Circular No. 06/2017/TT-BYT promulgates the List of Toxic Drugs and Raw Materials for Drug Production

CIRCULAR

ISSUING THE LIST OF POISONOUS DRUGS AND POISONOUS RAW MATERIALS FOR DRUGS

Pursuant to the Medicine Law dated April 6, 2016;

Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration Department;

The Minister of Health issues the Circular on Issuing the List of Poisonous Drugs and Poisonous Raw Materials for Drugs.

Article 1. Scope of Regulation

This Circular stipulates the principles for establishing and criteria for selecting poisonous drugs and poisonous raw materials for drugs; the List of Poisonous Drugs and Poisonous Raw Materials for Drugs which are pharmaceutical substances and chemical drugs; the purpose of issuance and responsibilities for implementation.

Article 2. Principles for Establishing and Criteria for Selecting Drugs and Raw Materials for Drugs into the List of Poisonous Drugs and Poisonous Raw Materials for Drugs

1. Principles for Establishing the List of Poisonous Drugs and Poisonous Raw Materials for Drugs:

a) Ensuring safety for users;

b) Ensuring timely access to drugs for the public;

c) Being consistent with the actual drug usage and supply situation in Vietnam;

d) Harmonizing with the principles and regulations on classifying poisonous drugs and poisonous raw materials for drugs in countries in the region and worldwide;

đ) Based on the approved drug usage instructions, the National Pharmacopoeia, global drug databases, scientific journal articles, and other relevant materials.

2. Criteria for Selecting Drugs and Raw Materials for Drugs into the List of Poisonous Drugs and Poisonous Raw Materials for Drugs:

Drugs and raw materials for drugs are considered for selection into the List of Poisonous Drugs and Poisonous Raw Materials for Drugs in cases where there is a risk of causing one or more of the following effects on humans:

a) Carcinogenicity (ability to cause cancer);

b) Teratogenicity (ability to cause fetal malformations or developmental toxicity in newborns);

c) Reproductive toxicity;

d) Organ toxicity at low doses;

đ) Genotoxicity (ability to cause genetic mutations).

Article 3. List of Poisonous Drugs and Poisonous Raw Materials for Drugs

The List of Poisonous Drugs and Poisonous Raw Materials for Drugs is issued together with this Circular.

Article 4. Purpose of Issuing the List of Poisonous Drugs and Poisonous Raw Materials for Drugs

Issuing the List of Poisonous Drugs and Poisonous Raw Materials for Drugs serves as a basis for competent state management agencies to implement regulations on managing poisonous drugs and poisonous raw materials for drugs in business operations, labeling, prescription writing, distribution, compounding, storage, use, inspection, supervision, violation handling, and other related activities.

Article 5. Effective Date

This Circular takes effect from July 1, 2017.

Article 6. Transitional Provisions

1. For drugs and raw materials for drugs that have been granted circulation registration certificates or import permits before the effective date of this Circular, the entities named on the circulation registration certificates, and drug importers must classify, update, and supplement information related to drug classification according to the provisions of this Circular on labels and drug usage instructions in accordance with the timeline specified in the Circular on Drug Labeling issued by the Minister of Health prior to placing the drugs and raw materials for drugs on the market.

2. For drugs and pharmaceutical substances with registration files in Vietnam or import drug registration files submitted to the Drug Administration before the effective date of this Circular but not yet granted circulation registration certificates or import permits, they must be classified according to the provisions of this Circular.

Article 7. Responsibility for Implementation

1. Responsibilities of Pharmaceutical Entities and Medical Examination and Treatment Facilities:

a) Implement the regulations on managing poisonous drugs and poisonous raw materials for drugs listed in Article 3 of this Circular as detailed in the Circular on Certain Provisions of the Pharmacy Law Regarding Special-Controlled Drugs issued by the Minister of Health;

b) Propose amendments and supplements to the List of Poisonous Drugs and Poisonous Raw Materials for Drugs to ensure timely availability of drugs for disease prevention and treatment in line with practical needs.

2. Responsibilities of the Drug Administration Department:

a) Take the lead and coordinate with relevant agencies to implement this Circular;

b) Review the List of Poisonous Drugs and Poisonous Raw Materials for Drugs and report to the Minister of Health based on proposals for amendments and supplements from the entities specified in Clause 1 of this Article or conclusions of the Advisory Council for Granting Circulation Registration Certificates for Drugs and Raw Materials for Drugs.

During the implementation process, if any issues arise, it is requested that agencies, organizations, and individuals promptly reflect them to the Drug Administration (Ministry of Health) for consideration and resolution./.