Circular No. 08/2009/TT-BYT dated July 01, 2009 of the Ministry of Health on the List of over-the-counter (OTC) drugs

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Circular No. 08/2009/TT-BYT dated July 01, 2009 of the Ministry of Health on the List of over-the-counter (OTC) drugs
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Official number:08/2009/TT-BYTSigner:Cao Minh Quang
Type:CircularExpiry date:
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Issuing date:01/07/2009Effect status:
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THE MINISTRY OF HEALTH
--------

No. : 08/2009/TT-BYT

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

Hanoi, July 01, 2009

 

CIRCULAR

LIST OF OVER-THE-COUNTER (OTC) DRUGS

Pursuant to Decree No. 188/2007/ND-CP dated December 27, 2007 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to Pharmacy Law No. No. 34/2005/QH11 dated June 14, 2005;

To ensure the safety for the drug users and create favorable conditions for the patients to buy drug to treat minor illnesses and common symptoms by themselves. The Ministry of Health issues and guides the implementation the "List of OTC drugs" as follows:

Article 1. Issuing together with this Circular the "List of OTC drugs", including:

1. List of pharmaceutical drugs;

2. List of drugs originated from medicinal herbs.

Article 2. Explanation of terms

1.OTC drugsare the drug dispensed, sold and used without prescription;

2.Prescription drugsare the drugs if not used in accordance with the prescriber’s indication, they may be dangerous to life or health; it is required to follow the prescription when dispensing, retailing and using these drugs for the outpatients;

Article 3. Principle to develop the “List of OTC drugs”

1. The list of OTC drugs is developed on the basis of specific criteria of pharmacological properties and safety of the drug.

2. The list of OTC drugs is developed in accordance with actual use and supply of drug of Vietnam and with the reference of classification of OTC drugs (Over The Counter) from a number of countries such as Australia, the USA, European countries, Philippines, Singapore and China;

3. The list of OTC is modified and supplemented annually. In case of necessity, in order to ensure the user’s safety, a number of types of drug may be removed from the list of OTC drugs if they have serious adverse effect detected;

Article 4. Criteria for selection of OTC drugs

Drugs simultaneously satisfy the following criteria shall be selected in the list of OTC drugs:

1. The drug has low toxicity, does not generate decomposition products with toxicity has no serious adverse effects (adverse effects are the consequences of death, danger to life and hospitalization is required for treatment or prolonged treatment, causing permanent or severe disability, birth defect, congenital malformation and equivalent consequences, ...) that have been known and / or warned work of these effects.

2. Drugs have wide range of dosage, safety for age groups, little effect on the diagnosis and treatment of diseases that should be monitored clinically.

3. Drugs are indicated for the treatment of common diseases and patients can treat themselves, unnecessary examination, consultation and monitoring from the physician.

4. Simple route and form of administration (mainly the oral and administration) with the content and concentration suitable for self-treatment.

5. Drugs have little interaction with other drugs and common food and beverage;

6. Drugs do not cause the drug dependence.

Article 5. Application of “List of OTC drug”

1. The list of OTC drugs is the basis for classification of OTC drugs and prescription drugs. The OTC drugs are permitted for dispensation, sale and use without prescription;

2. The list of OTC drugs is the legal grounds for the formulation and promulgation of regulations and guidelines for the OTC drugs in registration, production, import, export, circulation, distribution of drug, information of drug advertisements and scope of activities of drug retail establishments.

3. For drugs indicated as contraceptive pills that are classified as OTC drugs in this List, the medical officers shall guide the use of drug prior to dispensation or sale to consumers.

4. Other scopes of application of List of OTC drugs shall be guided in the relevant documents;

Article 6. Implementation organization

1. For drug retail establishments:

From the effective date of this Circular, the drug retail establishments are permitted to retail drugs without prescription for the drugs specified in the List of OTC drugs;

2. For drug production and trading establishments:

a) For dossiers to register drug circulation in Vietnam and dossier to import drug without registration number that have been submitted in the Drug Administration of Vietnam before the effective date of this Circular, the establishments must classify, modify and supplement documents related to the classification of drug under the provisions of this Circular before considering the issuance of registration number or import license;

b) For the drugs that already have their registration number or permitted for import before the effective date of this Circular:

- The drugs that are produced and imported within 12 months from the effective date of this Circular and put into circulation in the market shall be permitted for circulation to the their expiration;

- After 12 months from the effective date of this Circular, the establishments that must classify, update and supplement information on drug labels and drug facts related to the classification of drug under the provisions of this Circular shall be permitted for putting their drugs into circulation on the market;

Article 7. Implementation provision

1. This Circular takes effect 45 days after its signing date;

2. The Drug Administration of Vietnam, the units attached to the Ministry of Health, the Service of Health of provinces and Vietnam pharmaceutical Corporation, the pharmaceutical production and trading businesses, the foreign companies having their operation permit in the pharmaceutical area are liable to execute this Circular;

3. Any difficulty arising during the implementation of this Circular should be promptly reported to the Ministry of Health (Drug Administration of Vietnam) for consideration and settlement./.

 

 

FOR THE MINISTER
DEPUTY MINISTER




Cao Minh Quang

 

LIST OF OTC DRUGS

(Issued together with Circular No. 08/2009/TT-BYT dated July 01, 2009)

1. LIST OF PHARMACEUTICAL DRUGS:

No.

Active ingredient

Route of administration, dosage form, limit of content and concentration

Note

1

Acetylcysteine

Oral administration: various forms

 

2

Acetylleucin

Oral administration: various forms

 

3

Acetylsalicylic acid (Aspirin) of pure form or mixed with vitamin C and / or citric acid and / or sodium bicarbonate and / or sodium salicylate

Oral administration: various forms

Topical administration: various forms

 

4

Alginic acid (sodium alginate) of pure form or mixed with compounds of aluminum and magnesium

Oral administration: various forms

 

5

Amino acid of pure or mixed form (including form mixed with Vitamins)

Oral administration: various forms

Indication: supplemental amino acid and vitamins for body

6

Acid Aminobenzoic (Acid para aminobenzoic)\ Aminobenzoic acid (para aminobenzoic acid)

Oral administration: various forms

 

7

Pure or mixed Benzoic acid

Topical administration

Oral administration: lozenge

 

8

Pure or mixed boric acid

Topical administration

Eye dropsand ointment

 

9

Citric acid mixed with sodium, potassium

Oral administration: various forms

 

10

Cromoglicic acid and forms of Natrium cromoglicat

Eye drops and ointmentand nose drops with concentration limit by Cromoglicic acid ≤ 2%

 

11

Acid Dimecrotic Dimecrotic acid

Oral administration: various forms

 

12

Folic Acid of pure form or mixed with iron and / or vitamins of group B, minerals and Sorbitol

Oral administration: various forms

Indications: prevention of anemia, nutritional supplements

13

Glycyrrhizinic acid(Glycyrrhizinat) mixed with a number of other active susbtances such as Chlorpheniramine maleate, dl-methylephedrin, Caffeine ...

Oral administration: various forms, including forms of lozenge

Topical administration

 

14

Mefenamic acid

Oral administration: various forms

 

15

Salicylic Acid of pure or mixed form in topical finished products (mixed with Lactic acid, precipitated sulfur ...)

Topical administration

 

16

Acyclovir Aciclovir

Dermal drug with concentration of Acyclovir ≤ 5%

 

17

Albendazole

Oral administration: various forms

Indication: worm treatment

18

Dichlorobenzyl alcohol of mixed form in lozenge ingredients

Oral administration: lozenge

 

19

Polyvinyl Alcohol

Topical administration

 

20

Alimemazine tartrate (Trimeprazine tartrate)

Oral administration: various forms

 

21

Allantoin mixed in topical ingredients, Suppository (Cao Cepae fluid; Heparin...) 

Topical administration

Suppository Suppository

 

22

Allatoin mixed with Vitamins and/or Chondroitin 

Eye drops and ointment

 

23

Almagate

Oral administration: various forms

 

24

Ambroxol pure or mixed form in topical finished products of cough, antipyretic or analgesic drug

Oral administration: various forms with limit of active ingredients as follows:

- Divided dose: Ambroxol chlorhydrate ≤ 30 mg/unit

- Undivided dose: Ambroxol chlorhydrate ≤ 0.8% 

 

25

Amyllase of pure form or mixed with Protease and / or lipase and / or Cellulase 

Oral administration: various forms

 

26

Amylmetacresol of mixed form with finished products of lozenge (as essential oil, Bacitracin...)

Oral administration: lozenge

 

27

Argyron

Eye drops and ointment

Topical administration

 

28

Aspartame

Oral administration: various forms

 

29

Aspartate

Oral administration: various forms

 

30

Attapulgit

Oral administration: various forms

 

31

Azelastine

Eye drops and ointment and nose drops

 

32

Silver Sulphadiazine

Topical administration

 

33

Bacillus clausii

Oral administration: various forms

 

34

Freeze-dried bacillus subtilis

Oral administration: various forms

 

35

Bacitracin mixed with a number of active ingredients in finished products of lozenge (mixed with Neomycin sulfate; Amylocain; Tixocortol ...)

Oral administration: lozenge

Oral administration: lozenge

.

36

Beclomethasone dipropionate

Nose drug: form of spray with limited maximum dosage for 01 day ≤ 400mcg (based on active ingredients without salt)

 

37

Benzalkonium mixed in topical finished products (with Choline; salicylic acid; Nystatin; Diiodohydroxyquin ...), in finished products of lozenge

Topical administration

Oral: lozenge

 

38

Benzocaine in mixed form

 

Topical administration: various forms with limited Benzocain ≤ 10%;

Suppository

Oral administration: lozenge

 

39

Benzoyl peroxide of pure form or mixed with iodine and / or sulfur

Topical administration: various forms with limited concentration ≤ 10% 

 

40

Benzydamin HCl of pure or mixed form

Topical administration: oral mucosa cream, mouthwash and throat spray

Oral administration: lozenge

 

41

Benzydamin salicylates of pure or mixed form

Topical administration

 

42

Benzyl benzoate mixed in topical finished products (with essential oil, Isopropyl alcohol ...) 

Topical administration: various forms

Dermal patch

 

43

Berberin

Oral administration: various forms

 

44

Biclotymol of pure form or mixed with Enoxolon and/or Phenylephrine HCl and / or Chlorpheniramine maleate and / or essential oil

Topical administration Nose drug

Oral administration: lozenge

 

45

Bifonazol of pure form or mixed with Urea

Topical administration

 

46

Bisacodyl Bisacodyl

Oral administration: various forms with divided dosage with content ≤ 10mg/unit

 

47

Boldin

Oral administration: various forms

 

48

Bromelain of pure form or mixed with Trypsin

Oral administration: various forms

 

49

Bromhexine HCl of pure or mixed form in finished products of cough, antipyretic and analgesic drug (as with Dextromethorphan HBr; Diphenhydramine; Guaiphenesin ...)

Oral administration: various forms with limited Bromhexin HCl as follows:

- Divided dosage ≤ 8mg/unit;

- Undivided dosage ≤ 0,8%

Suppository

 

50

Brompheniramin maleate of pure or mixed form in finished products of cough, antipyretic and analgesic drug

Oral administration: various forms

 

51

Budesonid

Budesonid

Bufexamac of pure or mixed form in topical finished products, suppository (as with titanium dioxide, bismuth, Subgallat, Lidocaine ...)

Nose drug: form of spray, inhaler and powder for inhalation with a limited maximum dosage for 01 day ≤ 400mcg and packed form≤ 200 dosages

Topical administration

Suppository

 

52

Butoconazol

Topical administration 

 

53

Calcium compounds (except for calcitriol) of single form or mixed with Vitamin D and / or Vitamins and / or Ipriflavon

Oral administration: various forms

Indication: Supplemental calcium for body

54

The compounds of aluminum, magnesium, calcium of pure or mixed form

Oral administration: various forms

Indication: neutralizing gastric acid, gastric and duodenal ulcer treatment,.

55

Iron compounds

Oral administration: various forms

Indication: supplemental iron for body

 

56

Enzymes of pure form or mixed with vitamins

Oral administration: various forms

 

57

Bismuth salts

Oral administration: various forms

 

58

Magnesium salts

Oral administration: various forms

Indications: providing supplemental magnesium for body, neutralizing laxative gastric acid;

59

Trace elements: chromium, copper, potassium, magnesium, manganese, sodium, ...

Oral administration: various forms

Indications: providing supplemental minerals for the body, including mixed forms with vitamins.

60

The essential oil (Menthol, Pinen, Camphor; Cineol, Fenchone, Borneol, anethole, Eucaliptol ...)

Oral administration: various forms

Dermal drug, mouthwash, throat spray and oral mucosa cream

 

61

Calamine of pure or mixed form in topical finished products

Carbinoxamin of pure or mixed form in finished products of cough, antipyretic or analgesic drug (with Pseudoephedrin HCl and/or Bromhexin and/or Paracetamol)

Topical administration

Oral administration: various forms with limited Pseudoephedrin (by base form) as follows:

- Divided dosage: ≤120mg/ unit;

- Unvided dosage: ≤ 0.5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

62

Carbocystein

Oral administration: various forms

 

63

Carbomer

Topical administration

Eye drops and ointment

 

64

Catalase of pure or mixed form in topical finished products (with Neomycin)

Topical administration

 

65

Cetirizin dihydrocloride

Oral administration: various forms

 

66

Cetrimide mixed with a number of active ingredients in topical finished products (Lidocaine, Zinc, Calamine, Aminacrine, essential oil ...)

Topical administration

 

67

Cetrimonium mixed in topical finished products and lozenge (mixed with Lidocaine; Tyrothricin, essential oil ...)

Topical administration

Oral administration: lozenge

 

68

Chitosan (Polyglusam)

Topical administration

 

69

Choline of pure form or mixed with amino acids and vitamins in oral finished products; mixed with salicylic acid, benzalkonium ...in topical finished products

 

Oral administration: various forms

Topical administration

 

 

70

Chondroitin of pure form or mixed with Glucosamine and / or fish oil and / or vitamins and / or amino acid

Oral administration: various forms

 

 

71

Chondroitin mixed with Vitamins

Eye drops and ointment

 

72

Chondroitin mixed in topical finished products

Topical administration

 

73

Ciclopirox olamine

Topical administration

 

74

Cimetidin

Oral administration: divided dosage with limited content of Cimetidin ≤ 200mg/unit

 

75

Cinarizin

Oral administration: various forms

 

76

Cinchocaine mixed in topical finished products, suppository (as with hydrocortisone, neomycin, Esculin ...)

Topical administration

Suppository

 

77

Citrulline

Oral administration: various forms

 

78

Clobetason butyrate

Topical administration

 

79

Clorhexidin

Topical administration

 

80

Clorophyll

Oral administration: various forms

 

81

Clorpheniramine maleate of pure or mixed form in finished products of cough, antipyretic and analgesic drug (mixed with with Phenylephrine HCl, paracetamol, Dextromethorphan HBr ...)

Oral administration: various forms.

Pure form of divided dosage: Clorpheniramine maleate ≤ 4mg/

 

82

Clorpheniramine maleate mixed and/or vitamins

Eye drops and ointment

 

83

Clotrimazol

Topical administration: various forms with limited concentration ≤ 3%

Vaginal tablet

 

84

Coenzyme Q10 of pure form or mixed with Vitamin Chondroitin

Oral administration: various forms

 

85

Crotamiton

Topical administration

 

86

Copper sulfate

Topical administration

 

87

Dequalinium of pure or mixed form in topical finished products and lozenges (Tyrothricin; hydrocortisone; acid Glycyrrhetinic; Lidocaine ...)

Dexbrompheniramin maleat of pure or mixed form in in finished products of cough, antipyretic and analgesic drug

Topical administration

Vaginal tablet

Oral: lozenge

Oral administration: various forms

 

88

Dexbrompheniramin maleat of pure or mixed form in in finished products of cough, antipyretic and analgesic drug

Oral administration: various forms

 

89

Dexibuprofen

Oral administration: various forms

 

90

Dexpanthenol

Eye drops and ointment

Topical administration

 

91

Dextromethorphan HBr of pure or mixed form in in finished products of cough, antipyretic and analgesic drug

Oral administration: various forms with the following limit (by base form):

-Divided form: Dextromethophan ≤ 15mg;

- Undivided form: Dextromethophan ≤ 0.6%;

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

92

Diclofenac of pure form or mixed with Methyl salicylate, essential oil…

Topical administration

Eye drops and ointment (pure form)

 

93

Dicyclomine

Oral administration: various forms

 

94

Diethylphtalat (DEP)

Topical administration

 

 

95

Dimenhydrinate

Oral administration: various forms

 

96

Dimethicone (Dimethylpolysiloxan) of pure form or mixed with với Guaiazulene

Oral administration: various forms

 

97

Dimethicon mixed in topical finished products (with zinc, calamine; Cetrimid ...)

Topical administration

 

 

98

Dimethindene

Oral administration: various forms

Topical administration

 

99

Inosine monophosphate dinatri

Eye drops and ointment

 

100

Diosmectite (Dioctahedral smectite)

Oral administration: various forms

 

101

Diosmin mixed with Hesperidin and/or a number of medicinal glue containing Flavonoid

Oral administration: various forms

 

102

Diphenhydramine hydrochloride or monocitrat

Oral administration: various forms with the following limit (by base form):

- Divided dosage ≤ 50mg/unit;

- Undivided dosage: ≤ 2.5%

 

103

Domperidon

Oral administration: various forms with the following limit:

- Divided dosage ≤ 10mg/ unit;

- Undivided dosage: ≤ 0.1%

 

104

Doxylamin mixed in finished products of cough, antipyretic and analgesic drug (as with Paracetamol;

Pseudoephedrin HCl;

Dextromethorphan HBr; Vitamins...)

Oral administration: various forms with limited Pseudoephedrin as follows (by base form):

- Divided dosage ≤ 120mg/ unit;

- Undivided dosage ≤ 0.5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

105

Econazole of pure form or mixed with Hydrocortison

Topical administration, limited concentration of Hydrocortison by base form≤ 0.05%

 

 

106

Enoxolone of pure or mixed form in topical finished products and lozenges

Topical administration: Dermal drug, oral mucosa cream, mouthwash

Oral administration: lozenge

 

107

Ephedrin HCl

Eye and nose drug: lotion ≤ 1%

 

108

Eprazinon

Oral administration: various forms

 

109

Esdepallethrin mixed in topical finished products (with Piperonyl, Spregal, essential oil…)  

Topical administration

 

110

Estradiol in pure form and mixed with Dydrogesteron 

Oral administration: drug with divided dosage

Indication: contraception

111

Ethanol of pure or mixed form

Topical use (antiseptic alcohol)

Oral administration: mixed form

 

112

Ethinylestradiol in pure form and mixed with Cyproteron

Oral administration: drug with divided dosage

Indication: contraception

113

Ethylestradiol in pure form and mixed with Desogestrel

Oral administration: drug with divided dosage

Indication: contraception

114

Ethylestradiol in pure form and mixed with Gestodene

Oral administration: drug with divided dosage

Indication: contraception

115

Ethylestradiol in pure form and mixed with Levonorgestrel

Oral administration: drug with divided dosage

Indication: contraception

116

Etofenamate

Topical administration

 

117

Famotidin

Oral administration: various forms

To be sold without prescription for 15 days of use

118

Fenticonazol

Topical administration

 

119

Fexofenadin

Oral administration: various forms

 

120

Flurbiprofen

Lozenge

Topical administration

Eye drops and ointment

 

121

Glucosamin of pure form or mixed with Chondroitin and/or with Vitamins

Oral administration: various forms

 

122

Glucose or Dextrose of pure form or mixed with sodium, potassium

Oral administration: various forms

Indication: supplemental sugar and electrolytes.

123

Glycerin of pure or mixed form in topical finished products and Eye drops and ointment (with Polysorbat 80)

Topical administration

Eye drops and ointment

 

124

Glycerol mixed with herbal extracts

Drug of rectal enema

 

125

Guaiphenesin of pure or mixed form in finished products of cough, antipyretic and analgesic drug (with Paracetamol; Pseudoephedrin HCl; Dextromethorphan HBr...) 

Oral administration: various forms with limited Pseudoephedrin (by base form):

- Divided dosage form ≤120mg/ unit;

- Undivided dosage form ≤ 0.5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

126

Hexamidin of pure form or mixed (with Cetrimid, Lidocain, Clotrimazol, Catalase)

Topical administration

 

127

Hexetidin of pure form or mixed (with Benzydamin, Cetylpyridinum, Cholin Salicylat, Methyl salicylat, essential oil...)

Topical administration: dermal drug and mouthwash

 

128

Hydrocortison of pure form or mixed (with Miconazol, Econazol, Tioconazol, Neomycin)

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

 

129

Hydrogen Peroxid of pure form or mixed with Sodium Lauryl Sulfate and / or essential oil ...

Topical administration

 

130

Hydrotalcit

 Oral administration: various forms

 

131

Hydroxypropyl methylcellulose (HPMC)

Eye drops and ointment

 

132

Hypromellose of pure form or mixed with Dextran 70

Eye drops and ointment: various forms

 

133

Ibuprofen

Topical administration

 

134

Ichthammol

Topical administration

 

135

Indomethacin

Topical administration

 

136

Iodide mixed with Potassium iodide and / or benzoic acid and / or salicylic acid

Topical administration with concentration of iodine ≤ 5%

 

137

Isoconazol

Topical administration

 

138

Isopropyl Methylphenol

Topical administration

 

139

Ketoconazol of pure form or mixed with Zinc Pirythion and / or hydrocortisone and / or Trolamin

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

 

140

Ketoprofen

Topical administration

 

141

Zinc oxide, Zinc pyrithion, zinc gluconate, zinc undecylenat of pure or mixed form in topical finished products

Topical administration

 

142

Zinc sulfate

Topical administration

Eye drops and ointment

 

143

Lactic acid bacillus of pure form or mixed with vitamins

Oral administration: various forms

 

144

Lactitol

Oral administration: various forms

 

145

Lactobacllus acidophilus

Oral administration: various forms

 

146

Lactobacllus acidophilus of pure form or mixed with vitamins

Oral administration: various forms

 

147

Lactoserum atomisate (Lactacyd)

Topical administration 

 

148

Lactulose

Oral administration: various forms

 

149

Levocetirizin

Oral administration: various forms

 

150

Levonorgestrel of pure form or mixed with Ethylestradiol

Oral administration: various forms

Indication: contraception

151

Lindan (Benhexachlor, 666, Gamma-BHC) of pure form or mixed with Lidocain

Topical administration with concentration of Lindan ≤ 1%

 

152

Loperamid

Oral administration: various forms with a limited content of divided dosage of Loperamid ≤ 2mg  

 

153

Loratadin of pure form or mixed with Pseudoephedrin HCl

Oral administration: various forms with limited content as follows (by base form):

- Divided dosage:

Loratadin ≤ 10mg/unit;

Pseudoephedrin ≤ 120mg/unit

- Divided dosage:

Loratadin ≤ 0.1%

Pseudoephedrin ≤ 0.5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

154

Loxoprofen

Oral administration: various forms

 

155

Lysozym of pure form or mixed with Tocopherol, Nicotinate, Carbazochrom, Inositol Cetylpyridinium,...

Oral administration: various forms

Topical administration 

 

156

Macrogol

Oral administration: various forms

Drug of rectal enema

 

157

Magaldrat of pure form or mixed with the active ingredients of Aluminum, Magnesium, alginic acid (or alginate salt).

Oral administration: various forms

 

158

Mangiferin

Topical administration 

 

159

Mebendazol 

Oral administration: various forms, with limited content as follows:

- Divided dosage form ≤ 500mg/unit

- Undivided dosage form ≤ 2%

 

160

Mebeverin

Oral administration: divided dosage form ≤ 200mg/unit

 

161

Fungal cellulase

Oral administration: various forms

 

162

Menthol mixed with a number of active ingredients such as mixed essential oil, Methyl Salycilat.... 

Oral administration: various forms

Topical administration: various forms

 

163

Mequinol

Topical administration

 

164

Mequitazine

Oral administration: various forms

Topical administration

 

165

Mercurocrom

Topical administration with packaging specifications ≤ 30ml

To be sold with no more than 2 packaging units/time

166

Methyl salicylate mixed in finished products of lozenge and topical administration (mixed with essential oil…)

Topical administration

Dermal patch

Oral administration: lozenge

 

167

Metronidazol

Topical administration

 

168

Miconazol

Topical administration

Vaginal cream≤ 2%  

 

169

Miconazole mixed with Hydrocortison

Topical administration

Vaginal cream

Miconazol ≤2%; Hydrocortison ≤0.05%

 

170

Minoxidil

Topical administration: various forms with concentration of ≤5%

 

171

Mometasone

Nose drug: ≤ 50 mcg/time of spray with packaging specification≤ 200 dosages/box;

 Topical administration

 

172

Mupirocin

Topical administration

 

173

Myrtol of pure or mixed form in finished products of lozenge

Naphazolin of pure or mixed form in finished products of nose drug such as Diphenylhydramin and/or Procain

Oral administration: various forms

Nose drug with concentration of Naphazolin ≤ 0.05%

 

 

174

Naphazolin mixed in finished products of Eye drops and ointment (Pheniramin; Vitamin glycyrhizinat, Dexpanthenol...)

Eye drops and ointment: various forms with concentration of Naphazolin ≤ 0,1%

 

175

Naproxen

Oral administration: various forms with divided dosage of Naproxen ≤ 250mg/unit

 

 

176

Sodium benzoate of pure or mixed form

Oral administration: various forms

 

177

Sodium bicarbonate of pure or mixed form

Oral administration: various forms

 

178

Sodium carbonate of pure or mixed form

Oral administration: various forms

 

179

Sodium carboxymethylcellulose (Na CMC)

Eye drops and ointment

 

180

Sodium chloride of pure form or mixed with potassium citrate, sodium citrate ...

Oral administration: various forms

Topical administration

Eye drops and ointment and nose drug

 

181

Sodium Docusat

Oral administration: various forms

 

182

Sodium fluoride of mixed form

Topical administration:

Tooth cleaning and mouthwash

 

183

Natri Hyaluronat (Acid Hyaluronic)

Topical administration

 

184

Sodium Monofluorophosphat

Topical administration:

Tooth cleaning and mouthwash

 

185

Sodium salicylate of mixed form

Oral administration: mixed form in lozenges

Topical administration

 

186

Neomycin sulfate mixed in finished products of lozenge (Zinc, Bacitracin; Amylocain ...) and topical finished products

Nomahydrated sodium sulfide + Saccharomyces Cerevisiae

Oral administration:

lozenges

Topical administration

Oral administration: various forms

Topical administration

 

187

Noscarpine

Oral administration: various forms

 

188

Nystatin of pure or mixed form

Topical administration

 

189

Orlistat

Oral administration: various forms

 

190

Ossein hydroxy apatite

Oral administration: various forms

 

191

Oxeladin

Oral administration: various forms

 

182

Oxymemazin

Oral administration: various forms

 

193

Oxymetazoline

Nose drug with concentration ≤ 0,5%

 

194

Pancreatin of pure form or mixed with Simethicon and / or digestive enzymes and / or the vitamins of group B and / or Azintamid

Oral administration: various forms

.

195

Panthenol

Topical administration

Eye drops and ointment

 

196

Paracetamol

Oral administration: various forms

Suppository

Mixed form specified in the List

197

Paracetamol mixed with Ibuprofen and/or Cafeine

 

Oral administration: various forms

 

198

Paracetamol mixed with Loratadin and/or Dextromethorphan HBr

Oral administration: various forms

 

199

Paracetamol mixed with Promethazin HCl

 

Oral administration: various forms with limited content and concentration (by base form) as follows:

- Divided dosage: Promethazin ≤12.5mg/unit;

- Undivided dosage: Promethazin ≤ 0.1%

Suppository

 

200

Paracetamol mixed with Codein

 

Oral administration: various forms with limited Codein (by base form) as follows:

- Divided dosage form≤ 30mg/unit;

- Undivided dosage ≤ 2.5%

Finished products containing Codein are sold without prescription with a maximum amount for 10 days of use.

201

Paracetamol mixed with Pseudoephedrine HCl and/or Vitamin C and/or one of the active ingredients:

Brompheniramin maleate, Chlorpheniramine maleate; Pheniramin maleate; Dexclorpheniramin maleate; Dexbrompheniramin maleate;

Dextromethorphan HBr;

Phenylephrine HCl

Oral administration: various forms with the limit (by base form) as follows: 

- Divided base form: Pseudoephedrin ≤ 120mg/unit;

Dextromethophan ≤ 15mg

- Undivided base form: Pseudoephedrin ≤ 0.5%

Dextromethophan ≤ 0.6%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

202

Pentoxyverin

Oral administration: various forms

 

203

Phenylephrin HCl

Eye drops and ointment and nose drop with concentration ≤ 1%

 

204

Phenylephrin HCl mixed in topical finished products (such as Petrolatum sperti yellow; Mineral oil light; Shark liver oil...)

Topical administration

.

205

Phenylephrin HCl mixed in finished products of cough, antipyretic and analgesic drug

Oral administration: various forms

Suppository

 

206

Phospholipid

Oral administration: various forms

 

207

Picloxydine

Eye drops and ointment

 

208

Piracetam

Oral administration: various forms

 

209

Piroxicam

Topical administration: various forms with concentration ≤ 1%

 

210

Policresulen (Metacresolsulphonic acid-formaldehyde)

Topical administration

Rectal tablets

 

211

Polymethylen glycol 400 of pure form or mixed with Propylen glycol

Eye drops and ointment

 

212

Polysacharid

Oral administration: various forms

 

213

Polytar of pure or mixed form in topical finished products (as Zinc Pyrithion ...)

Topical administration

 

 

214

Povidon Iodin

Topical administration: various forms, including mouthwash with concentration ≤ 1%.

Eye drops and ointment

 

215

Promethazin HCl of pure or mixed in finished products of cough, antipyretic and analgesic drug (with Carbocystein; Paracetamol ...)

Oral administration: various forms with limited contents and concentration of Promethazin (by base form) as follows:

-Divided dosage ≤ 12.5mg/unit;

- Undivided dosage ≤ 0.1%

Topical administration: concentration ≤ 2%

 

216

Pseudoephedrin HCl mixed with Cetirizin

Oral administration: various forms with limited Pseudoephedrin (by base form) as follows:

- Divided dosage ≤ 120mg/unit;

- Undivided dosage ≤ 0.5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

217

Pseudoephedrin HCl mixed in finished products of cough, antipyretic and analgesic drug

Oral administration: various forms with limited Pseudoephedrin (by base form) as follows:

- Divided dosage ≤120mg/ unit;

- Undivided dosage ≤ 0,5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

218

Pyrantel

Oral administration: various forms

Indication: worm treatment

219

Ranitidine

Oral administration: various forms with divided dosage ≤ 75mg

To be sold without prescription for up to 15 days of use

220

Rotundin of pure form or mixed with herbal extract and glue

Oral administration: various forms

 

221

Rotundin of pure form or mixed with Vitamin C and/or herbal extract and glue

Oral administration: various forms

 

222

Saccharomyces boulardic

Oral administration: various forms

 

223

Saccharomyces cerevisiae + Trihydrat Magnesi Sulfat

Oral administration: various forms

 

224

Hyocine (Scopolamin) butylbromid of pure form or mixed with Meclizin hydrochlorid

 

Oral administration: various forms, including the chewable tablets with limited content of divided dosage ≤ 20mg

Dermal patch

 

225

Organic selenium of mixed form in finished products containing Vitamin and minerals

Oral administration: various forms with limited content as follows:

- Selen with divided dosage ≤ 50mcg/ unit

 

226

Selen sulfid

Topical administration

 

227

Silymarin of pure form or mixed with Vitamins and/or herbal extract and glue

Oral administration: various forms

 

228

Simethicone of pure form or mixed with Pancreatin and / or Desoxycholic acid and / or vitamin of group B and / or digestive enzymes

Oral administration: various forms

 

229

Simethicon mixed with the aluminum compound, magnesium, and / or dicyclomine and / or activated carbon

Oral administration: various forms

 

230

Sorbitol of pure or mixed form

Oral administration: various forms

 

231

Sterculia (gum sterculia)

Oral administration: various forms

Drug of rectal enema

 

232

Sucralfate

Oral administration: various forms

 

233

Sulbutiamine

Oral administration: various forms

 

234

Sulfogaiacol of pure or mixed form in finished products of cough, antipyretic and analgesic drug (as mixed with Sodium benzoate, Dextromethophan ...)

Oral administration: various forms

 

235

Terbinafine

Topical administration: various forms with concentration ≤ 1%

 

236

Terpin of pure form or mixed with Codeine

 

Oral administration: various forms.

Mixed form of Codeine (by base form) with limited content as follows:

- Divided dosage ≤ 30mg/unit;

- Divided dosage ≤ 2.5%

Finished products containing Codeine are sold without prescription with a maximum amount for 10 days of use.

237

Tetrahydrozoline

Nose drug

 

238

Activated carbon of pure form or mixed with Simethicone

Tioconazol of pure form or mixed with Hydrocortisone

Oral administration: various forms

Topical administration: various forms with concentration as follows:

- Tioconazol ≤ 1.00%

- Hydrocortison ≤ 0.05%

 

 

239

Tolnaftate

Topical administration

 

240

Tretinoin

Topical administration: various forms with concentration ≤ 0.05%

 

241

Triclosan of pure or mixed form in topical finished products

Topical administration

 

242

Triprolidine of pure or mixed form in finished products of cough, antipyretic and analgesic drug (as with Guaiphenesin, Paracetamol, Pseudoephedrin HCl, Dextromethophan HBr...)

 

Oral administration: various forms with limited Pseudoephedrin (by base form) as follows:

- Divided dosage ≤120mg/ unit;

- Undivided dosage ≤ 0.5%

Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.

243

Trolamine of pure or mixed form in topical finished products (with Triclosan and/or Tyrothricin)

Topical administration

 

244

Tyrothricin of mixed form (with Benzalkonium, Benzocain, Formaldehyd, Trolamin, essential oil...)

 

Oral administration: lozenge

Topical administration: Mouthwash and mouth spray

 

245

Urea of pure form or mixed with Vitamin E and/or Bifonazol and/or medicinal materials (Aloe glue)

Topical administration

 

246

Vitamin A and provitamin A (Betacaroten)

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

Topical administration

Eye drops and ointment

 

247

Vitamin of group B, Vitamin PP of pure or mixed form

Eye drops and ointment

 

248

Vitamin and provitamin of pure form (excluding Vitamin A and Article) or mixed with Vitamins, minerals, amino acids, Taurine, fatty acid.

Oral administration: Vitamin A of mixed form ≤ 5000 IU/dosage unit

Topical administration  

With the effect of supplemental vitamins, minerals and nutrients.

249

Methylene blue

Topical administration  

 

250

Xylometazolin of pure form or mixed with Benzalkonium. 

Nose drug with concentration of Xylometazolin ≤ 1%

 

2. LIST OF DRUGS ORIGINATED FROM MEDICINAL MATERIALS:

Drugs originated from medicinal materials whose ingredients do not contain high toxic medicinal materials (Ex: nux vomica, monkshood, gelsemium elegans benth, nerium oleander, strychnos wallichiana steud,…) or medicinal materials having serious adverse effects known/warned of these effects are classified as OTC drugs;

Drugs originated from medicinal materials whose ingredients contain high toxic medicinal materials (Ex: nux vomica, monkshood, gelsemium elegans benth, nerium oleander, strychnos wallichiana steud,…) or medicinal materials having serious adverse effects known/warned of these effect are classified according to each specific case;

The Ministry of Health shall issue a list of highly toxic medicinal materials with serious adverse effects known and / or warned of these effects

 

 

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