| 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 5. Effect
- 1. This Circular takes effect as from July 01, 2017.
- 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)
- 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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