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Angel Thompson
Angel Thompson

Tải về Danh mục thuốc độc và nguyên liệu độc làm thuốc theo Thông tư 06/2017/TT-BYT - File Excel


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;