follows:
“2. For bidding packages for medicines under
generic name, and bidding packages for oriental medicines, medicines from
materia medica: Each medicine group only is considered for bid winning of 01
item of drug which meets technical and quality requirements specified in
bidding dossier and has lowest price among such medicine group."
“3. For bidding packages for medicines under
proprietary name: Each drug only is considered for bid winning of 01 item of
drug which meets technical and quality requirements specified in bidding
dossier and has lowest price among bidding packages."
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“d) Medicines named in list of medicines under the
approved bid plan, but in year, their use demand exceeds the plan approved by
competent authorities. Quantity of each item of drug allowed
purchasing in excess of annual plan will not more than 20% of the quantity of
that drug as winning bid. Total value of medicines allowed purchasing in excess
of plan of unit in this case is not more than 02 (two) billion Vietnam
dong/year.”
Article 7. To amend and supplement Clauses 1 and
4 of Article 26 as follows:
“1. The Ministry of Health shall announce, update
list of countries participating in EMA, ICH, PIC/s; list of medicine production
establishments satisfying EU-GMP or PIC/s-GMP standard; list of medicine
producers satisfying WHO-GMP standard and granted certificate by Vietnam’s
Ministry of Health (the Drug Administration of Vietnam); list of original
proprietary medicines, medicines of equivalent treatment in comparison with the
original proprietary medicines; medicines having documents to prove bioequivalence;
list of medicines franchised from medicine production establishments satisfying
EU-GMP or PIC/s-GMP standard of countries participating in ICH and produced at
medicine production establishments granted certificate of satisfying WHO-GMP
standard by Vietnam’s Ministry of Health (the Drug Administration of Vietnam);
list of medicines produced at medicine production establishments
satisfying WHO-GMP standard and granted certificate by Vietnam’s Ministry of
Health (the Drug Administration of Vietnam) and licensed for circulation by
competent management agencies of countries participating in ICH.”
“4. Social insurance agencies shall appoint
officers to participate in Council for appraising the bidding plan, group for
elaboration of bidding dossier, group for bidding verification and group for
appraising result of contractor selection in case of bidding for drug purchase
from fund of medical insurance under decentralization of General Director of
Vietnam Social Insurance.”
Article 8. Effect
1. This Circular takes effect on January 01, 2014.
2. Clauses 1, Clause 3 Article 7; points b and c
Clause 1 Article 8; Clauses 2 and 3 Article 16; point d Clause 1 Article 23;
Clauses 1 and 4 Article 26 of 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 bidding for medicine purchase by medical establishments cease to be
effective on the effective date of this Circular.
3. For bidding packages already been submitted for
approval for bidding plan before the effective day of this Circular, further
complying with 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 bidding
for medicine purchase by medical establishments.
Article 9. Organization of implementation
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FOR THE
MINISTER OF FINANCE
DEPUTY MINISTER
Nguyen Thi Minh
FOR THE
MINISTER OF HEALTH
DEPUTY MINISTER
Nguyen Thi Xuyen