Circular No. 07/2017/TT-BYT dated May 03, 2017 of the Ministry of Health on the Promulgation of List of OTC drugs

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Issuing body:	Ministry of Health	Effective date:	Known Please log in to a subscriber account to use this function. Don’t have an account? Register here
Official number:	07/2017/TT-BYT	Signer:	Truong Quoc Cuong
Type:	Circular	Expiry date:	Updating
Issuing date:	03/05/2017	Effect status:	Known Please log in to a subscriber account to use this function. Don’t have an account? Register here
Fields:	Medical - Health

SUMMARY

Promulgation of List of OTC drugs

On May 03, 2017, the Ministry of Health issued the Circular No. 07/2017/TT-BYT on Promulgation of List of OTC drugs, takes effect on July 01, 2017.

Accordingly, 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

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;

Drugs of which the administration routes and dosage forms are simple (oral, topical administration), and the concentration are appropriate for self-treatment by patients; drugs that rarely interact with other drugs or common foods and drinks; drugs that do not cause dependence; drugs that do not pose risks of overdose or misuse affecting the safety of drug users; drugs that have been selling in Vietnam for at least 05 years.

The List includes 243 OTC modern drugs and biological, within that Vitamin A and provitamin A (Betacarotene) as a single substance or combined with vitamins, Panthenol; Paracetamol as a single substance; Enzymes as a single substance or combined with other substances…

This Circular replaces the Circular No. 23/2014/TT-BYT dated June 30, 2014.

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Effect status: Known

THE MINISTRY OF HEALTH

Circular No.07/2017/TT-BYT datedMay03, 2017of the Ministry of Health on the Promulgation of List of OTC drugs

Pursuant to thePharmaceuticalLawdated April 06, 2016;

Pursuant to the Government’s Decree No. 63/2012/ND-CPdated August31,2012 defining Functions, Tasks, Powers and Organizational Structure of Ministry ofHealth;

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

Article 1. Scopeof adjustment

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 haveserious adverse reactionsthat are known or warned againstby 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;

-Causecongenital 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 withoutprescription and monitoringfrommedical practitioners;

d) Drugs of which the administration routes and dosage forms are simple (oral, topical administration), and the concentration are appropriate for self-treatmentby 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 ofList 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 theList of OTC drugsmust be classified asprescription drugs.

2. TheList of OTC drugs is the basis for formulation and promulgation of regulations and instructionsby regulatory authoritieson 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 effectonfrom July 01, 2017.

2.TheCircular No. 23/2014/TT-BYTdated June 30, 2014 by Minister of Health on promulgation of List of OTC drugsshall be null and void as from thedate ofentry into force of thisCircular.

Article 6. Transitional provisions

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 numbersin Vietnamor 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-BYTbut 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 arenoton 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 importersare encouraged toclassify, update and provide additional information concerning drug classificationsin accordance with regulations herein on drug labels and package inserts beforesellingdrugs 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 responsibilities

1.Responsibility of pharmacy establishments and health facilities:

a)Implement regulationsherein;

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 theDrug Administration of Vietnam:

a)Take charge of and cooperate withregulatory bodiesin 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 withtheDrug Administration of Vietnamandregulatory 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 ofunitsmentioned in Clause 1 herein or conclusion of the Advisory Council for issuance of certificate of free sale of drugs and medicinal ingredients.

Any difficulties arising in the course ofimplementation of this Circular should be promptly reported to the Drug Administration of Vietnamor theTraditional Medicine Administration of Vietnam(if related to traditional medicines)for consideration./.

For the Minister

The Deputy Minister

Truong Quoc Cuong

LIST

OF OTC DRUGS
(Enclosed withthe Circular No. 07/2017/TT-BYTdated May 03, 2017 by Minister of Health)

I. LIST OF OTC MODERN DRUGS AND BIOLOGICALS

No.	Active ingredients	Administrationroute, 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, includinglozenges Topical administration
14	Lactic acid as a single substance or combined with other substances	Topical administration
15	Mefenamicacid	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	Sulphadiazinsilver	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 Nsaladministration 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	Bismuthsalt	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 BromhexinHydrochloridecontent: - Divided dose: ≤8mg/unit; -Undivided dose:≤ 0,8% Rectal suppositories
49	Bromelainas 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 ofcalcium
57	Carbinoxamine as a single substance or combined with PseudoephedrinHydrochlorideand/or Bromhexin and/or Paracetamol in cough medicines, antipyretic drugs, pain relievers	Oral administration	Not more than 15 days’ dose of products that containPseudoephedrinmay 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 Borneoland/orVitamins	Intravitreal administration Topical administration
68	Ciclopirox olamin	Topical administration
69	Cimetidin	Oral administration: divided dose withlimitedconcentrationofCimetidin ≤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 dosein 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 mustrecord buyers’ names and addresses
80	Coenzym Q10 as a single substance or combined with Vitamins	Oral administration: various forms
81	Crotamiton	Topical administration
82	Dequaliniumas a single substance orcombined with Tyrothricin, Hydrocortison,GlycyrrhetinicAcid,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 withZinc,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 followingconcentrationlimits (bases): - Divided dose: ≤50mg/unit; - Undivided dose: ≤ 2.5%
98	Sulfatecopper	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 Pseudoephedrinmay besold without prescription Retailers must record buyers’ names and addresses
100	Econazol as a single substance or combined withHydrocortison	Topical administration: withHydrocortisonconcentration(bases)≤ 0.05%
101	Enoxolon as a single substance or combined withother substances intopical 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 oilin 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 ofdrugsmay 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	GlucoseorDextrose as a single substance or combined withsodium orpotassium	Oral administration: various forms	Indications: supplementation ofsugar orelectrolyte
115	Glycerin as a single substance or combined with Polysorbat80 intopical productsor eye drops	Topical administration Intravitreal administration
116	Glycerolcombined with herbal extracts	Enema
117	Guaiphenesinas a single substance or combined with other ingredientson 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, ClotrimazolorCatalase	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	Hydrocortisonas a single substance or combined with Miconazol, Econazol, Tioconazol, Neomycin	Topical administration: various forms with concentrationof 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, includingchewable tablets Concentration≤ 20mg/ divided dose Transdermal patch
124	Hydroxypropyl methylcellulose (Hypromellose, HPMC)as a single substance or combined withDextran 70and/orCarbomer	Intravitreal administration: various forms
125	Ibuprofen	Oral administration: verious formswithconcentration ≤400mg/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:Iodineconcentration ≤ 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 PirythionZinc and/or Hydrocortison and/orTrolamin	Topical administration: various forms with concentrationofKetoconazol ≤ 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 PseudoephedrinHydrochlorid and/orParacetamol	Oral administration: various forms with the followingconcentrationlimits (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(orAlginatsalt).	Oral administration: various forms
148	Magnesiincluding salts or compounds of magnesium	Oral administration: various forms	Indications: supplementation ofmagnesium, gastric acid neutralization, laxatives.
149	Mangiferin	Topical administration
150	Mebendazol	Oral administration: various forms with the followingconcentrationlimits: - Divided dose: ≤500mg/unit - Undivided dose: ≤ 2%
151	Mebeverin	Oral administration: divided dose: ≤200mg/unit
152	Cellulase fongique	Oral administration: various forms
153	Enzymesas a single substance or combined with other substances (including combinations with vitamins)	Oral administration: various forms
154	Mentholcombined with other active ingredients suchas 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: ≤ 30mlper pack	Not more than 2 packs may be sold without prescription
158	Methyl salicylat combined withessential 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 Diphenylhydraminand/orProcainin nasally administered drugs	Nasal administration withNaphazolinconcentration≤ 0.05%
167	Naphazolincombined withPheniramin; Vitamin glycyrhizinat, Dexpanthenol, etc. in eye drops	Intravitrealadministration: various formswith Naphazolin concentration ≤ 0.1%
168	Naproxen	Oral administration: verious formswith concentration≤ 275mg/divided dose
169	Sodiumbenzoateas a single substance or combined with other substances	Oral administration: various forms
170	Sodiumbicacbonateas a single substance or combined with other substances	Oral administration: various forms
171	Sodiumcarbonateas a single substance or combined with other substances	Oral administration: various forms
172	SodiumCarboxymethylcellulose (Na CMC)	Intravitreal administration
173	SodiumChloride as a single substance or combined with Potassium Citrate, Sodium citrate, etc.	Oral administration: various forms Topical administration Intravitreal administration, nasal administration withconcentration≤ 0.9%
174	SodiumDocusat	Oral administration: various forms
175	Sodium Fluoridecombined with other ingredients	Topical administration: toothpaste, mouthwash
176	Sodium Hyaluronat (Hyaluronic acid)	Topical administration Eye dropswith concentration ≤ 0.1%
177	SodiumMonofluorophosphate	Topical administration, including products for cleaning the oral cavity, mucous membrane
178	Sodium Salicylatecombined with other ingredients	Oral administration:combined with otheringredientsin 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 ofminerals
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 ≤20mgper 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 ingredientsthat have limited concentrations and may be retailed only once must comply with corresponding regulations applied thereto
195	Pentoxyverin	Oral administration: various forms
196	PhenylephrineHydrochloride	Intravitreal administration, nasal administration with concentration ≤ 1%
197	PhenylephrineHydrochloride combinedwith other ingredients in topical products (such as Petrolatum sperti yellow; Mineral oil light; Shark liver oil, etc.)	Topical administration
198	PhenylephrineHydrochloride combinedwith 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 Rectalsuppositories
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 mouthwashwith 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	PseudoephedrinHydrochloridecombined 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 relieversand 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 withVitamin Cand/orherbal extracts	Oral administration: various forms
213	Saccharomyces boulardic	Oral administration: various forms
214	Saccharomyces cerevisiaecombined withTrihydrat 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 ofiron.
216	Organicselenium combined with vitamins or minerals	Oral administration: various forms with the following concentration limits: - Divided doseofselenium: ≤50mcg/unit
217	Seleniumsulfide	Topical administration
218	Silymarin as a single substance or combined with Vitamin and/or herbalingredients	Oral administration: various forms
219	Simethicon as a single substance or combined with Pancreatinand/orDesoxycholicAcidand/or B vitamins and/orenzymes	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 otheringredientsin 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 carbonas 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 withthe followingconcentrationlimits: - Tioconazol ≤ 1.00% - Hydrocortison ≤ 0.05%
232	Tolnaftate	Topical administration
233	Triclosan as a single substance or combined withother ingredients intopical products	Topical administration
234	Triprolidin as a single substance or combined with otheringredientsin 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(withTriclosanand/orTyrothricin)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 VitaminE and/orBifonazoland/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 withVitamin Aconcentration ≤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 withBenzalkonium.	Nsal administration with Xylometazolin concentration ≤ 1%

* With regard to contraception drugs on this List, drug retailers who arebachelors of pharmacyor 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 tumor;

b) Treatment of cardiovascular diseases or blood pressure diseases;

c) Treatment of liver, biliary orpancreasdiseases (excluding liver tonics);

d) Treatment ofParkinsondisease;

dd) Treatment of viral infection;

e) Treatment of fungal infections (excludingtopicalantifungal medications);

g) Treatment oftuberculosis;

h) Treatment of malaria;

i) Treatment ofgout;

k) Treatment of asthma;

l) Treatment ofendocrinediseases;

m) Treatment ofblood disorders ordiseases;

n) Treatment of blood disorders or diseases;

o) Treatment of kidneyand genitourinary systemdiseases (excluding kidney yang tonics);

p) Treatment ofbacterial contaminationdiseases (excluding topical antibiotics);

q) Treatment of chronicinsomnia;

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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Circular No. 07/2017/TT-BYT dated May 03, 2017 of the Ministry of Health on the Promulgation of List of OTC drugs

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