CIRCULAR 07/2017/TT-BYT
CIRCULAR 07/2017/TT-BYT

MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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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 5. Effect

  1. 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.

LIST

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

  1. 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

 

* 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)


III. OTC TRADITIONAL INGREDIENTS
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