Circular No. 23/2014/TT-BYT promulgation of list of otc drugs đã được thay thế bởi Circular 07/2017/TT-BYT promulgation of List of OTC drugs và được áp dụng kể từ ngày 01/07/2017.
Nội dung toàn văn Circular No. 23/2014/TT-BYT promulgation of list of otc drugs
MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No. 23/2014/TT-BYT | Hanoi, June 30, 2014 |
CIRCULAR
PROMULGATION OF LIST OF OTC DRUGS
Pursuant to the Law on Pharmacy No. 34/2005-QH-11 dated June 14, 2005;
Pursuant to the Government's Decree No. 79/2006/ND-CP dated August 09th 2006, specifying the implementation of a number of articles of the Law on Pharmacy;
Pursuant to the 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;
At the request of the Director of Drug Administration of Vietnam,
The Minister of Health promulgates a Circular on promulgation of the list of OTC drugs
Article 1. The list of OTC drugs is promulgated together with this Circular, including:
1. A list of modern medicines.
2. A list of oriental medicines.and herbal medicines.
Article 2. Interpretation of terms
1. OTC drugs are drugs that are dispensed, sold, and used without prescriptions.
2. Prescription drugs are drugs that may threaten the health or life of users if they fail to comply with instructions of the prescribers, and require a medical prescription before they are disposed, retailed, or used for outpatients.
Article 3. Rules for compiling the List of OTC drugs
1. The List of OTC drugs is complied according to specific criteria for pharmacological properties and safety of drugs.
2. The List of OTC drugs is appropriate for the actual use and supply of drugs in Vietnam, with reference to classification of OTC drugs of other countries.
3. The List of OTC drugs shall be adjusted to the actual use and supply of drugs. If necessary, to ensure safety of users, some drugs may be removed from the list of OTC drugs if their serious harmful effects are found.
Article 4. Criteria for selection of OTC drugs
A drugs that satisfy all criteria below shall be put on the List of OTC drugs:
1. Any drug with low toxicity, does not create toxic degradation products, does not have serious harmful effects (which may cause death, threaten life, need hospitalization or prolonged treatment, cause permanent or serious impairments, congenital abnormalities, congenital malformations, and similar consequences) that are known or warned against.
2. The dosage range is wide and safe for various age groups, does not significantly affect the diagnosis and treatment of diseases that need clinical monitoring.
3. Drugs indicated to treat common diseases which can be treated by patients themselves without examination, monitoring, and consultation from physicians.
4. Drugs of which the administration routes and dosage forms are simple (oral, topical administration), and the concentration are appropriate for self-treatment.
5. Drugs that rarely interact with other drugs or common foods and drinks.
6. Drugs that do not cause dependence.
Article 5. Application of the List of OTC drugs
1. The List of OTC drugs is the basis for separating OTC drugs and prescription drugs.
2. The List of OTC drugs is the legal basis for formulation and promulgation of regulations and instructions on registration, manufacture, export, import, distribution, advertising of OTC drugs, and the scope of drug retailers.
3. Health workers must provide instructions on the use contraceptive drugs classified as OTC drugs when they are dispensed or sold to users.
Article 6. Implementation
1. Drug retailers:
From the effective date of this Circular, drug retailers may retail the OTC drugs in the List enclosed herewith.
2. Drug manufacturers and distributors:
a) With regard to applications for drug sale in Vietnam and application for drugs import without registration numbers that are submitted to Drug Administration of Vietnam before this Circular takes effect, the applicants must classify and revise documents pertaining to drug classification in accordance with this Circular before obtaining the registration numbers or import permits.
b) With regard to drugs that have registration numbers or import permits before this Circular takes effect:
- Within 12 months from the effective date of this Circular, drugs may be manufactured, imported, and sold on the market until their expiry dates with the approved labels and classifications.
- After 12 months from the effective date of this Circular, the labels, instruction sheets must be classified and updated with information about drug classification prescribed in this Circular before they can be sold on the market.
3. Drug Administration of Vietnam, units affiliated to the Ministry of Health, Services of Health, Vietnam Pharmaceutical Corporation, manufacturers, sellers of medicinal products, foreign companies licensed to do pharmaceutical business are responsible for the implementation of this Circular.
Article 7. Implementation
1. This Circular takes effect on August 15, 2014.
2. When the documents referred to in this Circular are replaced or amended, the newer ones shall apply.
3. The Circular No. 08/2009/TT-BYT dated July 01, 2009 of the Minister of Health on promulgation of the List of OTC drugs is annulled from the effective date of this Circular./.
| MINISTER |
OTC DRUG LIST
1. Modern medicines
No. | Active ingredients | Administration route, dosage form, concentration limit | Other regulations |
1 | Acetylcystein | Oral administration: various form |
|
2 | Acetylleucin | Oral administration: various form |
|
3 | Acetylsalicylic acid (Aspirin), as a single substance or combined with Vitamin C and/or citric acid and/or sodium bicarbonate and/or sodium salicylate | Oral administration: various form | Indication: pain relief, fever relief, anti-inflammation |
4 | Alginic acid (Sodium Alginat) as a single substance or combined with compounds of aluminum, magnesium | Oral administration: various form |
|
5 | Amino acid as a single substance or combined with other substances (including combinations with vitamins) | Oral administration: various form | Indications: supplementation of amino acids and vitamins |
6 | Aminobenzoic acid (para aminobenzoic acid) | Oral administration: various form |
|
7 | Benzoic acid as a single substance or combined with other substances | Topical administration Oral administration: lozenges |
|
8 | Boric acid as a single substance or combined with other substances | Topical administration Intravitreal administration |
|
9 | Acid citric combined with sodium, potassium salts | Oral administration: various form |
|
10 | Acid cromoglicic and various forms of cromoglicat salts | Intravitreal administration, nasal administration with ≤ 2% of cromoglicic acid |
|
11 | Dimecrotic acid | Oral administration: various form |
|
12 | Folic acid as a single substance or combined with iron and/or B Vitamins, minerals, sorbitol | Oral administration: various form | Indication: anaemia treatment, nutritional supplements |
13 | Glycyrrhizinic acid (Glycyrrhizinat) combined with other active ingredients such as chlorpheniramin maleat, Dl-methylephedrin, Cafein, etc. | Oral administration: various forms, including lozenges Topical administration |
|
14 | Lactic acid as a single substance or combined with other substances | Topical administration |
|
15 | Mefenamic acid | Oral administration: various form |
|
16 | Salicylic acid as a single substance or combined with Lactic acid; precipitated sulfur, etc. in topical products | Topical administration |
|
17 | Acyclovir | Topical administration: skin cream with Acyclovir concentration ≤ 5% |
|
18 | Albendazole | Oral administration: various form | Vermifuge |
19 | Alcol diclorobenzyl combined with other substances in lozenges | Oral administration: lozenges |
|
20 | Alcol polyvinyl | Topical administration |
|
21 | Alimemazin tartrat (Trimeprazin tartrat) | Oral administration: various form |
|
22 | Allantoin combined with other substances in topical products, rectal suppositories (cepae fluid, etc) | Topical administration Rectal suppositories |
|
23 | Allatoin combined with Vitamins and/or Chondroitin | Intravitreal administration |
|
24 | Almagat | Oral administration: various form |
|
25 | Ambroxol as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers | Oral administration: various form with the following limits: - Divided dose: Ambroxol chlorhydrate ≤ 30mg/unit - Undivided dose: Ambroxol chlorhydrate ≤ 0.8% |
|
26 | Amyllase as a single substance or combined with Protease and/or Lipase and/or Cellulase | Oral administration: various form |
|
27 | Amylmetacresol combined with essential oil, Bacitracin, etc. in lozenges | Oral administration: lozenges |
|
28 | Argyron | Intravitreal administration Topical administration |
|
29 | Aspartam | Oral administration: various form |
|
30 | Aspartat as a single substance or combined with other substances | Oral administration: various form |
|
31 | Attapulgit | Oral administration: various form |
|
32 | Azelastin | Intravitreal administration, nasal administration |
|
33 | Sulphadiazin silver | Topical administration |
|
34 | Bacitracin combined with some active ingredients in lozenges (Neomycin sulfat; Amylocain; Tixocortol, etc.) | Oral administration: lozenges |
|
35 | Beclomethason dipropionate | Nasal administration: aerosol with maximum dose of 400 mcg per day, ≤ 200 doses per package (no-salt active ingredients) |
|
36 | Benzalkonium combined with Cholin; acid salicylic; Nystatin; Diiodohydroxyquin , etc. in topical products, or combined with Tyrothricin, Bacitracin, essential oil, etc.in lozenges | Topical administration Lozenges |
|
37 | Benzocain combined with other substances | Topical administration: various forms with Benzocain ≤ 10%; Rectal suppositories Oral administration: lozenges |
|
38 | Benzoyl peroxid as a single substance or combined with Iod and/or sulfur | Topical administration: various forms with concentration ≤ 10% |
|
39 | Benzydamin HCl as a single substance or combined with other substances | Topical administration: oral mucosa cream mouthwash, oral spray Oral administration: lozenges |
|
40 | Benzydamin salicylate as a single substance or combined with other substances | Topical administration |
|
41 | Benzyl benzoat combined with essential oil, Isopropyl, etc. in topical products | Topical administration: various form Transdermal patch |
|
42 | Berberin | Oral administration: various form |
|
43 | Biclotymol as a single substance or combined with Enoxolon and/or Phenylephrin HCl and/or Clorpheniramin maleat and/or essential oil | Topical administration Nasal administration Oral administration: lozenges |
|
44 | Bifonazol as a single substance or combined with Urea | Topical administration |
|
45 | Bisacodyl | Oral administration: divided dose with concentration ≤ 10 mg/unit |
|
46 | Bismuth salt | Oral administration: various form |
|
47 | Boldin | Oral administration: various form |
|
48 | Bromelaas a single substance or combined with Trypsin | Oral administration: various form |
|
49 | Bromhexin HCl as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers | Oral administration: various form with limited Bromhexin HCl content: - Divided dose: ≤ 8 mg/unit - Undivided dose: ≤ 0.8% Rectal suppositories |
|
50 | Brompheniramin maleat as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers | Oral administration: various form |
|
51 | Budesonid | Nasal administration: aerosol, inhaler, powder for snorting with limited dose of 400 mcg per day, ≤ 200 doses per package |
|
52 | Bufexamac as a single substance or combined with Titan Dioxid, Bismuth, Subgallat, Lidocain, etc. in topical products or rectal suppositories | Topical administration Rectal suppositories |
|
53 | Butoconazol | Topical administration |
|
54 | Caffeine combined with active ingredients on this list | Oral administration: various form |
|
55 | Calamin as a single substance or combined with topical products | Topical administration |
|
56 | Calcium (including compounds) single ingredient or combined with Vitamin D (except Calcitriol) and/or Vitamins and/or Ipriflavon | Oral administration: various form | Indications: supplementation of calcium |
57 | Carbinoxamine as a single substance or combined with Pseudoephedrin HCl and/or Bromhexin and/or Paracetamol in cough medicines, antipyretic drugs, pain relievers | Oral administration | Products that contain Pseudoephedrin must comply with regulations applied to drugs that contain Pseudoephedrin (No. 216 of this List) |
58
| Carbocystein | Oral administration: various form |
|
59 | Carbomer | Topical administration Intravitreal administration |
|
60
| Catalase as a single substance or combined with Neomycin in topical products | Topical administration |
|
61 | Cetirizin dihydroclorid | Oral administration: various form |
|
62 | Cetrimid combined with some active ingredients in topical products (Lidocain, Zinc, Calamine, Aminacrine, essential oil, etc.) | Topical administration |
|
63 | Cetrimonium in combined with other substances in topical products, lozenges (with Lidocain; Tyrothricin, essential oil, etc.) | Topical administration Oral administration: lozenges |
|
64 | Chitosan (Polyglusam) | Topical administration |
|
65 | Cholin as a single substance or combined with amino acids, Vitamins in orally administered products; combined with Salicylic acid, Benzalkonium, etc. in topical products | Oral administration: various form Topical administration |
|
66 | Chondroitin as a single substance or combined with Glucosamin and/or fish oil and/or Vitamins and/or amino acids | Oral administration: various form
|
|
67 | Chondroitin as a single substance or combined with Borneol and/or Vitamins | Intravitreal administration Topical administration |
|
68 | Ciclopirox olamin | Topical administration |
|
69 | Cimetidin | Oral administration: divided dose with Cimetidin ≤ 200 mg/unit |
|
70 | Cinarizin | Oral administration: various form |
|
71 | Cinchocain in combined with Hydrocortison, Neomycin, Esculin, etc. in topical products, rectal suppositories | Topical administration Rectal suppositories |
|
72 | Citrullin | Oral administration: various form |
|
73 | Clobetasone butyrate | Topical administration |
|
74 | Chlorhexidine | Topical administration |
|
75 | Chlorophyll | Oral administration: various form |
|
76 | Chlorpheniramine maleate as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers | Oral administration: various form Divided dose: Chlorpheniramine maleate ≤ 4 mg/unit. |
|
77 | Chlorpheniramine maleate combined with Chondroitin and/or Vitamins | Intravitreal administration |
|
78 | Clotrimazole | Topical administration: various forms with concentration ≤ 3% Vaginal suppositories |
|
79 | Codein combined with active ingredients on this list for the purpose of cough treatment, fever reduction, or pain relief | Oral administration: various form with the following limits on Codeine content (bases): - Divided dose: ≤ 12 mg/unit - Undivided dose: ≤ 2.5% | Not more than 10 days’ dose of products that contain Codeine may be sold without prescription. Retailers must record buyers’ names and addresses. |
80 | Coenzym Q10 as a single substance or combined with Vitamins | Oral administration: various form |
|
81 | Crotamiton | Topical administration |
|
82 | Dequalinium as a single substance or combined with Tyrothricin; Hydrocortison; acid Glycyrrhetinic; Lidocain, etc. in topical products and lozenges | Topical administration Vaginal suppositories Oral administration: lozenges |
|
83 | Desloratadin | Oral administration: concentration ≤ 5 mg/divided dose |
|
84 | Dexbrompheniramine maleate as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers | Oral administration: various form |
|
85 | Dexchlorpheniramine maleate as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers | Oral administration: various form |
|
86 | Dexibuprofen | Oral administration: concentration ≤ 400 mg/divided dose |
|
87 | Dexpanthenol | Intravitreal administration Topical administration |
|
88 | Diacerein | Oral administration: various form |
|
89
| Diclofenac as a single substance or combined with Methyl salicylate; substances of essential oil group, etc. | Topical administration Intravitreal administration (single form) |
|
90 | Dicyclomin | Oral administration: various form |
|
91 | Diethylphtalate (DEP) | Topical administration |
|
92 | Dimenhydrinate | Oral administration: various form |
|
93 | Dimethicon (Dimethylpolysiloxan) as a single substance or combined with Guaiazulen | Oral administration: various form |
|
94 | Dimethicon combined with Zinc; Calamin; Cetrimid, etc. in topical products | Topical administration |
|
95 | Dimethinden | Oral administration: various form Topical administration |
|
96 | Disodium Inosin monophosphate | Intravitreal administration |
|
97 | Diosmectit (Dioctahedral smectit) | Oral administration: various form |
|
98 | Diosmin combined with Hesperidin and/or some herbal ingredients that contain Flavonoid | Oral administration: various form |
|
99 | Diphenhydramin hydroclorid or monocitrate | Oral administration: various form with the following concentration limit (bases): - Divided dose: ≤ 50 mg/unit - Undivided dose: ≤ 2.5% |
|
100 | Domperidon | Oral administration: various form with the following limits: - Divided dose: ≤ 10 mg/unit - Undivided dose: ≤ 0.1% |
|
101 | Sulfate copper | Topical administration |
|
102 | Doxylamin combined with Paracetamol, Pseudoephedrin HCl, and other active ingredients on OTC drug list in cough medicines, antipyretic drugs, pain relievers | Oral administration: various form | Products that contain Pseudoephedrin must comply with regulations applied to drugs that contain Pseudoephedrin (No. 216 of this List) |
103 | Econazol as a single substance or combined with Hydrocortison | Topical administration: various forms with Hydrocortison concentration ≤ 0.05% |
|
104 | Enoxolon as a single substance or combined with other ingredients in topical products, lozenges | Topical administration: skin cream, oral mucosa cream, mouthwash Oral administration: lozenges |
|
105 | Ephedrin HCl | Intravitreal administration, nasal administration: ≤ 1% solution ≤ 15 ml/pack | Not more than 3 packs (smallest unit) of products that contain Ephedrine may be sold without prescription each time Retailers must record buyers’ names and addresses. |
106 | Eprazinon | Oral administration: various form |
|
107 | Esdepallethrin combined with Piperonyl, Spregal, essential oil, ingredients of essential oil in topical products | Topical administration |
|
108 | Estradiol as a single substance or combined with Dydrogesteron | Oral administration: various form, divided dose | Contraception |
109 | Ethanol as a single substance or combined with other ingredients hợp | Topical administration (antiseptic alcohol) Oral administration: combined with other ingredients |
|
110 | Ethylestradiol as a single substance or combined with Desogestrel | Oral administration: various form, divided dose | Contraception |
111 | Ethylestradiol as a single substance or combined with Gestodene | Oral administration: various form, divided dose | Contraception |
112 | Ethylestradiol as a single substance or combined with Levonorgestrel | Oral administration: various form, divided dose | Contraception |
113 | Etofenamat | Topical administration |
|
114 | Famotidin | Oral administration: concentration ≤ 20 mg/ divided dose | Not more than 14 days’ dose shall be sold without prescription |
115 | Fenticonazol | Topical administration |
|
116 | Fexofenadin | Oral administration: various form |
|
117 | Flurbiprofen | Lozenges Topical administration Intravitreal administration |
|
118 | Glucosamin as a single substance or combined with Chondroitin and/or Vitamins | Oral administration: various form |
|
119 | Glucose or Dextrose as a single substance or combined with các muối sodium, potassium | Oral administration: various form | For supplementation of sugar or electrolyte |
120 | Glycerin as a single substance or combined with Polysorbate 80 in topical products, eye drops | Topical administration Intravitreal administration |
|
121 | Glycerol combined with herbal extracts | Enema |
|
122 | Guaiphenesin as a single substance or combined with other active ingredients on OTC drug list used for the purpose of cough treatment, fever reduction, pain relief | Oral administration: various form | Products that contain Pseudoephedrin must comply with regulations applied to drugs that contain Pseudoephedrin (No. 216 of this List) |
123 | Hexamidin as a single substance or combined with Cetrimid, Lidocain, Clotrimazol, Catalase | Topical administration |
|
124 | Hexetidin as a single substance or combined with Benzydamin, Cetylpyridinum, Cholin Salicylat, Methyl salicylat, essential oil, etc. | Topical administration: skin cream, mouthwash |
|
125 | Hydrocortison as a single substance or combined with Miconazol, Econazol, Tioconazol, Neomycin | Topical administration: various forms with Hydrocortison concentration ≤ 0.5% |
|
126 | Hydrogen Peroxid as a single substance or combined with Sodium Lauryl sulfat and/or essential oil, etc. | Topical administration |
|
127 | Hydrotalcit | Oral administration: various form |
|
128 | Hydroxypropyl methylcellulose (HPMC) | Intravitreal administration |
|
129 | Hyoscine (Scopolamin) butylbromid as a single substance or combined with Meclizin hydrochlorid | Oral administration: various forms, including chewable tablets Concentration ≤ 20 mg/ divided dose Transdermal patch |
|
130 | Hypromellose as a single substance or combined with Dextran 70 and/or Carbomer | Intravitreal administration: various form |
|
131 | Ibuprofen | Oral administration: concentration ≤ 400 mg/divided dose Topical administration |
|
132 | Ichthammol | Topical administration |
|
133 | Indomethacin | Topical administration 0.1% eye drops |
|
134 | Iodine combined with potassium Iodide and/or Benzoic acid and/or Salicylic acid | Topical administration: with Iodine concentration ≤ 5% |
|
135 | Isoconazol | Topical administration |
|
136 | Isopropyl Methylphenol | Topical administration |
|
137 | Zinc oxid, zinc pyrithione, zinc gluconate, zinc undecylenate as a single substance or combined with other ingredients in topical products | Topical administration |
|
138 | Sulfate zinc | Topical administration Intravitreal administration |
|
139 | Ketoconazol as a single substance or combined with Zinc Pirythione and/or Hydrocortison and/or Trolamine | Topical administration: various forms with ketoconazole concentration ≤ 2% |
|
140 | Ketoprofen | Topical administration |
|
141 | Lactitol | Oral administration: various form |
|
142 | Lactoserum atomisate | Topical administration |
|
143 | Lactulose | Oral administration: various form |
|
144 | L-Carnitin as a single substance or combined with vitamins | Oral administration: various form |
|
145 | Levocetirizin | Oral administration: various form |
|
146 | Levonorgestrel as a single substance or combined with Ethylestradiol | Oral administration: various form | Contraception |
147 | Lidocain as a single substance or combined with other ingredients | Topical administration |
|
148 | Lindan (Benhexachlor, 666, Gamma-BHC) as a single substance or combined with Lidocain | Topical administration: with Lindan concentration ≤ 1% |
|
149 | Loperamide | Oral administration: Loperamide content ≤ 2 mg/divided dose |
|
150 | Loratadin as a single substance or combined with Pseudoephedrin HCl and/or Paracetamol | Oral administration: various form with the following concentration limits (bases): - Divided dose: Loratadin ≤ 10mg/unit; - Undivided dose: Loratadin ≤ 0.1% | Products that contain Pseudoephedrin must comply with regulations applied to drugs that contain Pseudoephedrin (No. 216 of this List) |
151 | Loxoprofen | Oral administration: various form |
|
152 | Lysozym as a single substance or combined with Tocopherol, Nicotinate, Carbazochrom, Inositol Cetylpyridinium, etc. | Oral administration: various form Topical administration
|
|
153 | Macrogol | Oral administration: various form Enema |
|
154 | Magaldrat as a single substance or combined with compounds of aluminum, magnesium, alginic acid (or alginate salts). | Oral administration: various form |
|
155 | Magnesium including salts and compounds of magnesium | Oral administration: various form | Supplementation of magnesium, gastric acid neutralization, laxatives. |
156 | Mangiferin | Topical administration |
|
157 | Mebendazol | Oral administration: various form with the following limits: - Divided dose: ≤ 500 mg/unit - Undivided dose: ≤ 2% |
|
158 | Mebeverin | Divided dose: ≤ 200 mg/unit |
|
159 | Cellulase fongique | Oral administration: various form |
|
160 | Enzymes as a single substance or combined with các vitamins | Oral administration: various form |
|
161 | Menthol combined with other ingredients such as mixtures of essential oil, Methyl Salycilate, etc. | Oral administration: various form Topical administration: various form |
|
162 | Mequinol | Topical administration |
|
163 | Mequitazin | Oral administration: various form Topical administration |
|
164 | Mercurocrom | Topical administration: ≤ 30ml per pack | Not more than 2 packs may be sold without prescription |
165 | Methyl salicylat combined with other ingredients in lozenges, topical products (combined with essential oil, etc.) | Topical administration Transdermal patch Lozenges |
|
166 | Metronidazol | Topical administration |
|
167 | Miconazol | Topical administration Vaginal cream ≤ 2% |
|
168 | Miconazole combined with Hydrocortison | Topical administration Vaginal cream Miconazol ≤2%; Hydrocortison ≤0,05% |
|
169 | Minoxidil | Topical administration: various forms with concentration ≤ 5% |
|
170 | Mometasone | Nasal administration: ≤ 50 mcg/dose, ≤ 200 doses per box; Topical administration |
|
171 | Mupirocin | Topical administration |
|
172 | Myrtol as a single substance or combined with other ingredients in lozenges | Oral administration: various form Topical administration |
|
173 | Naphazolin as a single substance or combined with other ingredients in nasally administered drugs such as Diphenylhydramine and/or Procaine | Nasal administration with Naphazoline concentration ≤ 0.05% |
|
174 | Naphazolin combined with other ingredients in eye drops (Pheniramin; Vitamin glycyrhizinat, Dexpanthenol, etc.) | Nasal administration: various form with Naphazoline concentration ≤ 0.1% |
|
175 | Naproxen | Oral administration: various form with ≤ 275mg/divided dose |
|
176 | Sodium benzoat as a single substance or combined with other ingredients | Oral administration: various form |
|
177 | Sodium bicacbonat as a single substance or combined with other ingredients | Oral administration: various form |
|
178 | Sodium carbonat as a single substance or combined with other ingredients | Oral administration: various form |
|
179 | Sodium Carboxymethylcellulose (Na CMC) | Intravitreal administration |
|
180 | Sodium Chloride as a single substance or combined with Potassium Citrate, Sodium citrate, etc. | Oral administration: various form Topical administration Intravitreal administration, nasal administration with concentration ≤ 0.09% |
|
181 | Sodium Docusat | Oral administration: various form |
|
182 | Sodium Fluorid combined with other ingredients | Topical administration: toothpaste, mouthwash |
|
183 | Sodium Hyaluronat (Hyaluronic acid) | Topical administration |
|
184 | Sodium Monofluorophosphate | Topical administration, including products for cleaning the oral cavity, mucous membrane |
|
185 | Sodium Salicylate combine with other ingredients | Oral administration: combined with other ingredients in lozenges Topical administration |
|
186 | Neomycin sulfate combined with other ingredients in lozenges (Zinc; Bacitracin; Amylocaine, etc.), topical products | Oral administration: lozenges Topical administration |
|
187 | Trace elements: chrome, copper, potassium, magnesium, manganese, zinc, etc. as a single substance or combined with other ingredients, including vitamins | Oral administration: various form | Supplementation of minerals |
188 | Aluminum, magnesium, calcium, and compounds thereof as a single substance or combined with other ingredients | Oral administration: various form | Gastric acid neutralization, treatment for gastric and duodenal ulcer |
189 | Nomahydrated Sodium Sulfide + Saccharomyces Cerevisiae | Oral administration: various form Topical administration |
|
190 | Noscarpin | Oral administration: various form |
|
191 | Nystatin as a single substance or combined with other substances | Topical administration |
|
192 | Omeprazol | Oral administration: divided dose with concentration ≤ 10 mg/unit | Treatment for gastroesophageal reflux disease Not more than 14 days’ dose shall be sold without prescription |
193 | Orlistate | Oral administration: various form |
|
194 | Ossein hydroxyapatite | Oral administration: various form |
|
195 | Oxeladine | Oral administration: various form |
|
196 | Oxomemazine | Oral administration: various form |
|
197 | Oxymetazoline | Nasal administration, nasal administration with concentration ≤ 0.09% |
|
198 | Pancreatin as a single substance or combined with Simethicon and/or enzymes and/or B vitamins and/or Azintamid | Oral administration: various form | . |
199 | Panthenol | Topical administration Intravitreal administration |
|
200 | Paracetamol as a single substance | Oral administration: various form Rectal suppositories | Combinations of paracetamol with other substances are specified in the list |
201 | Paracetamol combined with active ingredients in this List, meant to treat cough, reduce fever, relief pain, prevent allergy
| Oral administration: various form | Combinations that contain active ingredient that have limited concentrations and may be retailed only once must comply with corresponding regulations applied thereto. |
202 | Pentoxyverine | Oral administration: various form |
|
203 | Phenylephrine HCl | Intravitreal administration, nasal administration with concentration ≤ 1% |
|
204 | Phenylephrine HCl combined with other ingredients in topical products (such as Petrolatum sperti yellow; Mineral oil light; Shark liver oil, etc.) | Topical administration | . |
205 | Phenylephrine HCl combined with other ingredients in cough medicines, antipyretic drugs, pain relievers | Oral administration: various form Rectal suppositories |
|
206 | Phospholipid | Oral administration: various form |
|
207 | Picloxydine | Intravitreal administration |
|
208 | Piroxicam | Topical administration: various forms with concentration ≤ 5% |
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209 | Policresulen (Metacresolsulphonic acid-formaldehyde) | Topical administration Rectal suppositories |
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210 | Polyethylen glycol 400 as a single substance or combined with Propylene glycol | Intravitreal administration |
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211 | Polysacharide | Oral administration: various form |
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212 | Polytar as a single substance or combined with other ingredients in topical products (Zinc Pyrithion, etc.) | Topical administration
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213 | Povidone Iodine | Topical administration: various forms (including ≤ 1% mouthwash) Intravitreal administration |
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214 | Promethazin HCl as a single substance or combined with Carbocystein; Paracetamol, etc. in cough medicines, antipyretic drugs, pain relievers | Oral administration: various form with limited promethazine content as follows (bases): - Divided dose: ≤ 12.5 mg/unit - Undivided dose: ≤ 0.1% Topical administration: concentration ≤ 2% |
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215 | Pseudoephedrine HCl combined with Cetirizine | Oral administration: various form with limited Pseudoephedrin content as follows (bases): - Divided dose: ≤ 120 mg/unit - Undivided dose: ≤ 0.5% | Not more than 15 days’ dose of products that contain Pseudoephedrine may be sold without prescription. Retailers must record buyers’ names and addresses. |
216 | Pseudoephedrine HCl combined with other ingredients in cough medicines, antipyretic drugs, pain relievers, anti-allergy medication | Oral administration: various form with limited Pseudoephedrin content as follows (bases): - Divided dose: ≤ 120 mg/unit - Undivided dose: ≤ 0.5% | Not more than 15 days’ dose of products that contain Pseudoephedrine may be sold without prescription. Retailers must record buyers’ names and addresses. |
217 | Pyrantel | Oral administration: various form | Vermifuge |
218 | Ranitidine | Oral administration: various form, divided dose ≤ 75 mg | Not more than 15 days’ dose shall be sold without prescription |
219 | Rutin as a single substance or combined with Vitamin C and/or herbal extracts | Oral administration: various form |
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220 | Saccharomyces boulardic | Oral administration: various form |
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221 | Saccharomyces cerevisiae combine with Trihydrate Magnesium Sulfat | Oral administration: various form |
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222 | Iron compounds as a single substance or combined with vitamins or minerals | Oral administration: various form | Supplementation of iron |
223 | Organic selenium combined with vitamins or minerals | Oral administration: various form with the following limits: - Divided dose: ≤ 50 mcg/unit |
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224 | Selenium sulfide | Topical administration |
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225 | Silymarin as a single substance or combined with Vitamins and/or herbal ingredients | Oral administration: various form |
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226 | Simethicon as a single substance or combined with Pancreatin and/or Acid Desoxycholic and/or B vitamins and/or enzymes | Oral administration: various form |
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227 | Simethicon combined with aluminum compounds, magnesium, and/or Dicyclomine and/or activated carbon | Oral administration: various form |
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228 | Sorbitol as a single substance or combined with other ingredients | Oral administration: various form |
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229 | Sterculia (gum sterculia) | Oral administration: various form Enema |
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230 | Sucralfate | Oral administration: various form |
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231 | Sulbutiamine | Oral administration: various form |
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232 | Sulfogaiacol as a single substance or combined with other ingredients in cough medicines, antipyretic drugs, pain relievers | Oral administration: various form |
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233 | Terbinafine | Topical administration: various forms with concentration ≤ 5% |
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234 | Terpin as a single substance or combined with Codeine | Oral administration: various form Combined codeine (bases) with following concentration limits on: - Divided dose: ≤ 12 mg/unit - Undivided dose: ≤ 2.5% | Not more than 10 days’ dose of products that contain Codein may be sold without prescription. Retailers must record buyers’ names and addresses. |
235 | Tetrahydrozoline | Nasal administration |
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236 | Activated carbon as a single substance or combined with Simethicone | Oral administration: various form |
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237 | Essential oil (including Menthol, Pinen, Camphor, Cineol, Fenchone, Borneol, Anethol, Eucalyptol, etc.) | Oral administration: various form Topical administration: applied to the skin Mouthwash, oral mucosa cream |
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238 | Tioconazole as a single substance or combined with Hydrocortisone | Topical administration: various forms with the following concentration: - Tioconazole ≤ 1.00% - Hydrocortisone ≤ 0.05% |
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239 | Tolnaftate | Topical administration |
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240 | Triclosan as a single substance or combined with other ingredients in topical products | Topical administration |
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241 | Triprolidine as a single substance or combined with other ingredients in cough medicines, antipyretic drugs, pain relievers
| Oral administration: various form | Products that contain Pseudoephedrin must comply with regulations applied to drugs that contain Pseudoephedrin (No. 216 of this List) |
242 | Trolamine as a single substance or combined with Triclosan and/or Tyrothricin in topical products | Topical administration |
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243 | Tyrothricin as a single substance or combined with Benzalkonium, Benzocaine, Formaldehyde, Trolamine, essential oil, ingredients in essential oil | Oral administration: lozenges Topical administration: skin cream, mouth spray, mouthwash, |
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244 | Urea as a single substance or combined with Vitamin E and/or Bifonazole and/or herbal ingredients that are not mentioned on the list of toxic herbal ingredients | Topical administration |
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245 | Vitamin A and provitamin A (Betacarotene) as a single substance or combined with vitamins | Oral administration: various forms with vitamin A content ≤ 5000 IU/unit Topical administration Intravitreal administration |
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246 | Vitamin as a single substance (except Vitamin D) or combines with other Vitamins, minerals, amino acids, fatty acids, Taurine, Lutein, Zeaxanthin | Oral administration: various form Topical administration Oral administration: various form with the following Vitamin A content limit: Vitamin A ≤ 5000 IU/divided dose | Supplementation of vitamins, minerals, and nutrients |
247 | B vitamins, vitamin PP as a single substance or combined with other ingredients | Intravitreal administration
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248 | Bacteria beneficial to the gastrointestinal tract: Bacillus claussi, Bacillus subtilis, Lactobacillus acidophilus including those combined with vitamins | Oral administration: various form |
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249 | Methylene blue | Topical administration |
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250 | Xylometazoline as a single substance or combined with Benzalkonium. | Nasal administration with Xylometazoline content ≤ 1% |
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2. ORIENTAL MEDICINES AND HERBAL MEDICINES
Oriental medicines and herbal medicines that do not contain the herbal ingredients on the list of toxic herbal ingredients (promulgated together with the Circular No. 33/2012/TT-BYT dated December 28, 2012 of the Minister of Health), herbal ingredients that have known or warned serious harmful effects are classified as OTC drugs.
Oriental medicines and herbal medicines that contain the herbal ingredients on the list of toxic herbal ingredients (promulgated together with the Circular No. 33/2012/TT-BYT dated December 28, 2012 of the Minister of Health), herbal ingredients that have known or warned serious harmful effects shall be classified as OTC drugs or prescription drugs according to their formulae, indications, and known undesirable effects.
| MINISTER |
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