MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No.: 06/2017/TT-BYT | Hanoi, May 03, 2017 |
CIRCULAR
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”.
Article 1. Scope
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.
Article 2. 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
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;
b) Teratogenicity or Developmental toxicity;
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.
Article 5. Effect
This Circular takes effect as from July 01, 2017.
Article 6. Transition provision
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.
Difficulties that arise during the implementation of this Circular should be promptly reported to the Drug Administration of Vietnam (affiliated to Ministry of Health) for consideration./.
| PP MINISTER |
LIST
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 |
1 | Abiraterone | Oral administration: various forms |
2 | Valproic acid | Oral administration: various forms; Intravenous administration: various forms |
3 | Anastrozole | Oral administration: various forms |
4 | Arsenic trioxide | Intravenous administration: various forms |
5 | Atracurium besylate | Intravenous administration: various forms |
6 | Atropine sulfate | Intravenous administration: various forms |
7 | Azacitidine | Intravenous administration: various forms |
8 | Bicalutamide | Oral administration: various forms |
9 | Bleomycin | Intravenous administration: various forms |
10 | Bortezomib | Intravenous administration: various forms |
11 | Botulinum toxin | Intravenous administration: various forms |
12 | Bupivacaine | Intravenous administration: various forms |
13 | Capecitabine | Oral administration: various forms |
14 | Carbamazepine | Oral administration: various forms |
15 | Carboplatin | Intravenous administration: various forms |
16 | Carmustine | Intravenous administration: various forms |
17 | Cetrorelix | Intravenous administration: various forms |
18 | Chlorambucil | Oral administration: various forms |
19 | Choriogonadotropin alfa | Intravenous administration: various forms |
20 | Cisplatin | Intravenous administration: various forms |
21 | Colistin | Intravenous administration: various forms |
22 | Conjugated Oestrogens | Oral administration: various forms |
23 | Cyclophosphamide | Oral administration: various forms; Intravenous administration: various forms |
24 | Cyclosporin | Oral administration: various forms |
25 | Cytarabine | Intravenous administration: various forms |
26 | Dacarbazine | Intravenous administration: various forms |
27 | Dactinomycin | Intravenous administration: various forms |
28 | Daunorubicin | Intravenous administration: various forms |
29 | Degarelix | Intravenous administration: various forms |
30 | Desflurane | Volatile liquid |
31 | Dexmedetomidine | Intravenous administration: various forms |
32 | Docetaxel | Intravenous administration: various forms |
33 | Doxorubicin | Intravenous administration: various forms |
34 | Entecavir | Oral administration: various forms |
35 | Epirubicin | Intravenous administration: various forms |
36 | Erlotinib | Oral administration: various forms |
37 | Estradiol | Intravenous administration: various forms |
38 | Etoposide | Oral administration: various forms; Intravenous administration: various forms |
39 | Everolimus | Oral administration: various forms |
40 | Exemestane | Oral administration: various forms |
41 | Fludarabine | Intravenous administration: various forms |
42 | Fluorouracil (5-FU) | Intravenous administration: various forms |
43 | Flutamide | Oral administration: various forms |
44 | Fulvestrant | Intravenous administration: various forms |
45 | Ganciclovir | Intravenous administration: various forms |
46 | Ganirelix | Intravenous administration: various forms |
47 | Gefitinib | Oral administration: various forms |
48 | Gemcitabine | Intravenous administration: various forms |
49 | Goserelin | Intravenous administration: various forms |
50 | Halothan | Volatile liquid |
51 | Hydroxyurea | Oral administration: various forms |
52 | Ifosfamide | Intravenous administration: various forms |
53 | Imatinib | Oral administration: various forms |
54 | Irinotecan | Intravenous administration: various forms |
55 | Isoflurane | Volatile liquid |
56 | Lenalidomide | Oral administration: various forms |
57 | Letrozole | Oral administration: various forms |
58 | Leuprorelin (also known as Leuprolide) | Intravenous administration: various forms |
59 | Levobupivacaine | Intravenous administration: various forms |
60 | Medroxy progesterone acetate | Intravenous administration: various forms |
61 | Menotropin | Intravenous administration: various forms |
62 | Mepivacaine | Intravenous administration: various forms |
63 | Mercaptopurine | Oral administration: various forms |
64 | Methotrexate | Oral administration: various forms; Intravenous administration: various forms |
65 | Methyltestosterone | Oral administration: various forms |
66 | Mitomycin C | Intravenous administration: various forms |
67 | Mitoxantrone | Intravenous administration: various forms |
68 | Mycophenolate | Oral administration: various forms |
69 | Neostigmine methylsulfate | Intravenous administration: various forms |
70 | Nilotinib | Oral administration: various forms |
71 | Octreotide | Intravenous administration: various forms |
72 | Oxaliplatin | Intravenous administration: various forms |
73 | Oxcarbazepine | Oral administration: various forms |
74 | Oxytocin | Intravenous administration: various forms |
75 | Paclitaxel | Intravenous administration: various forms |
76 | Pamidronate disodium | Oral administration: various forms; Intravenous administration: various forms |
77 | Pancuronium bromide | Intravenous administration: various forms |
78 | Pazopanib | Oral administration: various forms |
79 | Pemetrexed | Intravenous administration: various forms |
80 | Pipecuronium bromide | Intravenous administration: various forms |
81 | Procaine hydrocloride | Intravenous administration: various forms |
82 | Progesterone | Intravenous administration: various forms |
83 | Propofol | Intravenous administration: various forms |
84 | Pyridostigmine bromide | Intravenous administration: various forms |
85 | Ribavirin | Oral administration: various forms; Intravenous administration: various forms |
86 | Rocuronium bromide | Intravenous administration: various forms |
87 | Ropivacaine | Intravenous administration: various forms |
88 | Sevoflurane | Volatile liquid |
89 | Sirolimus | Oral administration: various forms |
90 | Sorafenib | Oral administration: various forms |
91 | Sunitinib | Oral administration: various forms |
92 | Suxamethonium chloride | Intravenous administration: various forms |
93 | Tacrolimus | Oral administration: various forms; Intravenous administration: various forms |
94 | Talniflumat | Oral administration: various forms |
95 | Tamoxifen | Oral administration: various forms |
96 | Temozolomide | Oral administration: various forms |
97 | Testosterone | Oral administration: various forms; Intravenous administration: various forms |
98 | Thalidomide | Oral administration: various forms |
99 | Thiopental | Intravenous administration: various forms |
100 | Thiotepa | Intravenous administration: various forms |
101 | Thymosin alpha I | Intravenous administration: various forms |
102 | Topotecan | Oral administration: various forms; Intravenous administration: various forms |
103 | Triptorelin | Intravenous administration: various forms |
104 | Tritenoin (All-Trans Retinoic Acid) | Oral administration: various forms |
105 | Valganciclovir | Oral administration: various forms |
106 | Vecuronium bromide | Intravenous administration: various forms |
107 | Vinblastine | Intravenous administration: various forms |
108 | Vincristine | Intravenous administration: various forms |
109 | Vinorelbine | Intravenous administration: various forms |
110 | Zidovudine | Oral administration: various forms |
111 | Ziprasidone | Oral administration: various forms |
* The List includes salts of substances mentioned in the foregoing table in case they are formed and exist./.