Nội dung toàn văn Decision No. 37/2008/QD-BYT promulgation of list of rare medicines only available on request
MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No. 37/2008/QD-BYT | Hanoi, November 20, 2008 |
DECISION
PROMULGATION OF LIST OF RARE MEDICINES ONLY AVAILABLE ON REQUEST
THE MINISTRY OF FINANCE
Pursuant to the Government's Decree No. 188/2007/ND-CP dated December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Law on Pharmacy No. 34/2005/QH11 dated June 14, 2005;
Pursuant to the Prime Minister’s Decision No. 151/2007/QD-TTg dated September 12, 2007 of the Prime Minister on import of medicines that have not had registration numbers in Vietnam;
At the request of Director of Drug Administration of Vietnam,
DECIDES THAT:
Article 1. The list of rare medicines is promulgated together with this Decision.
Article 2. This Decision takes effect after 15 days from the day on which it is published on the Official Gazette.
Article 3. The Chief of the Ministry Office. the Chief Inspector, Director of Drug Administration of Vietnam, heads of units affiliated to the Ministry, Director of Services of Health are responsible for the implementation of this Decision./.
| PP THE Minister |
LIST
RARE MEDICINES ONLY AVAILABLE ON REQUEST
(Promulgated together with the Decision No. 37/2008/QD-BYT dated November 20, 2008 of the Minister of Health)
I. PURPOSE
In consideration of the conditions of medical facilities nationwide which are in the need for some medicines that are not available in Vietnam serving a limited number of patients or some medical techniques that have not been widely applied in Vietnam. In order to enable patients to have the medicines they need, the Ministry of Health promulgates a List of rare medicines.
II. RULES AND CRITERIA FOR COMPILING THE LIST OF RARE MEDICINES:
1. Rules:
- The use of the List of rare medicines shall be instructed in relevant documents.
- The list of rare medicines shall be adjusted periodically.
2. Criteria for selection:
A medicine in the List of rare medicine has to satisfy all of the criteria below:
- The medicine is not available in Vietnam (with regard to formula, concentration, and route of administration). There is not any similar medicine registered in Vietnam or there is a similar medicine that has a registration number but it is not sold or its supply is not sufficient.
- The medicine is used for a number of limited patients (inpatients or outpatients).
- The medicine is requested by medical facilities.
- The medicine is not on the list of Medicines not recommended by WHO.
- The medicine has be manufactured and used in one of member States of International Conference Harmonization (including: USA, Europe, Japan) or in one of the member State of Pharmaceutical Inspection Cooperation Scheme (PICs).
III. LIST OF RARE MEDICINES
No. | Active ingredient | Route of administration and/or dosage form and/or concentration |
1 | Acenocoumarol | Oral administration: Various forms |
2 | Acetazolamide | Injection: Powder for solution for injection Oral administration: Various forms |
3 | Acetylcysteine | Injection: Solution for infusion |
4 | Aciclovir | Injection: Powder for solution for infusion |
5 | Acitretin | Oral administration: Various forms |
6 | Altretamin | Oral administration: Various forms |
7 | Amitriptyline chlorhydrate | Oral administration: Various forms: Orally administered solution |
8 | Amphotericin B | Injection: Solution for injection |
9 | Anetholtrihion | Oral administration: Various forms |
10 | Anti-D immunoglobuline human | Injection: Powder for solution for injection |
11 | Apomorphine | Oral administration: Various forms |
12 | Aprotinin | Injection: Solution for infusion |
13 | Atenolol | Injection: Solution for infusion |
14 | Atropin | Injection: Solution for injection 1mg/ml Eye drops: 1% solution |
15 | Azathioprin | Oral administration: Various forms |
16 | Bacteries BCG | Injection: Solution for injection |
17 | Betamethasone | Oral administration: oral drops Injection: Solution for injection; mixture for injection |
18 | Betaxolol | Eye drops |
19 | Bromocriptin | Oral administration: Various forms |
20 | Buspirone chlorhydrate | Oral administration: Various forms |
21 | Busulfan | Oral administration: Various forms |
22 | Coagulation factor II, VII, VIII, IX, X | Injection: various forms (as a single substance or combined with other elements) |
23 | Calcipotriol | Topical administration: Topical cream |
24 | Calcium chloride | Injection: 10% solution for infusion |
25 | Carbidopa | Oral administration: breakable tablets |
26 | Cefoxitin | Injection: Powder for solution for intravenous injection |
27 | Celiprolol | Oral administration: Various forms |
28 | Cethexonium bromide | Eye drops |
29 | Chlorpromazine | Injection: Solution for injection Oral administration: oral drops |
30 | Cibenzoline | Oral administration: Various forms |
31 | Clofazimine | Oral administration: Various forms |
32 | Clomipramine | Oral administration: Various forms |
33 | Clonazepam | Oral administration: Various forms Injection: Solution for injection |
34 | Clonidine | Injection: Solution for injection Oral administration: Various forms |
35 | Codeine | Oral administration: Syrup |
36 | Cholestyramine | Oral administration: Powder pack |
37 | Colistin (Colimycin) | Injection: Solution for injection Oral administration: Various forms |
38 | Corticorelin | Hypothalamus hormone diagnosis |
39 | Cortivazol | Injection: mixture for injection |
40 | Cromolyn sodium (Cromoglicate de Na) | Injection, oral administration, spray, intravitreal administration |
41 | Cyclopentolate | Eye drops: diagnostic solution |
42 | Dacarbazine | Injection: Powder for solution for infusion |
43 | Dantrolene | Oral administration: tablets Injection: Lyophilized powder for solution for injection |
44 | Dapson | Oral administration: tablets (as a single substance or combined with other elements) |
45 | Desmopressin | Spray |
46 | Dexamethason + Oxytetracyclin + Polymyxin + Nystatin | Topical administration: Ear spray |
47 | Dexchlorpheniramine maleate | Injection: Solution for injection |
48 | Diethylcarbamazin | Oral administration: Various forms |
49 | Digitoxin | Oral administration: Various forms |
50 | Digoxin | Injection: Solution for intravenous injection Oral administration: Orally administered solution |
51 | Dihydroergotamin | Oral administration: tablets |
52 | Diltiazem | Injection: Solution for injection |
53 | Dimercaprol | Injection: Solution for intramuscular injection (as a single substance or combined with other elements) |
54 | Dinoproston | Suppository: sterile vaginal gel, pre-filled syringe |
55 | Dipyridamol | Injection: Solution for injection Oral administration: Various forms |
56 | Dorzolamide | Eye drops: eye ointment, intravitreal solution |
57 | Droperidol | Injection: Solution for injection |
58 | Ephedrine | Injection: Solution for injection |
59 | Eptifibatide | Injection: Solution for injection |
60 | Ergotamin | Oral administration: tablets (as a single substance or combined with other elements) |
61 | Erythromycin lactobionate | Injection: Powder for solution for infusion |
62 | Esmolol chlorhydrate | Injection: Solution for injection |
63 | Estradiol | Transdermal patch |
64 | Etoposide | Oral administration: Various forms |
65 | Exemestan | Oral administration: Various forms |
66 | Fibrinogen | Injection: Powder for solution for injection (as a single substance or combined with other elements) |
67 | Filgrastim | Injection: Solution for injection |
68 | Flecainide acetate | Solution for injection; Oral administration: Various forms |
69 | Fludrocortison acetate + lidocain clorhydrat + polymyxin | Ear drops |
70 | Fluindioin | Oral administration: Various forms |
71 | Flunitrazepam | Oral administration: Various forms |
72 | Fluorescein | Eye drops Injection: Solution for intravenous injection |
73 | Recombinant follitropin alpha/ Follitropin beta | Injection: subcutaneous injection, intravenous injection |
74 | Fosfomycin trometamol | Oral administration: granules for oral solution |
75 | Fosphenyltoin | Injection: Solution for injection |
76 | Fuller 's Earth (Clay) | Oral administration: Various forms |
77 | Fusidic Acid | Oral administration: Various forms |
78 | Glatiramer | Injection: Powder for solution for injection |
79 | Glucose 1-phosphat di Natri tetrahydrat | Injection: Solution for infusion |
80 | Halofantrin hydrochloride | Oral administration: tablets |
81 | Haloperidol | Oral administration: oral drops |
82 | Calcium heparinate | Injection: Solution for injection |
83 | Human Chorionic Gonadotropin (HCG) | Injection: intramuscular injection, lyophilized powder tube |
84 | Human Menotropin Gonadotropin (HMG) | Injection: intramuscular injection, lyophilized powder tube |
85 | Snake antivenom serum (various type) | Injection: Solution for injection |
86 | Hydralazine | Injection: Solution for injection Oral administration: Various forms |
87 | Hydroxycarbamide | Oral administration: Various forms |
88 | Hydroxychloroquine | Oral administration: Various forms |
89 | Hydroxyzine | Injection: Solution for injection; |
90 | Indometacin | Suppository |
91 | Interferon bêta-1a | Injection: Various forms |
92 | Interferon bêta-1b | Injection: Various forms |
93 | Iohexol | Injection: Solution for injection (for diagnosis) |
94 | Iopamidol | Injection: Solution for injection |
95 | Ipratropi bromide | Nose spray |
96 | Isoprenaline | Injection: Solution for injection Oral administration: Various forms |
97 | Isosorbid | Injection: Solution for intravenous injection |
98 | Ivermectin | Oral administration: Various forms |
99 | Josamycin | Oral administration: Various forms |
100 | Potasium chloride | Injection: Solution for injection Oral administration: Orally administered solution |
101 | Potasium iodide | Oral administration: Orally administered solution |
102 | Labetalol | Injection: Solution for injection Oral administration: Various forms |
103 | Lauromacrogol 400 (Polidocanol, Aetoxisclerol) | Injection: Solution for injection |
104 | L-Cystin; Soufre precipit … | Oral administration: tablets for solution |
105 | Leucovorin | Injection: intravenous injection; |
106 | Levonorgestrel | Intrauterine suppository |
107 | Linsidomin | Injection: Lyophilized powder for solution for injection |
108 | Lorazepam | Oral administration: Various forms |
109 | Loxapin | Injection: Solution for injection Oral administration: Various forms |
110 | Levothyroxine | Oral administration: tablets |
111 | Magnesi sulfate | Injection: Solution for intravenous injection |
112 | Magnesium chloride | Injection: 10% solution for injection |
113 | Mangan glycerophosphate + Ammoni dihydrogenophosphate | Oral administration: Effervescent tablet |
114 | Mechlorethamine | Injection: Various forms |
115 | Mecophenolate mofetil | Injection: Solution for intravenous injection |
116 | Medroxyprogesteron | Oral administration: Various forms |
117 | Mefloquine | Oral administration: Various forms |
118 | Meladinine (Methoxsalen) | Topical administration |
119 | Melphalane | Oral administration: Various forms |
120 | Mercaptopurine | Oral administration: Various forms |
121 | Mesalazine | Oral administration: Various forms Rectal enema, rectal suppository; emulsion |
122 | Methylergometrine | Oral administration: Orally administered solution Injection: Solution for injection |
123 | Metoclopramide | Oral drops: 0.1 mg per drop |
124 | Mexiletine | Injection: Various form; |
125 | Milrinon | Injection: Solution for intravenous injection |
126 | Mitoxantron | Injection: Solution for injection |
127 | Molsidomin | Oral administration: tablets |
128 | Montelukast | Oral administration: 5mg tablets |
129 | Morniflumate | Rectal suppository |
130 | Morphine sulfate | Oral administration: Extended-release capsule |
131 | Nalbuphin | Injection: Solution for injection |
132 | Naloxon | Injection: Solution for injection |
133 | Sodium bicarbonat | Injection: 1.4%, 8.4% solution for injection |
134 | Sodium calcium edetate (E.D.T.A) | Injection: Solution for injection |
135 | Sodium chloride (NaCl) | Injection: 0.9% solution for injection in 250ml/500ml/1000ml plastic bag; 20% solution for injection in 10ml tube; 10% solution |
136 | Sodium thiosulfate | Injection: 25% solution for injection |
137 | Nelfinavir | Oral administration: Various forms |
138 | Nicardipin | Oral administration: Various forms Injection: Solution for intravenous injection |
139 | Nilutamid | Oral administration: Various forms |
140 | Nitroglycerin | Transdermal patch Injection: Solution for injection Spray solution Sublingual tablets |
141 | Nitroprussiat | Injection: Powder for solution for injection |
142 | Octreotid | Injection: Solution for injection |
143 | Oxybuprocain | Eye drops |
144 | Papaverin | Injection: Solution for injection |
145 | Acid Para-aminobenzoic | Oral administration: Various forms |
146 | Paroxetin | Oral administration: Various forms |
147 | Pemirolast | Eye drops |
148 | Penicillamin | Oral administration: Various forms |
149 | Permethrin | Topical administration: Various forms |
150 | Phenylephrin | Eye drops: solution |
151 | Phenytoin | Injection: Solution for injection |
152 | Phloroglucinol | Injection: Solution for injection |
153 | Phytomenadion | Oral administration: oral emulsion, tablets |
154 | Pilocarpine | 1%, 2% eye drop solution |
155 | Podophyllotoxin | Topical administration: Topical solution |
156 | Polystyrene sulfonate | Oral administration: powder for oral solution Rectal enema: mixture |
157 | Praziquantel | Oral administration: Various forms |
158 | Prednisolon + Naphazolin | Nose spray |
159 | Pristinamycin | Oral administration: Various forms |
160 | Procain chlohydrate | Injection: Solution for injection |
161 | Procarbazine | Oral administration: Various forms |
162 | Promegeston | Oral administration: Various forms |
163 | Propafenon | Oral administration: Various forms |
164 | Propranolol | Injection: Solution for injection |
165 | Protamine | Injection: Solution for injection |
166 | Quinidine | Oral administration: Various forms |
167 | Quinine | Injection: Solution for injection Oral administration: as a single substance or combined with Thiamin |
168 | Raubasine dihydroergocristine | Injection: Solution for injection |
169 | Retinol | Eye drops: eye ointment |
170 | Salbutamol | Injection: Solution for injection Suppository |
171 | Selegiline | Oral administration: Various forms |
172 | Somatropin | Injection: Lyophilized powder for solution for injection |
173 | Sotalol | Injection: Solution for intravenous injection Oral administration: Various forms |
174 | Sufentanil | Injection: Solution for injection |
175 | Sulfamethoxazol 400mg + Trimethoprim 80mg | Injection: Solution for infusion |
176 | Sulfasalazin | Oral administration: Various forms |
177 | Sulproston | Injection: Lyophilized powder for solution for injection |
178 | Sumatriptan | Injection: Solution for injection |
179 | Sunitinib | Oral administration: Various forms |
180 | Terbutaline | Injection: Solution for injection |
181 | Tetracaine | Eye drops: solution |
182 | Tetracosactide | Injection: mixture intravenous injection, intramuscular injection |
183 | Tetrazepam | Oral administration: Various forms |
184 | Tiapride | Injection: Solution for injection |
185 | Tioguanin (6-Thioguanin) | Oral administration: Various forms |
186 | Topiramate | Oral administration: Various forms |
187 | Topotecane | Injection: Powder for solution for infusion |
188 | Triclabendazole | Oral administration: Various forms |
189 | Trientine | Injection: Various form; |
190 | Trihexyphenidyl | Oral administration: solution, tablets |
191 | Tropatepine | Oral administration: Various forms |
192 | Trospium | Oral administration: Various forms |
193 | Urapidil | Injection: Solution for injection |
194 | Valaciclovir | Oral administration: Various forms |
195 | Valproic Acid | Injection: Powder for solution for injection |
196 | Sterile vaseline | Sterile vaseline (used for surgery and endotracheal intubation) |
197 | Verapamil | Injection: Solution for injection; |
198 | Vigabatrin | Oral administration: Various forms |
199 | Warfarin | Oral administration: Various forms |
200 | Methylene blue | Injection: Solution for injection |
201 | Zidovudin | Injection: Solution for injection; |
202 | Zopiclon | Oral administration: Various forms |
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