Pháp lý doanh nghiệp 
Thông tư 08/2009/TT-BYT của Bộ Y tế ban hành Danh mục thuốc không kê đơn
- Tổng hợp lại tất cả các quy định pháp luật còn hiệu lực áp dụng từ văn bản gốc và các văn bản sửa đổi, bổ sung, đính chính…
- Khách hàng chỉ cần xem Nội dung MIX, có thể nắm bắt toàn bộ quy định pháp luật hiện hành còn áp dụng, cho dù văn bản gốc đã qua nhiều lần chỉnh sửa, bổ sung.
thuộc tính Thông tư 08/2009/TT-BYT
| Cơ quan ban hành: | Bộ Y tế |
| Số công báo: | Đã biết Vui lòng đăng nhập tài khoản gói Tiêu chuẩn hoặc Nâng cao để xem Số công báo. Nếu chưa có tài khoản Quý khách đăng ký tại đây! |
| Số hiệu: | 08/2009/TT-BYT |
| Ngày đăng công báo: | Đã biết Vui lòng đăng nhập tài khoản gói Tiêu chuẩn hoặc Nâng cao để xem Ngày đăng công báo. Nếu chưa có tài khoản Quý khách đăng ký tại đây! |
| Loại văn bản: | Thông tư |
| Người ký: | Cao Minh Quang |
| Ngày ban hành: | 01/07/2009 |
| Ngày hết hiệu lực: | Đã biết Vui lòng đăng nhập tài khoản gói Tiêu chuẩn hoặc Nâng cao để xem Ngày hết hiệu lực. Nếu chưa có tài khoản Quý khách đăng ký tại đây! |
| Áp dụng: | |
| Tình trạng hiệu lực: | Đã biết Vui lòng đăng nhập tài khoản gói Tiêu chuẩn hoặc Nâng cao để xem Tình trạng hiệu lực. Nếu chưa có tài khoản Quý khách đăng ký tại đây! |
| Lĩnh vực: | Y tế-Sức khỏe |
TÓM TẮT VĂN BẢN
Nội dung tóm tắt đang được cập nhật, Quý khách vui lòng quay lại sau!
tải Thông tư 08/2009/TT-BYT
THÔNG TƯ
CỦA BỘ Y TẾ SỐ 08/2009/TT-BYT NGÀY 01 THÁNG 7 NĂM 2009
BAN HÀNH DANH MỤC THUỐC KHÔNG KÊ ĐƠN
Căn cứ Nghị định số 188/2007/NĐ-CP ngày 27 tháng 12 năm 2007 của Chính phủ quy định chức năng, nhiệm vụ, quyền hạn và tổ chức bộ máy Bộ Y tế;
Căn cứ Luật Dược số 34/2005/QH11 ngày 14 tháng 6 năm 2005;
Để đảm bảo an toàn cho người sử dụng thuốc đồng thời tạo điều kiện thuận lợi cho người bệnh có thể mua thuốc tự điều trị các bệnh nhẹ và triệu chứng thông thường, Bộ Y tế ban hành và hướng dẫn thực hiện "Danh mục thuốc không kê đơn" như sau:
Điều 1. Ban hành kèm theo Thông tư này "Danh mục thuốc không kê đơn", bao gồm:
1. Danh mục thuốc hoá dược;
2. Danh mục thuốc có nguồn gốc từ dược liệu.
Điều 2. Giải thích từ ngữ
1. Thuốc không kê đơn là thuốc khi cấp phát, bán và sử dụng không cần đơn thuốc.
2. Thuốc kê đơn là thuốc nếu sử dụng không theo đúng chỉ định của người kê đơn thì có thể nguy hiểm tới tính mạng, sức khoẻ; khi cấp phát, bán lẻ, sử dụng cho bệnh nhân ngoại trú phải theo đơn thuốc.
Điều 3. Nguyên tắc xây dựng "Danh mục thuốc không kê đơn"
1. Danh mục thuốc không kê đơn được xây dựng trên cơ sở các tiêu chí cụ thể về tính chất dược lý và tính an toàn của thuốc.
2. Danh mục thuốc không kê đơn được xây dựng phù hợp với thực tế sử dụng, cung ứng thuốc của Việt Nam và được tham khảo cách phân loại thuốc không kê đơn (Over The Counter - OTC) của một số nước như Australia, Mỹ, một số nước Châu Âu, Philippines, Singapore, Trung Quốc.
3. Danh mục thuốc không kê đơn được sửa đổi, bổ sung hàng năm. Trong trường hợp cần thiết, để đảm bảo an toàn cho người sử dụng, một số loại thuốc có thể bị loại bỏ khỏi danh mục thuốc không kê đơn nếu có những tác dụng có hạinghiêm trọng được phát hiện.
Điều 4. Tiêu chí lựa chọn thuốc không kê đơn
Thuốc đáp ứng đồng thời các tiêu chí sau được lựa chọn vào Danh mục thuốc không kê đơn:
1. Thuốc có độc tính thấp, không tạo ra các sản phẩm phân huỷ có độc tính, không có những tác dụng có hại nghiêm trọng (là những tác dụng có hại gây hậu quả tử vong, nguy hiểm đến tính mạng, cần phải nhập viện để điều trị hay kéo dài thời gian điều trị, gây tàn tật vĩnh viễn hay nặng nề, sinh con dị dạng, dị tật bẩm sinh và các hậu quả tương đương,...) đã được biết và/hoặc khuyến cáo có tác dụng này.
2. Thuốc có phạm vi liều dùng rộng, an toàn cho các nhóm tuổi, ít có ảnh hưởng đến việc chẩn đoán và điều trị các bệnh cần theo dõi lâm sàng.
3. Thuốc được chỉ định trong điều trị các bệnh thông thường và bệnh nhân có thể tự điều trị, không nhất thiết phải có sự thăm khám, tư vấn và theo dõi của thầy thuốc.
4. Đường dùng, dạng dùng đơn giản (chủ yếu là đường uống, dùng ngoài da) với hàm lượng, nồng độ thích hợp cho việc tự điều trị.
5. Thuốc ít tương tác với các thuốc khác và thức ăn, đồ uống thông dụng.
6. Thuốc không gây tình trạng lệ thuộc.
Điều 5. Áp dụng "Danh mục thuốc không kê đơn"
1. Danh mục thuốc không kê đơn là căn cứ để phân loại thuốc không kê đơn và thuốc kê đơn. Thuốc không kê đơn được phép cấp phát, bán và sử dụng không cần đơn thuốc.
2. Danh mục thuốc không kê đơn là cơ sở pháp lý để xây dựng và ban hành các quy định, hướng dẫn đối với thuốc không kê đơn trong đăng ký thuốc, sản xuất, xuất khẩu, nhập khẩu, lưu thông phân phối thuốc, thông tin quảng cáo thuốc và phạm vi hoạt động của các cơ sở bán lẻ thuốc.
3. Đối với các thuốc có chỉ định tránh thai được phân loại là thuốc không kê đơn trong Danh mục này, cán bộ y tế phải có trách nhiệm hướng dẫn sử dụng thuốc trước khi cấp, phát hoặc bán cho người tiêu dùng.
4. Các phạm vi áp dụng khác của Danh mục thuốc không kê đơn sẽ được hướng dẫn cụ thể trong các văn bản liên quan.
Điều 6. Tổ chức thực hiện
1. Đối với cơ sở bán lẻ thuốc:
Kể từ ngày Thông tư này có hiệu lực, các cơ sở bán lẻ được phép bán lẻ không cần đơn thuốc đối với các thuốc trong danh mục thuốc không kê đơn.
2. Đối với cơ sở sản xuất, kinh doanh thuốc:
a) Đối với hồ sơ đăng ký lưu hành thuốc tại Việt Nam và hồ sơ nhập khẩu thuốc chưa có số đăng ký đã nộp tại Cục Quản lý dược trước ngày Thông tư này có hiệu lực, các cơ sở phải tiến hành thực hiện việc phân loại, sửa đổi, bổ sung các tài liệu có liên quan đến việc phân loại thuốc theo quy định tại Thông tư này trước khi xem xét cấp số đăng ký hoặc giấy phép nhập khẩu.
b) Đối với các thuốc đã có số đăng ký lưu hành hoặc được phép nhập khẩu trước ngày Thông tư này có hiệu lực:
- Các thuốc được sản xuất, nhập khẩu trong thời hạn 12 tháng kể từ ngày Thông tư này có hiệu lực mà đã đưa ra lưu thông trên thị trường thì được phép lưu thông đến hết hạn dùng của thuốc.
- Sau 12 tháng kể từ ngày Thông tư này có hiệu lực, các cơ sở phải phân loại, cập nhật, bổ sung các thông tin trên nhãn, tờ hướng dẫn sử dụng thuốc liên quan đến việc phân loại thuốc theo quy định tại Thông tư này mới được phép đưa thuốc ra lưu thông trên thị trường.
Điều 7. Điều khoản thi hành
1. Thông tư này có hiệu lực thi hành sau 45 ngày kể từ ngày ký ban hành.
2. Cục Quản lý dược, các đơn vị trực thuộc Bộ Y tế, Sở Y tế các tỉnh, thành phố trực thuộc trung ương, Tổng cụng ty dược Việt Nam, các doanh nghiệp sản xuất, kinh doanh dược phẩm, các công ty nước ngoài có giấy phép hoạt động trong lĩnh vực dươc có trách nhiệm thực hiện thông tư này
3. Trong quá trình thực hiện nếu có vấn đề vướng mắc, đề nghị các tổ chức, cá nhân kịp thời phản ánh về Bộ Y tế (Cục Quản lý dược) để xem xét, giải quyết.
KT. BỘ TRƯỞNG
THỨ TRƯỞNG
Cao Minh Quang
THE MINISTRY OF HEALTH No. : 08/2009/TT-BYT | SOCIALIST REPUBLIC OF VIETNAM 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 |
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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