Thông tư 23/2014/TT-BYT

Circular No. 23/2014/TT-BYT dated June 30, 2014, promulgation of list of otc drugs

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
Independence - Freedom - Happiness
---------------

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




Nguyen Thi Kim Tien

 

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%

 

209

Policresulen (Metacresolsulphonic acid-formaldehyde)

Topical administration

Rectal suppositories

 

210

Polyethylen glycol 400 as a single substance or combined with Propylene glycol

Intravitreal administration

 

211

Polysacharide

Oral administration: various form

 

212

Polytar as a single substance or combined with other ingredients in topical products (Zinc Pyrithion, etc.)

Topical administration

 

 

213

Povidone Iodine

Topical administration: various forms (including ≤ 1% mouthwash) Intravitreal administration

 

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%

 

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

 

220

Saccharomyces boulardic

Oral administration: various form

 

221

Saccharomyces cerevisiae combine with Trihydrate Magnesium Sulfat

Oral administration: various form

 

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

 

224

Selenium sulfide

Topical administration

 

225

Silymarin as a single substance or combined with Vitamins and/or herbal ingredients

Oral administration: various form

 

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

 

227

Simethicon combined with aluminum compounds, magnesium, and/or Dicyclomine and/or activated carbon

Oral administration: various form

 

228

Sorbitol as a single substance or combined with other ingredients

Oral administration: various form

 

229

Sterculia (gum sterculia)

Oral administration: various form

Enema

 

230

Sucralfate

Oral administration: various form

 

231

Sulbutiamine

Oral administration: various form

 

232

Sulfogaiacol as a single substance or combined with other ingredients in cough medicines, antipyretic drugs, pain relievers

Oral administration: various form

 

233

Terbinafine

Topical administration: various forms with concentration ≤ 5%

 

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

 

236

Activated carbon as a single substance or combined with Simethicone

Oral administration: various form

 

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

 

238

Tioconazole as a single substance or combined with Hydrocortisone

Topical administration: various forms with the following concentration:

- Tioconazole ≤ 1.00%

- Hydrocortisone ≤ 0.05%

 

239

Tolnaftate

Topical administration

 

240

Triclosan as a single substance or combined with other ingredients in topical products

Topical administration

 

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

 

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,

 

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

 

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

 

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

 

 

248

Bacteria beneficial to the gastrointestinal tract: Bacillus claussi, Bacillus subtilis, Lactobacillus acidophilus including those combined with vitamins

Oral administration: various form

 

249

Methylene blue

Topical administration

 

250

Xylometazoline as a single substance or combined with Benzalkonium.

Nasal administration with Xylometazoline content ≤ 1%

 

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




Nguyen Thi Kim Tien

 

 


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Thuộc tính Văn bản pháp luật 23/2014/TT-BYT

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Số hiệu23/2014/TT-BYT
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Ngày ban hành30/06/2014
Ngày hiệu lực15/08/2014
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