Thông tư 07/2017/TT-BYT

Circular No. 07/2017/TT-BYT dated May 03, 2017, promulgation of List of OTC drugs

Nội dung toàn văn Circular 07/2017/TT-BYT promulgation of List of OTC drugs


MINISTRY OF HEALTH
---------

SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
---------------------

No.: 07/2017/TT-BYT

Hanoi, May 03, 2017

 

CIRCULAR

PROMULGATION OF LIST OF OTC DRUGS

Pursuant to the Pharmaceutical Law dated April 06, 2016;

Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 defining Functions, Tasks, Powers and Organizational Structure of Ministry of Health;

At the request of Director of Drug Administration of Vietnam, Minister of Health promulgates the “Circular on promulgation of list of OTC drugs”.

Article 1. Scope

This Circular provides for rules for compiling the list of OTC drugs, criteria for selection of OTC drugs; List of OTC drugs; purposes and implementation thereof.

Article 2. Rules for compiling List of OTC drugs and criteria for selection of OTC drugs

1. Rules for compiling List of OTC drugs

a) Ensure safety for drug users;

b) Ensure people’s timely access to OTC drugs;

c) Conform to the reality of use and supply of drugs in Vietnam;

d) Be harmonized with rules and regulations on classification of OTC drugs announced by the States in the region and the world.

2. Criteria for selection of OTC drugs

Drugs that satisfy all criteria below shall be put on the List of OTC drugs:

a) Any drug with low toxicity, does not create toxic degradation products, does not have serious adverse reactions that are known or warned against by the World Health Organization, regulatory authorities of Vietnam or foreign countries, and may cause any of the following adverse effects:

- Cause death;

- Threaten life;

- Need hospitalization or prolonged treatment;

- Cause permanent or serious impairments;

- Cause congenital malformations;

- Cause other drug adverse reactions that may cause adverse clinical effects on patients as assessed and judged by medical practitioners.

b) 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;

c) Drugs indicated to treat common diseases which can be treated by patients themselves without prescription and monitoring from medical practitioners;

d) Drugs of which the administration routes and dosage forms are simple (oral, topical administration), and the concentration are appropriate for self-treatment by patients;

dd) Drugs that rarely interact with other drugs or common foods and drinks;

e) Drugs that do not cause dependence;

g) Drugs that do not pose risks of overdose or misuse affecting the safety of drug users;

h) Drugs that have been selling in Vietnam for at least 05 years.

Article 3. List of OTC drugs

The List of OTC drugs is stated in the Appendix enclosed herewith.

Article 4. Purposes of List of OTC drugs

1. The List of OTC drugs is the basis for separating OTC drugs and prescription drugs. Drugs that are not listed on the List of OTC drugs must be classified as prescription drugs.

2. The List of OTC drugs is the basis for formulation and promulgation of regulations and instructions by regulatory authorities on registration, manufacture, export, import, distribution, advertising of OTC drugs, inspection and handling of violations and other relevant activities.

Article 5. Effect

1. This Circular takes effect as from July 01, 2017.

2. The Circular No. 23/2014/TT-BYT dated June 30, 2014 by Minister of Health on promulgation of List of OTC drugs shall be null and void as from the date of entry into force of this Circular.

Article 6. Transition provision

1. Drugs on the List of OTC drugs promulgated under this Circular shall be provided, retailed and used without prescription as from the entry into force of this Circular, unless they are classified as prescription drugs as written on drug labels (and package inserts) which must be provided, retailed and used according to prescriptions.

2. With regard to drugs that have registration numbers in Vietnam or import permits before this Circular takes effect:

a) With regard to drugs that are on the List of OTC drugs promulgated under the Circular No. 23/2014/TT-BYT but not on the List of OTC drugs enclosed herewith, holders of certificate of free sales and drug importers must classify, update and provide additional information concerning drug classifications in accordance with regulations herein on drug labels and package inserts according to the roadmap prescribed in Minister of Health’s Circulars on labeling of drugs and medicinal ingredients before such drugs are sold on the market.

b) With regard to drugs that are not on the List of OTC drugs promulgated under the Circular No. 23/2014/TT-BYT but on the List of OTC drugs enclosed herewith, since the entry into force of this Circular, holders of certificate of free sales and drug importers are encouraged to classify, update and provide additional information concerning drug classifications in accordance with regulations herein on drug labels and package inserts before selling drugs on the market; or drugs with approved drug classifications on labels and package inserts may be manufactured, imported and sold on the market until their expiry dates.

3. With regard to applications for drug registration in Vietnam and applications for permit to import drugs without certificate of free sale in Vietnam that are submitted to the Drug Administration of Vietnam before the date of entry into force of this Circular and are not yet processed:

a) With regard to drugs that are on the List of OTC drugs promulgated under the Circular No. 23/2014/TT-BYT but not on the List of OTC drugs enclosed herewith, applicants must carry out drug classifications under regulations herein;

b) With regard to drugs that are not on the List of OTC drugs promulgated under the Circular No. 23/2014/TT-BYT but on the List of OTC drugs enclosed herewith, applicants may carry out drug classifications according to submitted applications or in accordance with regulations herein.

Article 7. Implementation responsibility

1. Responsibility of pharmacy establishments and health facilities:

a) Implement regulations herein;

b) Propose revision to the List of OTC drugs in conformity with the reality to ensure the timely provision of drugs serving the prevention and treatment of diseases.

2. Responsibility of the Drug Administration of Vietnam:

a) Take charge of and cooperate with regulatory bodies in implementing this Circular;

b) Review the List of OTC drugs, except non-prescription traditional medicines, and submit reports thereof to the Minister of Health according to proposals and suggestions of units mentioned in Clause 1 herein or conclusion of the Advisory Council for issuance of certificate of free sale of drugs and medicinal ingredients.

3. Responsibility of the Traditional Medicine Administration of Vietnam:

a) Cooperate with the Drug Administration of Vietnam and regulatory bodies in implementing this Circular;

b) Review the List of non-prescription traditional medicines and submit reports thereof to the Minister of Health according to proposals and suggestions of units mentioned in Clause 1 herein or conclusion of the Advisory Council for issuance of certificate of free sale of drugs and medicinal ingredients.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Drug Administration of Vietnam or the Traditional Medicine Administration of Vietnam (if related to traditional medicines) for consideration./.

 

 

PP MINISTER
DEPUTY MINISTER




Truong Quoc Cuong

 

LIST

OF OTC DRUGS
(Enclosed with the Circular No. 07/2017/TT-BYT dated May 03, 2017 by Minister of Health)

I. LIST OF OTC MODERN DRUGS AND BIOLOGICALS

No.

Active ingredients

Administration route, dosage form and concentration limit

Other regulations

1

Acetylcystein

Oral administration: various forms

 

2

Acetylleucin

Oral administration: various forms

 

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 forms

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 forms

 

5

Amino acid as a single substance or combined with other substances (including combinations with vitamins)

Oral administration: various forms

Indications: supplementation of amino acids and vitamins

6

Aminobenzoic acid (para aminobenzoic acid)

Oral administration: various forms

 

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 forms

 

10

Acid cromoglicic and various forms of cromoglicat salts

Intravitreal administration, nasal administration with ≤ 2% of cromoglicic acid

 

11

Dimecrotic acid

Oral administration: various forms

 

12

Folic acid as a single substance or combined with iron and/or B Vitamins, minerals, sorbitol

Oral administration: various forms

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 forms

 

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

Albendazol

Oral administration: various forms

Indication: 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 forms

 

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 forms

 

25

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

Oral administration: various forms 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 forms

 

27

Amylmetacresol combined with essential oil, Bacitracin, etc. in lozenges

Oral administration: lozenges

 

28

Argyron

Intravitreal administration

Topical administration

 

29

Aspartam

Oral administration: various forms

 

30

Aspartat as a single substance or combined with other substances

Oral administration: various forms

 

31

Attapulgit

Oral administration: various forms

 

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 dipropionat

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 forms

Transdermal patch

 

42

Berberin

Oral administration: various forms

 

43

Biclotymol as a single substance or combined with Enoxolon and/or Phenylephrin HCl and/or Clorpheniramin maleat and/or essential oil

Topical administration

Nsal 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 forms

Indication: treatment of heartburn

47

Boldine

Oral administration: various forms

 

48

Bromhexine Hydrochloride as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers

Oral administration: various forms  with limited Bromhexin Hydrochloride content:

- Divided dose: ≤ 8mg/unit;

- Undivided dose: ≤ 0,8%

Rectal suppositories

 

49

Bromelain as a single substance or combined with Trypsin

Oral administration: various forms

 

50

Brompheniramin maleat as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers

Oral administration: various forms

 

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 forms

 

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 forms

Indications: supplementation of calcium

57

Carbinoxamine as a single substance or combined with Pseudoephedrin Hydrochloride and/or Bromhexin and/or Paracetamol in cough medicines, antipyretic drugs, pain relievers

Oral administration

Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses

58

Carbocystein

Oral administration: various forms

 

59

Carbomer

Topical administration

Intravitreal administration

 

60

Catalase as a single substance or combined with Neomycin in topical products

Topical administration

 

61

Cetirizin dihydrochlorid

Oral administration: various forms

 

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 forms

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 forms

 

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 withlimited concentration of Cimetidin ≤ 200 mg/unit

Indication: treatment of heartburn

70

Cinarizin

Oral administration: various forms

 

71

Cinchocain combined with Hydrocortison, Neomycin, Esculin, etc. in topical products, rectal suppositories

Topical administration

Rectal suppositories

 

72

Citrullin

Oral administration: various forms

 

73

Clobetason butyrat

Topical administration

 

74

Clorhexidin

Topical administration

 

75

Clorophyl

Oral administration: various forms

 

76

Chlorpheniramine maleate as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers

Oral administration: various forms

Divided dose in form of single substance: Chlorpheniramine maleate ≤ 4 mg/unit.

 

77

Chlorpheniramine maleate combined with Chondroitin and/or Vitamins

Intravitreal administration

 

78

Clotrimazol

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 forms with the following limits on Codeine concentration (bases):

- Divided dose: ≤ 12mg/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

80

Coenzym Q10 as a single substance or combined with Vitamins

Oral administration: various forms

 

81

Crotamiton

Topical administration

 

82

Dequalinium as a single substance or combined with Tyrothricin, Hydrocortison, Glycyrrhetinic Acid, Lidocain, etc. in topical products, lozenges

Topical administration

Vaginal suppositories

Oral administration: lozenges

 

83

Desloratadin

Oral administration: verious forms, concentration ≤ 5 mg/divided dose

Or oral administration with maximum dose of 5mg per day

 

84

Dexbrompheniramin maleat as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers

Oral administration: various forms

 

85

Dexclorpheniramin maleat as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers

Oral administration: various forms

 

86

Dexpanthenol

Intravitreal administration

Topical administration

 

87

Diclofenac as a single substance or combined with Methyl salicylat, substances of essential oil group, etc.

Topical administration

Intravitreal administration (single form)

 

88

Dicyclomin

Oral administration: various forms

 

89

Diethylphtalat (DEP)

Topical administration

 

90

Dimenhydrinat

Oral administration: various forms

 

91

Dimethicon (Dimethylpolysiloxan) as a single substance or combined with Guaiazulen

Oral administration: various forms

 

92

Dimethicon combined with Zinc, Calamin, Cetrimid, etc. in topical products

Topical administration

 

93

Dimethinden

Oral administration: various forms

Topical administration

 

94

Dinatri Inosin monophosphat

Intravitreal administration

 

95

Diosmectit (Dioctahedral smectit)

Oral administration: various forms

 

96

Diosmin combined with Hesperidin and/or some herbal ingredients that contain Flavonoid

Oral administration: various forms

 

97

Diphenhydramin hydroclorid or monocitrate

Oral administration: various forms with the following concentration limits (bases):

- Divided dose: ≤ 50mg/unit;

- Undivided dose: ≤ 2.5%

 

98

Sulfate copper

Topical administration

 

99

Doxylamin combined with Paracetamol, Pseudoephedrin Hydrochloride, and other active ingredients on OTC drug list in cough medicines, antipyretic drugs, pain relievers

Oral administration: various forms

Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses

100

Econazol as a single substance or combined with Hydrocortison

Topical administration: with Hydrocortison concentration (bases) ≤ 0.05%

 

101

Enoxolon as a single substance or combined with other substances in topical products, lozenges

Topical administration: skin cream, oral mucosa cream, mouthwash

Oral administration: lozenges

 

102

Ephedrin Hydrochlorid

Intravitreal administration, nasal administration: ≤ 1% solution or ≤ 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

103

Eprazinon

Oral administration: various forms

 

104

Esdepallethrin combined with Piperonyl, essential oil, or ingredients of essential oil in topical products

Topical administration

 

105

Estradiol as a single substance or combined with Dydrogesteron

Oral administration: various forms, divided dose

* Indication: contraception

106

Ethanol as a single substance or combined with other substances

Topical administration (antiseptic alcohol)

Oral administration: combined with other ingredients

 

107

Ethylestradiol as a single substance

Oral administration: various forms, divided dose

* Indication: contraception

108

Etofenamat

Topical administration

 

109

Famotidin

Oral administration: divided dose with concentration ≤20mg/unit

Not more than 14 days’ dose of drugs may be sold without prescription

110

Fenticonazol

Topical administration

 

111

Fexofenadin

Oral administration: various forms

 

112

Flurbiprofen

Lozenges 

Topical administration

Intravitreal administration

 

113

Glucosamin as a single substance or combined with Chondroitin and/or Vitamins

Oral administration: various forms

 

114

Glucose or Dextrose as a single substance or combined with sodium or potassium

Oral administration: various forms

Indications: supplementation of sugar or electrolyte

115

Glycerin as a single substance or combined with Polysorbat 80 in topical products or eye drops

Topical administration

Intravitreal administration

 

116

Glycerol combined with herbal extracts

Enema

 

117

Guaiphenesin as a single substance or combined with other ingredients on OTC drug list in cough medicines, antipyretic drugs, pain relievers

Oral administration: various forms

Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses

118

Hexamidin as a single substance or combined with Cetrimid, Lidocain, Clotrimazol or Catalase

Topical administration

 

119

Hexetidin as a single substance or combined with Benzydamin, Cetylpyridinum, Cholin Salicylat, Methyl salicylat, essential oil, etc.

Topical administration: skin cream, mouthwash

 

120

Hydrocortison as a single substance or combined with Miconazol, Econazol, Tioconazol, Neomycin

Topical administration: various forms with concentration of Hydrocortison ≤ 0.5%

 

121

Hydrogen Peroxid as a single substance or combined with Sodium Lauryl sulfat and/or essential oil, etc.

Topical administration

 

122

Hydrotalcit

Oral administration: various forms

 

123

Hyoscine (Scopolamin) butylbromid as a single substance or combined with Meclizin hydrochlorid

Oral administration: various forms, including chewable tablets  

Concentration ≤ 20mg/ divided dose

Transdermal patch

 

124

Hydroxypropyl methylcellulose (Hypromellose, HPMC) as a single substance or combined with Dextran 70 and/or Carbomer

Intravitreal administration: various forms

 

125

Ibuprofen

Oral administration: verious forms with concentration ≤ 400 mg/divided dose.

Topical administration

 

126

Ichthammol

Topical administration

 

127

Indomethacin

Topical administration

0.1% eye drops

 

128

Iodine combined with Potassium Iodide and/or Benzoic Acid and/or Salicylic Acid

Topical administration: Iodine concentration ≤ 5%

 

129

Isoconazol

Topical administration

 

130

Isopropyl Methylphenol

Topical administration

 

131

Zinc oxid, zinc pyrithione, zinc gluconate, zinc undecylenate as a single substance or combined with other ingredients in topical products

Topical administration

 

132

Sulfate zinc

Topical administration

Intravitreal administration

 

133

Ketoconazol as a single substance or combined with Pirythion Zinc and/or Hydrocortison and/or Trolamin

Topical administration: various forms with concentration of Ketoconazol ≤ 2%

 

134

Ketoprofen

Topical administration

 

135

Lactitol

Oral administration: various forms

 

136

Lactoserum atomisate

Topical administration

 

137

Lactulose

Oral administration: various forms

 

138

L-Carnitin as a single substance or combined with Vitamins

Oral administration: various forms

 

139

Levocetirizin

Oral administration: various forms

 

140

Levonorgestrel as a single substance or combined with Ethylestradiol

Oral administration: various forms

* Indication: contraception

141

Lidocain as a single substance or combined with other substances

Topical administration

 

142

Lindan(Benhexachlor, 666, Gamma-BHC) as a single substance or combined with Lidocain

Topical administration: Lindan concentration ≤ 1%

 

143

Loperamid

Oral administration: verious forms with Loperamid concentration ≤ 2mg/divided dose

 

144

Loratadin as a single substance or combined with Pseudoephedrin Hydrochlorid and/or Paracetamol

Oral administration: various forms with the following concentration limits (bases):

- Divided dose: Loratadin ≤ 10mg/unit;

- Undivided dose: Loratadin ≤ 0.1%

Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses

145

Loxoprofen

Oral administration: various forms

 

146

Macrogol

Oral administration: various forms

Enema

 

147

Magaldrat as a single substance or combined with compounds of aluminum, magnesium, Alginic Acid (or Alginat salt).

Oral administration: various forms

 

148

Magnesi including salts or compounds of magnesium

Oral administration: various forms

Indications: supplementation of magnesium, gastric acid neutralization, laxatives.

149

Mangiferin

Topical administration

 

150

Mebendazol

Oral administration: various forms with the following concentration limits:

- Divided dose: ≤ 500mg/unit

- Undivided dose: ≤ 2%

 

151

Mebeverin

Oral administration: divided dose: ≤ 200mg/unit

 

152

Cellulase fongique

Oral administration: various forms

 

153

Enzymes as a single substance or combined with other substances (including combinations with vitamins)

Oral administration: various forms

 

154

Menthol combined with other active ingredients such as mixtures of essential oil, Methyl Salycilate, etc.

Oral administration: various forms

Topical administration: various forms

 

155

Mequinol

Topical administration

 

156

Mequitazin

Oral administration: various forms

Topical administration

 

157

Mercurocrom

Topical administration: ≤ 30ml per pack

Not more than 2 packs may be sold without prescription

158

Methyl salicylat combined with essential oil, etc. in lozenges, topical products

Topical administration

Transdermal patch

Lozenges 

 

159

Metronidazol

Topical administration

 

160

Miconazol

Topical administration

Vaginal cream ≤ 2%

 

161

Miconazole combined with Hydrocortison

Topical administration

Vaginal cream Miconazol ≤2%; Hydrocortison ≤0.05%

 

162

Minoxidil

Topical administration: various forms with concentration ≤ 5%

 

163

Mometasone

Nasal administration: ≤ 50 mcg/dose, ≤ 200 doses per box;

Topical administration.

 

164

Mupirocin

Topical administration

 

165

Myrtol as a single substance or combined with other substances in lozenges

Oral administration: various forms

Topical administration

 

166

Naphazolin as a single substance or combined with Diphenylhydramin and/or Procain in nasally administered drugs

Nasal administration with Naphazolin concentration ≤ 0.05%

 

167

Naphazolin combined with Pheniramin; Vitamin glycyrhizinat, Dexpanthenol, etc. in eye drops

Intravitreal administration: various forms with Naphazolin concentration ≤ 0.1%

 

168

Naproxen

Oral administration: verious forms with concentration ≤ 275mg/divided  dose

 

169

Sodium benzoate as a single substance or combined with other substances

Oral administration: various forms

 

170

Sodium bicacbonate as a single substance or combined with other substances

Oral administration: various forms

 

171

Sodium carbonate as a single substance or combined with other substances

Oral administration: various forms

 

172

Sodium Carboxymethylcellulose (Na CMC)

Intravitreal administration

 

173

Sodium Chloride as a single substance or combined with Potassium Citrate, Sodium citrate, etc.

Oral administration: various forms

Topical administration

Intravitreal administration, nasal administration with concentration ≤ 0.9%

 

174

Sodium Docusat

Oral administration: various forms

 

175

Sodium Fluoride combined with other ingredients

Topical administration: toothpaste, mouthwash

 

176

Sodium Hyaluronat (Hyaluronic acid)

Topical administration

Eye drops with concentration ≤ 0.1%

 

177

Sodium Monofluorophosphate

Topical administration, including products for cleaning the oral cavity, mucous membrane

 

178

Sodium Salicylate combined with other ingredients

Oral administration: combined with other ingredients in lozenges

Topical administration

 

179

Neomycin sulfate combined with other ingredients in lozenges (Zinc; Bacitracin; Amylocaine, etc.), topical products

Oral administration: lozenges

Topical administration

 

180

Trace elements: chrome, copper, potassium, magnesium, manganese, zinc, etc. as a single substance or combined with other ingredients, including vitamins

Oral administration: various forms

Indications: supplementation of minerals

181

Aluminum, magnesium, calcium, and compounds thereof as a single substance or combined with other ingredients

Oral administration: various forms

Indications: gastric acid neutralization, treatment for gastric and duodenal ulcer

182

Nonahydrated Natri Sulfid + Saccharomyces Cerevisiae

Oral administration: various forms

Topical administration

 

183

Noscarpin

Oral administration: various forms

 

184

Nystatin as a single substance or combined with other substances

Topical administration

 

185

Omeprazol

Oral administration: concentration ≤ 10 mg/divided dose

Indication: treatment of heartburn  Not more than 14 days’ dose of drugs shall be sold only one time without prescription and maximum dose of ≤ 20mg per day

186

Orlistat

Oral administration: various forms

 

187

Ossein hydroxyapatite

Oral administration: various forms

 

188

Oxeladine

Oral administration: various forms

 

189

Oxomemazine

Oral administration: various forms

 

190

Oxymetazoline

Nasal administration with concentration ≤ 0.5%

 

191

Pancreatin as a single substance or combined with Simethicon and/or enzymes and/or B vitamins and/or Azintamid

Oral administration: various forms

.

192

Panthenol

Topical administration

Intravitreal administration

 

193

Paracetamol as a single substance

Oral administration: various forms

Rectal suppositories

Combinations of paracetamol with other substances are specified in the list

194

Paracetamol combined with active ingredients in this List, meant to treat cough, reduce fever, relief pain, prevent allergy

Oral administration: various forms

Combinations that contain active ingredients that have limited concentrations and may be retailed only once must comply with corresponding regulations applied thereto

195

Pentoxyverin

Oral administration: various forms

 

196

Phenylephrine Hydrochloride

Intravitreal administration, nasal administration with concentration ≤ 1%

 

197

Phenylephrine Hydrochloride combined with other ingredients in topical products (such as Petrolatum sperti yellow; Mineral oil light; Shark liver oil, etc.)

Topical administration

 

198

Phenylephrine Hydrochloride combined with other ingredients in cough medicines, antipyretic drugs, pain relievers

Oral administration: various forms

Rectal suppositories

 

199

Phospholipid

Oral administration: various forms

 

200

Picloxydin

Intravitreal administration

 

201

Piroxicam

Topical administration: various forms with concentration ≤ 1%

 

202

Policresulen (Metacresolsulphonic acid-formaldehyd)

Topical administration

Rectal suppositories

 

203

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

Intravitreal administration

.

204

Polysacharid

Oral administration: various forms

 

205

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

Topical administration

 

206

Povidon Iodin

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

 

207

Promethazin Hydrochloride as a single substance or combined with Carbocystein, Paracetamol, etc. in cough medicines, antipyretic drugs, pain relievers

Oral administration: various forms with the following Promethazin concentration limits (bases):

- Divided dose: ≤ 12.5mg/unit;

- Undivided dose: ≤ 0.1%

Topical administration: concentration ≤ 2%

 

208

Pseudoephedrin Hydrochloride combined Cetirizine

Oral administration: various forms with the following Pseudoephedrin concentration limits (bases):

- Divided dose: ≤ 120mg/unit;

- Undivided dose: ≤ 0.5%

Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription

Retailers must record buyers’ names and addresses

209

Phenylephrine Hydrochloride combined with other ingredients in cough medicines, antipyretic drugs, pain relievers and anti-allergy medication

Oral administration: various forms with the following Pseudoephedrin concentration limits (bases):

- Divided dose: ≤ 120mg/unit;

- Undivided dose: ≤ 0.5%

Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses

210

Pyrantel

Oral administration: various forms

Indication: vermifuge

211

Ranitidin

Oral administration: various forms, with concentration ≤ 75mg/divided dose

Not more than 15 days’ dose of drugs may be sold without prescription.

Indication: treatment of hearburn

212

Rutin as a single substance or combined with Vitamin C and/or herbal extracts

Oral administration: various forms

 

213

Saccharomyces boulardic

Oral administration: various forms

 

214

Saccharomyces cerevisiae combined with Trihydrat Magnesi Sulfat

Oral administration: various forms

 

215

Iron compounds as a single substance or combined with vitamins or minerals

Oral administration: various forms

Indications: supplementation of iron.

216

Organic selenium combined with vitamins or minerals

Oral administration: various forms with the following concentration limits:

- Divided dose of selenium: ≤ 50mcg/unit

 

217

Selenium sulfide

Topical administration

 

218

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

Oral administration: various forms

 

219

Simethicon as a single substance or combined with Pancreatin and/or Desoxycholic Acid and/or B vitamins and/or enzymes

Oral administration: various forms

 

220

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

Oral administration: various forms

 

221

Sorbitol as a single substance or combined with other substances

Oral administration: various forms

 

222

Sterculia (gum sterculia)

Oral administration: various forms

Enema

 

223

Sucralfate

Oral administration: various forms

 

224

Sulbutiamine

Oral administration: various forms

 

225

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

Oral administration: various forms

 

226

Terbinafine

Topical administration: various forms with concentration ≤ 1%

 

227

Terpin as a single substance or combined with Codeine

Oral administration: various forms

Combined Codein with the following concentration limits (bases):

- Divided dose: ≤ 12mg/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

228

Tetrahydrozoline

Nsal administration

 

229

Activated carbon as a single substance or combined with Simethicone

Oral administration: various forms

 

230

Essential oil (including Menthol, Pinen, Camphor, Cineol, Fenchone, Borneol, Anethol, Eucalyptol, etc.)

Oral administration: various forms

Topical administration: skin cream

Mouthwash, oral mucosa cream

 

231

Tioconazol as a single substance or combined with Hydrocortison

Topical administration: various forms with the following concentration limits:

- Tioconazol ≤ 1.00%

- Hydrocortison ≤ 0.05%

 

232

Tolnaftate

Topical administration

 

233

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

Topical administration

 

234

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

Oral administration: various forms

Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses

235

Trolamin as a single substance or combined with other ingredients (with Triclosan and/or Tyrothricin) in topical products

Topical administration

 

236

Tyrothricin as a single substance or combined with Benzalkonium, Benzocain, Formaldehyd, Trolamin, essential oil, ingredients in essential oil

Oral administration: lozenges

Topical administration: mouthwash, mouth spray, skin cream

 

237

Urea as a single substance or combined with Vitamin E and/or Bifonazol and/or herbal ingredients that are not mentioned on the list of toxic herbal ingredients

Topical administration

 

238

Vitamin A and provitamin A (Betacarotene) as a single substance or combined with vitamins

Oral administration: various forms with Vitamin A concentration ≤ 5000 IU/unit

Topical administration

Intravitreal administration

 

239

Vitamin as a single substance (except Vitamin D) or combined with other Vitamins, minerals, amino acids, fatty acids, Taurine, Lutein, Zeaxanthin

Oral administration: various forms

Topical administration

Oral administration: various forms with the following Vitamin A concentration limits:

Vitamin A 5000 IU/divided unit

Indication: supplementation of vitamins, minerals and nutrients

240

B vitamins, vitamin PP as a single substance or combined with other ingredients

Intravitreal administration

 

241

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

Oral administration: various forms

 

242

Methylene blue

Topical administration

 

243

Xylometazolin as a single substance or combined with Benzalkonium.

Nsal administration with Xylometazolin concentration ≤ 1%

 

* With regard to contraception drugs on this List, drug retailers who are bachelors of pharmacy or persons in charge of pharmacy expertise of drug retailers are responsible for providing and giving instructions about drug-related information, including: the drug name, effects, indications, contraindications, dosage, route of administration, and notes for using drugs before providing or selling drugs to buyers.

II. OTC HERBAL DRUGS, TRADITIONAL DRUGS (EXCEPT TRADITIONAL INGREDIENTS)

Herbal drugs, traditional drugs (except traditional ingredients) which meet all of the following criteria shall be classified as OTC drugs:

1. Do not contain herbal ingredients on the List of toxic herbal ingredients announced by Minister of Health.

2. Do not have any of the following indications:

a) Use as supportive drugs or for treatment of cancer or tumour;

b) Treatment of cardiovascular diseases or blood pressure diseases;

c) Treatment of liver, biliary or pancreas diseases (excluding liver tonics);

d) Treatment of Parkinson disease;

dd) Treatment of viral infection;

e) Treatment of fungal infections (excluding topical antifungal medications);

g) Treatment of tuberculosis;

h) Treatment of malaria;

i) Treatment of gout;

k) Treatment of asthma;

l) Treatment of endocrine diseases;

m) Treatment of blood disorders or diseases;

n) Treatment of blood disorders or diseases;

o) Treatment of kidney and genitourinary system diseases (excluding kidney yang tonics);

p) Treatment of bacterial contamination diseases (excluding topical antibiotics);

q) Treatment of chronic insomnia;

r) Treatment of psychological disorders and mental illness;

s) Drug abuse treatment or supportive drugs for addiction treatment (including supportive drugs for detoxification);

t) Interruption of pregnancy;

u) Treatment of dangerous and emerging infectious diseases as regulated by Minister of Health.

III. OTC TRADITIONAL INGREDIENTS

Traditional ingredients that are not manufactured or made of herbal ingredients on the List of toxic herbal ingredients announced by Minister of Health shall be classified as OTC (non-prescription) drugs.


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