Tiếng Việt| MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
| No.: 06/2017/TT-BYT | Hanoi, May 03, 2017 |
PROMULGATING LIST OF TOXIC DRUGS AND TOXIC MEDICINAL INGREDIENTS
Pursuant to the Pharmaceutical Law dated April 06, 2016;
Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 defining Functions, Tasks, Powers and Organizational Structure of Ministry of Health;
At the request of Director of the Drug Administration of Vietnam;
Minister of Health promulgates the “Circular on promulgation of List of Toxic Drugs and Toxic Medicinal Ingredients”.
This Circular provides for rules for compiling the List of toxic drugs and toxic medicinal ingredients and criteria for selection of toxic drugs and toxic medicinal ingredients for inclusion in the List; the List of toxic drugs and toxic medicinal ingredients as active ingredients and modern drugs; purposes of the List and implementation thereof.
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1. Rules for compiling the List of toxic drugs and toxic medicinal ingredients:
a) Ensure safety for drug users;
b) Ensure people’s timely access to drugs;
c) Conform to the reality of use and supply of drugs in Vietnam;
d) Be harmonized with rules and regulations on classification of toxic drugs and toxic medicinal ingredients announced by the States in the region and the world.
dd) Base on the approved package inserts, the National Pharmacopoeia, the world drug databases, articles published on academic journals and other relevant documents.
2. Criteria for selection of toxic drugs and toxic medicinal ingredients for inclusion in the List of toxic drugs and toxic medicinal ingredients:
Drugs and medicinal ingredients that threaten to cause one or several of the following effects on human body shall be selected for inclusion in the List of toxic drugs and toxic medicinal ingredients:
a) Carcinogenicity;
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c) Reproductive toxicity;
d) Organ toxicity at low doses;
dd) Genotoxicity.
Article 3. List of toxic drugs and toxic medicinal ingredients
The List of toxic drugs and toxic medicinal ingredients is enclosed with this Circular.
Article 4. Purposes of List of toxic drugs and toxic medicinal ingredients
The List of toxic drugs and toxic medicinal ingredients is aimed to serve regulatory authorities in course of implementation of regulations on management of toxic drugs and toxic medicinal ingredients in terms of trading, labeling, prescription, distribution, preparation, storage, use, inspection, violation settlement and other relevant activities.
This Circular takes effect as from July 01, 2017.
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1. With regard to drugs and medicinal ingredients that have registration number of import permit before the date of entry into force of this Circular, holders of certificate of free sales and importers of drugs and medicinal ingredients must classify, update and provide additional information concerning classifications of drugs and medicinal ingredients in accordance with regulations herein on drug labels and package inserts according to the roadmap prescribed in Minister of Health’s Circulars on labeling of drugs and medicinal ingredients before selling such of drugs and medicinal ingredients on the market.
2. Drugs and active ingredients of which applications for sale registration in Vietnam or applications for permit to import drugs without certificate of free sale in Vietnam have been submitted to the Drug Administration of Vietnam before the date of entry into force of this Circular but are not yet processed must be classified in accordance with regulations herein.
Article 7. Implementation responsibility
1. Responsibility of pharmacy establishments and health facilities:
a) Implement regulations on management of toxic drugs and toxic medicinal ingredients on the List laid down in Article 3 herein in accordance with regulations in Minister of Health’s Circulars providing guidelines for implementation of certain Articles of the Pharmaceutical Law with regard to controlled drugs;
b) Propose revision to the List of toxic drugs and toxic medicinal ingredients in conformity with the reality to ensure the timely provision of drugs serving the prevention and treatment of diseases.
2. Responsibility of the Drug Administration of Vietnam:
a) Take charge of and cooperate with regulatory bodies in implementing this Circular;
b) Review the List of toxic drugs and toxic medicinal ingredients and submit reports thereof to the Minister of Health according to proposals and suggestions of units mentioned in Clause 1 of this Article or conclusion of the Advisory Council for issuance of certificate of free sale of drugs and medicinal ingredients.
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PP MINISTER
DEPUTY MINISTER
Truong Quoc Cuong
OF TOXIC DRUGS AND TOXIC MEDICINAL INGREDIENTS
(Enclosed with the Circular No. 06/2017/TT-BYT dated May 03, 2017 by Minister of Health)
No.
Toxic medicinal ingredients/ Drugs containing toxic ingredients
Administration route and dosage form
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Abiraterone
Oral administration: various forms
2
Valproic acid
Oral administration: various forms; Intravenous administration: various forms
3
Anastrozole
Oral administration: various forms
4
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Intravenous administration: various forms
5
Atracurium besylate
Intravenous administration: various forms
6
Atropine sulfate
Intravenous administration: various forms
7
Azacitidine
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8
Bicalutamide
Oral administration: various forms
9
Bleomycin
Intravenous administration: various forms
10
Bortezomib
Intravenous administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Botulinum toxin
Intravenous administration: various forms
12
Bupivacaine
Intravenous administration: various forms
13
Capecitabine
Oral administration: various forms
14
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Oral administration: various forms
15
Carboplatin
Intravenous administration: various forms
16
Carmustine
Intravenous administration: various forms
17
Cetrorelix
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
18
Chlorambucil
Oral administration: various forms
19
Choriogonadotropin alfa
Intravenous administration: various forms
20
Cisplatin
Intravenous administration: various forms
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Colistin
Intravenous administration: various forms
22
Conjugated Oestrogens
Oral administration: various forms
23
Cyclophosphamide
Oral administration: various forms; Intravenous administration: various forms
24
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Oral administration: various forms
25
Cytarabine
Intravenous administration: various forms
26
Dacarbazine
Intravenous administration: various forms
27
Dactinomycin
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28
Daunorubicin
Intravenous administration: various forms
29
Degarelix
Intravenous administration: various forms
30
Desflurane
Volatile liquid
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Dexmedetomidine
Intravenous administration: various forms
32
Docetaxel
Intravenous administration: various forms
33
Doxorubicin
Intravenous administration: various forms
34
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Oral administration: various forms
35
Epirubicin
Intravenous administration: various forms
36
Erlotinib
Oral administration: various forms
37
Estradiol
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
38
Etoposide
Oral administration: various forms; Intravenous administration: various forms
39
Everolimus
Oral administration: various forms
40
Exemestane
Oral administration: various forms
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Fludarabine
Intravenous administration: various forms
42
Fluorouracil (5-FU)
Intravenous administration: various forms
43
Flutamide
Oral administration: various forms
44
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Intravenous administration: various forms
45
Ganciclovir
Intravenous administration: various forms
46
Ganirelix
Intravenous administration: various forms
47
Gefitinib
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48
Gemcitabine
Intravenous administration: various forms
49
Goserelin
Intravenous administration: various forms
50
Halothan
Volatile liquid
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Hydroxyurea
Oral administration: various forms
52
Ifosfamide
Intravenous administration: various forms
53
Imatinib
Oral administration: various forms
54
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Intravenous administration: various forms
55
Isoflurane
Volatile liquid
56
Lenalidomide
Oral administration: various forms
57
Letrozole
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
58
Leuprorelin (also known as Leuprolide)
Intravenous administration: various forms
59
Levobupivacaine
Intravenous administration: various forms
60
Medroxy progesterone acetate
Intravenous administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Menotropin
Intravenous administration: various forms
62
Mepivacaine
Intravenous administration: various forms
63
Mercaptopurine
Oral administration: various forms
64
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Oral administration: various forms; Intravenous administration: various forms
65
Methyltestosterone
Oral administration: various forms
66
Mitomycin C
Intravenous administration: various forms
67
Mitoxantrone
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68
Mycophenolate
Oral administration: various forms
69
Neostigmine methylsulfate
Intravenous administration: various forms
70
Nilotinib
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Octreotide
Intravenous administration: various forms
72
Oxaliplatin
Intravenous administration: various forms
73
Oxcarbazepine
Oral administration: various forms
74
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Intravenous administration: various forms
75
Paclitaxel
Intravenous administration: various forms
76
Pamidronate disodium
Oral administration: various forms; Intravenous administration: various forms
77
Pancuronium bromide
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
78
Pazopanib
Oral administration: various forms
79
Pemetrexed
Intravenous administration: various forms
80
Pipecuronium bromide
Intravenous administration: various forms
...
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Procaine hydrocloride
Intravenous administration: various forms
82
Progesterone
Intravenous administration: various forms
83
Propofol
Intravenous administration: various forms
84
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Intravenous administration: various forms
85
Ribavirin
Oral administration: various forms; Intravenous administration: various forms
86
Rocuronium bromide
Intravenous administration: various forms
87
Ropivacaine
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
88
Sevoflurane
Volatile liquid
89
Sirolimus
Oral administration: various forms
90
Sorafenib
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Sunitinib
Oral administration: various forms
92
Suxamethonium chloride
Intravenous administration: various forms
93
Tacrolimus
Oral administration: various forms; Intravenous administration: various forms
94
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms
95
Tamoxifen
Oral administration: various forms
96
Temozolomide
Oral administration: various forms
97
Testosterone
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
98
Thalidomide
Oral administration: various forms
99
Thiopental
Intravenous administration: various forms
100
Thiotepa
Intravenous administration: various forms
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Thymosin alpha I
Intravenous administration: various forms
102
Topotecan
Oral administration: various forms; Intravenous administration: various forms
103
Triptorelin
Intravenous administration: various forms
104
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms
105
Valganciclovir
Oral administration: various forms
106
Vecuronium bromide
Intravenous administration: various forms
107
Vinblastine
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
108
Vincristine
Intravenous administration: various forms
109
Vinorelbine
Intravenous administration: various forms
110
Zidovudine
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Ziprasidone
Oral administration: various forms
* The List includes salts of substances mentioned in the foregoing table in case they are formed and exist./.