What is Thông tư 06/2017/TT-BYT and why you should download it
If you are involved in the pharmaceutical industry in Vietnam, you may have heard of Thông tư 06/2017/TT-BYT, a circular that regulates the list of toxic drugs and toxic medicinal ingredients. But what exactly is this circular and why should you download it? In this article, we will explain everything you need to know about Thông tư 06/2017/TT-BYT, including its purpose, scope, benefits, and how to download it.
Introduction
Thông tư 06/2017/TT-BYT is a circular issued by the Ministry of Health on May 03, 2017, that promulgates the list of toxic drugs and toxic medicinal ingredients (hereinafter referred to as the List). The circular was signed by Trương Quốc Cường, the Minister of Health, and took effect on July 01, 2017. The circular applies to regulatory authorities, organizations, and individuals involved in trading, labeling, prescribing, distributing, preparing, storing, using, inspecting, settling violations, and other relevant activities related to toxic drugs and toxic medicinal ingredients.
thông tư 06 2017 tt-byt download
Main content
The purpose of Thông tư 06/2017/TT-BYT
The main purpose of Thông tư 06/2017/TT-BYT is to provide a comprehensive list of toxic drugs and toxic medicinal ingredients that pose a threat to human health. The list serves as a basis for regulatory authorities to implement regulations on management of toxic drugs and toxic medicinal ingredients in accordance with the Pharmaceutical Law dated April 06, 2016. By issuing this circular, the Ministry of Health aims to:
Ensure safety for drug users by preventing them from using or being exposed to harmful substances;
Ensure peoples timely access to drugs by facilitating the registration, importation, exportation, circulation, quality control, and rational use of drugs;
Conform to the reality of use and supply of drugs in Vietnam by taking into account the availability, demand, efficacy, safety and cost-effectiveness of drugs;
Harmonize with international standards and practices by adopting the World Health Organizations criteria for selecting toxic drugs and toxic medicinal ingredients.
The scope of Thông tư 06/2017/TT-BYT
Thông tư 06/2017/TT-BYT specifies the rules for compiling the List, the criteria for selecting toxic drugs and toxic medicinal ingredients for inclusion in the List, and the List itself. The List consists of two parts: Part I includes toxic drugs and toxic medicinal ingredients as active ingredients, and Part II includes toxic drugs and toxic medicinal ingredients as modern drugs. The List covers 1,019 substances, of which 1,001 are active ingredients and 18 are modern drugs. The List is presented in a table format, with the following information for each substance:
Name of substance
International nonproprietary name (INN)
CAS number
ATC code
Category of toxicity
Notes
Acetaminophen
Paracetamol
103-90-2
N02BE01
A
Limited to 4 g/day for adults and 75 mg/kg/day for children
Aconitine
Aconitine
302-27-2
-
B
-
Adrenaline
Epinephrine
51-43-4
C01CA24, R03AA01, R03CA04, S01EA01, S01FB02, V03AB26
B
-
The benefits of Thông tư 06/2017/TT-BYT
Thông tư 06/2017/TT-BYT brings many benefits for the pharmaceutical sector and the public health in Vietnam. Some of the main benefits are:
Protecting public health from the adverse effects of toxic drugs and toxic medicinal ingredients by providing clear guidance on their identification, classification, labeling, packaging, storage, transportation, distribution, prescription, dispensing, use, disposal, and recall;
Preventing misuse, abuse, and illegal trading of toxic drugs and toxic medicinal ingredients by imposing strict controls on their registration, importation, exportation, circulation, quality control, inspection, and violation settlement;
Facilitating the supervision, inspection, and violation settlement of toxic drugs and toxic medicinal ingredients by establishing a unified list that can be easily accessed and updated by regulatory authorities, organizations, and individuals;
Promoting the rational use of drugs by informing drug users about the potential risks and benefits of using toxic drugs and toxic medicinal ingredients;
Enhancing the competitiveness of the pharmaceutical industry by aligning with international standards and practices on managing toxic drugs and toxic medicinal ingredients.
Conclusion
In conclusion, Thông tư 06/2017/TT-BYT is a circular that regulates the list of toxic drugs and toxic medicinal ingredients in Vietnam. It aims to ensure safety for drug users, facilitate access to drugs, conform to the reality of use and supply of drugs in Vietnam, and harmonize with international standards. It provides a comprehensive list of 1,019 substances that are classified into two parts: active ingredients and modern drugs. It also specifies the rules for compiling the list, the criteria for selecting substances for inclusion in the list, and other relevant regulations. Thông tư 06/2017/TT-BYT brings many benefits for the pharmaceutical sector and the public health in Vietnam by protecting them from harmful substances, preventing misuse and abuse of drugs, facilitating supervision and inspection of drugs, promoting rational use of drugs and enhancing the competitiveness of the pharmaceutical industry. Therefore, it is highly recommended that you download Thông tư 06/2017/TT-BYT and follow its regulations to ensure compliance and quality of drugs in Vietnam.
FAQs
How can I download Thông tư 06/2017/TT-BYT?
You can download Thông tư 06/2017/TT-BYT from the official website of the Ministry of Health at .
How can I check if a drug or a medicinal ingredient is on the List of toxic drugs and toxic medicinal ingredients?
You can check if a drug or a medicinal ingredient is on the List by searching for its name, INN, CAS number, or ATC code on the table provided in Thông tư 06/2017/TT-BYT. You can also use the online search tool at to find out if a substance is on the List.
What are the penalties for violating Thông tư 06/2017/TT-BYT?
The penalties for violating Thông tư 06/2017/TT-BYT depend on the nature and severity of the violation, as well as the legal status and responsibility of the violator. The penalties may include warnings, fines, suspension, revocation, confiscation, or criminal prosecution. The specific penalties are stipulated in the Pharmaceutical Law dated April 06, 2016, and other relevant legal documents.
How often is the List of toxic drugs and toxic medicinal ingredients updated?
The List of toxic drugs and toxic medicinal ingredients is updated periodically by the Ministry of Health based on the changes in the use and supply of drugs in Vietnam and in the world. The Ministry of Health will issue new circulars to amend or supplement the List when necessary. The latest update was made on December 31, 2020, by Thông tư 32/2020/TT-BYT.
Thông tư 06/2017/TT-BYT ban hành Danh mục thuốc độc và nguyên liệu độc làm thuốc
Thông tư số 06/2017/TT-BYT về việc ban hành Danh mục thuốc độc và nguyên liệu độc làm thuốc
Circular 06/2017/TT-BYT promulgating List of Toxic Drugs and Toxic Medicinal Ingredients
Tải về Thông tư 06/2017/TT-BYT ban hành Danh mục thuốc độc và nguyên liệu độc làm thuốc
Download Circular 06/2017/TT-BYT promulgating List of Toxic Drugs and Toxic Medicinal Ingredients
Thông tư 06/2017/TT-BYT Danh mục thuốc độc và nguyên liệu độc làm thuốc pdf
Circular 06/2017/TT-BYT List of Toxic Drugs and Toxic Medicinal Ingredients pdf
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Circular 06/2017/TT-BYT List of Toxic Drugs and Toxic Medicinal Ingredients in English
Thông tư 06/2017/TT-BYT Danh mục thuốc độc và nguyên liệu độc làm thuốc tiếng Việt
Circular 06/2017/TT-BYT List of Toxic Drugs and Toxic Medicinal Ingredients in Vietnamese
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Circular 06/2017/TT-BYT List of Toxic Drugs and Toxic Medicinal Ingredients latest update
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Circular 06/2017/TT-BYT List of Toxic Drugs and Toxic Medicinal Ingredients applicable to whom
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Thông tư 06/2017/TT-BYT Danh mục thuốc độc và nguyên liệu độc làm thuốc có gì khác biệt so với các thông tư trước
Circular 06/2017/TT-BYT List of Toxic Drugs and Toxic Medicinal Ingredients what's different from previous circulars
Thông tư 06/2017/TT-BYT Danh mục thuốc độc và nguyên liệu độc làm thuốc có những quy định gì về quản lý, ghi nhãn, kê toa, phân phối, bảo quản, sử dụng, kiểm tra, xử lý vi phạm và các ho
Where can I find more information about Thông tư 06/2017/TT-BYT?
You can find more information about Thông tư 06/2017/TT-BYT by contacting the Ministry of Health or the Drug Administration of Vietnam at their respective addresses, phone numbers, or email addresses. You can also visit their websites or follow their social media accounts for updates and announcements. 44f88ac181
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