MINISTRY OF
HEALTH OF VIETNAM
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No. 03/2024/TT-BYT
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Hanoi, April 16,
2024
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CIRCULAR
PROMULGATING LIST OF
DRUGS MANUFACTURED BY AT LEAST 03 DOMESTIC DRUG COMPANIES IN PROCESSES THAT MEET
EU-GMP PRINCIPLES AND STANDARDS OR EQUIVALENTS AND TECHNICAL SPECIFICATIONS IN
ACCORDANCE WITH REGULATIONS OF THE MINISTRY OF HEALTH CONCERNING QUALITY,
PRICE, AVAILABILITY
Pursuant to the Law on Pharmacy No.
105/2016/QH13 dated April 06, 2016;
Pursuant to the Law on Procurement No.
22/2023/QH15 dated June 23, 2023;
Pursuant to Decree No. 95/2022/ND-CP dated
November 15, 2022 of the Government on functions, tasks, powers and
organizational structure of the Ministry of Health of Vietnam;
At the request of the Director General of
Traditional Medicine Administration (TMA);
The Minister of Health hereby promulgates a list
of drugs manufactured by at least 03 domestic drug companies in processes that
meet EU-GMP principles and standards or equivalents and technical
specifications in accordance with regulations of the Ministry of Health
concerning quality, price, availability.
Article 1. Scope
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Article 2. Principles and criteria of compiling
the list of drugs
Each drug included in the list must satisfy all the
principles and criteria bellows:
1. There are at least 03 (three) Marketing
authorization approval certificates of at least 03 (three) domestic drug
companies meeting EU-GMP principles and standards or equivalents and technical
specifications of Category 1 and/or Category 2 in accordance with regulations
in Circular prescribing bidding for supply of drugs for public health
facilities promulgated by the Minister of Health of Vietnam.
2. The domestic drug price (arithmetic mean of
successful bids) must not exceed the price for imported drugs with equivalent
specifications (in conformity with regulations of the Law on Bidding on
incentives for domestically manufactured drugs).
3. This drug must be adequate for health
facilities.
Article 3. Promulgation and disclosure of the
list of drugs
1. The list of 93 drugs manufactured by at least 03
domestic drug companies in processes that meet EU-GMP principles and standards
or equivalents and technical specifications in accordance with regulations of
the Ministry of Health concerning quality, price, availability is enclosed
herewith.
2. The list of 93 drugs is disclosed in the
Appendix enclosed herewith on the Web portal of the Ministry of Health and the
website of the Traditional Medicine Administration.
Article 4. Update of the list of drugs
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Article 5. Effect
1. This Circular comes into force from the day on
which it is signed.
2. The Circular No. 03/2019/TT-BYT dated March 28,
2019 of the Minister of Health promulgating list of domestically manufactured
drugs meeting treatment requirements, drug prices and availability and Article
1 of Circular No. 15/2022/TT-BYT dated December 09, 2022 of the Minister of
Health amending certain Articles and Appendices of Circular No. 03/2019/TT-BYT
and Circular No. 15/2020/TT-BYT shall be invalid from the effective date of
this Circular.
Article 6. Transitional provisions
If the contractor selection plan is approved and
the request for proposals/bidding documents of a bidding package is issued
before the effective date of this Circular, the regulations that are applicable
before the effective date of this Circular may be applied, unless the health
facility or procuring unit voluntarily applies the regulations of this Circular
from the effective date thereof.
Article 7. Implementation responsibilities
1. The Chief of the Ministry Office, the Director
General of Traditional Medicine Administration, the Director of Department of
Planning and Finance, Heads of relevant units are responsible for
implementation of this Circular.
2. Agencies, organizations and individuals should
report difficulties that arise during the implementation of this Circular to
the Ministry of Health (via the Traditional Medicine Administration) for
consideration and settlement./.
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PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
APPENDIX
LIST OF 93 DRUGS
MANUFACTURED BY AT LEAST 03 DOMESTIC DRUG COMPANIES IN PROCESSES THAT MEET
EU-GMP PRINCIPLES AND STANDARDS OR EQUIVALENTS AND TECHNICAL SPECIFICATIONS IN ACCORDANCE
WITH REGULATIONS OF THE MINISTRY OF HEALTH CONCERNING QUALITY, PRICE,
AVAILABILITY
(enclosed with Circular No. 03/2024/TT-BYT dated April 16, 2024 of the
Minister of Health)
No
(1)
Name of active
ingredient
(2)
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Dosage form
(4)
Unit (5)
Category of
technical specifications
(6)
1
Acyclovir
400mg
Tablets/capsules
Tablets/capsules
2
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Acyclovir
800mg
Tablets/capsules
Tablets/capsules
2
3
Albendazole
400mg
Tablets/capsules
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2
4
Allopurinol
300mg
Tablets/capsules
Tablets/capsules
2
5
Amisulpride
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Tablets/capsules
Tablets/capsules
2
6
Amisulpride
200mg
Tablets/capsules
Tablets/capsules
2
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Atenolol
50mg
Tablets/capsules
Tablets/capsules
2
8
Atorvastatin
10mg
Tablets/capsules
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2
9
Atorvastatin
20mg
Tablets/capsules
Tablets/capsules
2
10
Bambuterol hydrochloride
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Tablets/capsules
Tablets/capsules
2
11
Betahistine dihydrochloride
16mg
Tablets/capsules
Tablets/capsules
2
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Bisoprolol fumarate
5mg
Tablets/capsules
Tablets/capsules
2
13
Bisoprolol fumarate
2,5mg
Tablets/capsules
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2
14
Bisoprolol fumarate
10mg
Tablets/capsules
Tablets/capsules
2
15
Carvedilol
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Tablets/capsules
Tablets/capsules
2
16
Cefazolin
1g
Injectables
Vials
2
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Cefepime
1g
Injectables
Vials
2
18
Cefepime
2g
Injectables
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2
19
Cefoperazone
1g
Injectables
Vials
2
20
Cefoperazone
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Injectables
Vials
2
21
Cefoperazone; Sulbactam
500mg; 500mg
Injectables
Vials
2
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Cefoperazone; Sulbactam
1g; 500mg
Injectables
Vials
2
23
Cefoperazone; Sulbactam
1g; 1g
Injectables
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2
24
Cefotaxime
1g
Injectables
Vials
2
25
Cefotaxime
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Injectables
Vials
2
26
Cefotiam
1g
Injectables
Vials
2
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Ceftazidime
1g
Injectables
Vials
2
28
Ceftazidime
2g
Injectables
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2
29
Ceftazidime
500mg
Injectables
Vials
2
30
Ceftizoxime
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Injectables
Vials
2
31
Ceftriaxone
1g
Injectables
Vials
2
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Cefuroxime
750mg
Injectables
Vials
2
33
Cefuroxime
1,5g
Injectables
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2
34
Cetirizin dihydrochloride
10mg
Tablets/capsules
Tablets/capsules
2
35
Ciprofloxacin
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Tablets/capsules
Tablets/capsules
2
36
Clopidogrel
75mg
Tablets/capsules
Tablets/capsules
2
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Colchicine
1mg
Tablets/capsules
Tablets/capsules
2
38
Diosmin; Hesperidin
450mg; 50mg
Tablets/capsules
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2
39
Domperidone
10mg
Tablets/capsules
Tablets/capsules
2
40
Eperisone hydrochloride
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Tablets/capsules
Tablets/capsules
2
41
Esomeprazole
40mg
Enteric-coated
tablets/capsules
Tablets/capsules
2
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Esomeprazole
20mg
Enteric-coated tablets/capsules
Tablets/capsules
2
43
Etoricoxib
90mg
Tablets/capsules
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2
44
Etoricoxib
120mg
Tablets/capsules
Tablets/capsules
2
45
Ezetimibe
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Tablets/capsules
Tablets/capsules
2
46
Fexofenadine hydrochloride
120mg
Tablets/capsules
Tablets/capsules
2
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Fexofenadine hydrochloride
60mg
Tablets/capsules
Tablets/capsules
2
48
Fluconazole
150mg
Capsules
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2
49
Gabapentin
300mg
Tablets/capsules
Tablets/capsules
2
50
Galantamine
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Tablets/capsules
Tablets/capsules
2
51
Ibuprofen
400mg
Tablets/capsules
Tablets/capsules
2
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Ibuprofen; Paracetamol
200mg; 325mg
Tablets/capsules
Tablets/capsules
2
53
Irbesartan
150mg
Tablets/capsules
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2
54
Irbesartan
300mg
Tablets/capsules
Tablets/capsules
2
55
Lamivudine
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Tablets/capsules
Tablets/capsules
2
56
Lamotrigine
50mg
Tablets/capsules
Tablets/capsules
2
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Lansoprazole
30mg
Capsules
Tablets/capsules
2
58
Levetiracetam
500mg
Tablets/capsules
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2
59
Levocetirizine dihydrochloride
5mg
Tablets/capsules
Tablets/capsules
2
60
Levofloxacin
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Tablets/capsules
Tablets/capsules
2
61
Levofloxacin
250mg
Tablets/capsules
Tablets/capsules
2
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Linezolid
600mg
Tablets/capsules
Tablets/capsules
2
63
Magnesi lactate dihydrate; Vitamin B6
470mg; 5mg
Tablets/capsules
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2
64
Meloxicam
7,5mg
Tablets/capsules
Tablets/capsules
2
65
Metformin hydrochloride
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Tablets/capsules
Tablets/capsules
2
66
Mirtazapin
30mg
Tablets/capsules
Tablets/capsules
2
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Montelukast
10mg
Tablets/capsules
Tablets/capsules
2
68
Montelukast
5mg
Tablets/capsules
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2
69
Nabumeton
500mg
Tablets/capsules
Tablets/capsules
2
70
Nebivolol
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Tablets/capsules
Tablets/capsules
2
71
Olanzapin
5mg
Tablets/capsules
Tablets/capsules
2
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Olanzapin
10mg
Tablets/capsules
Tablets/capsules
2
73
Paracetamol
500mg
Tablets/capsules
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2
74
Paracetamol; Tramadol hydrocloride
325mg; 37,5mg
Tablets/capsules
Tablets/capsules
2
75
Pcrindopril tert-butylamine
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Tablets/capsules
Tablets/capsules
2
76
Piracetam
800mg
Tablets/capsules
Tablets/capsules
2
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Quetiapine
200mg
Tablets/capsules
Tablets/capsules
2
78
Quetiapine
100mg
Tablets/capsules
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2
79
Rabeprazole natri
20mg
Enteric-coated
tablets/capsules
Tablets/capsules
2
80
Rivaroxaban
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Tablets/capsules
Tablets/capsules
2
81
Rosuvastatin
10mg
Tablets/capsules
Tablets/capsules
2
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Rosuvastatin
20mg
Tablets/capsules
Tablets/capsules
2
83
Rosuvastatin
5mg
Tablets/capsules
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2
84
Spiramycin
3.000.000 IU
Tablets/capsules
Tablets/capsules
2
85
Sulpiride
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Tablets/capsules
Tablets/capsules
2
86
Telmisartan
80mg
Tablets/capsules
Tablets/capsules
2
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Telmisartan
40mg
Tablets/capsules
Tablets/capsules
2
88
Tenofovir disoproxil fumarate
300mg
Tablets/capsules
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2
89
Trimetazidine hydrochloride
20mg
Tablets/capsules
Tablets/capsules
2
90
Trimetazidine hydrochloride
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Controlled-release
tablets/capsules
Tablets/capsules
2
91
Valsartan
80mg
Tablets/capsules
Tablets/capsules
2
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Venlafaxin
75mg
Tablets/capsules
Tablets/capsules
2
93
Vitamin B1; Vitamin B6; Vitamin B12
100mg; 200mg;
200mcg
Tablets/capsules
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2
Notes:
1. Regarding names of active ingredients of
drugs:
- If the name of a drug is different from the
name of the active ingredient (chemical name) in Column (2) and is written in
specialized pharmaceutical documents (such as Pharmacopoeia, National
Pharmacopoeia and other documents), the drug still belongs to the list (E.g.
Paracetamol or Acetaminophen; Acyclovir or Aciclovir; Cefuroxime or Cefuroxim;
Sodium or Natri; Hydrochloride or Hydroclorid, etc.).
- If the salt base of an active ingredient in
Column (2) is not specified, different salts of this active ingredient, after
being converted into bases with the same concentrations and content in Column
(3) (with the same indications and dosage) still belong to the list.
2. The bidding for a drug whose dosage form is
different from that written in Column (4) shall comply with regulations on drug
bidding.
3. “Regarding dosage forms written in Column
(4):
- Dosage forms "Tablets/capsules",
"Injectables" written in Column 4 are conventional dosage forms
(Pills: Tablets, Capsules; Injectables: Solution for injection, Suspension for
injection, Emulsion for injection).
- Procuring units and health facilities are
permitted to develop their own contractor selection plans in which bidding
documents and request for proposals permit bidders to offer imported drugs with
special dosage forms or drugs with bioavailability that is different from
conventional dosage forms (E.g. Enteric-coated tablets/capsules,
Controlled-release tablets/capsules, Fast disintegrating tablets/capsules,
Effervescent tablets, Sublingual tablets; Lyophilized injectables,
Liposomal/nano/lipid complex injectables, Intraocular injectables, Long-acting
injectables, Metered-dose injection applicators, etc.)”.
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