Circular No. 20/2017/TT-BYT provides detailed regulations on certain provisions of the Drug Law and Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government regarding special control drugs and drug precursors.

CIRCULAR

Detailed regulations on some provisions of the Drug Law and Government Decree No.

54/2017/ND-CP dated May 8, 2017 of the Government

for drugs and raw materials for drugs subject to special control

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Decree No. 63/2012/NĐ-CP dated 31 ENVIRONMENTJune 2024;energy 8 For power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract.amend1. During the period when Circular No. 08/2022/TT-BKHĐT and Circular No. 10/2022/TT-BKHĐT are suspended, the following legal documents and regulations continue to be effective:12 of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Health;

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

Minister of "d) The original or a certified copy of the discharge summary or a summary of the medical record as prescribed in Appendix 3 and Appendix 4 issued together with this Circular. If the worker has not been hospitalized or treated as an outpatient, they must have documents related to the examination and treatment of occupational injuries or diseases corresponding to the time of the accident and the injury for which assessment is requested. promulgating this Circular detailing some provisions of the Drug Law and Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government for drugs and raw materials for drugs subject to special control.

 PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates on:

1. The relevant lists concerning drugs and raw materials for drugs subject to special control include:

a) The list of narcotic drug substances as prescribed in Appendix I attached hereto and the table of concentration and quantity limits of narcotic drug substances in combined drugs as prescribed in Appendix IV attached hereto;

b) The list of psychotropic drug substances as prescribed in Appendix II attached hereto and the table of concentration and quantity limits of psychotropic drug substances in combined drugs as prescribed in Appendix V attached hereto;

c) The list of precursor substances used in drugs as prescribed in Appendix III attached hereto and the table of concentration and quantity limits of precursor substances used in drugs in combined drugs as prescribed in Appendix VI attached hereto;

d) The list of drugs and drug substances included in the list of prohibited substances for use in certain sectors and fields as prescribed in Appendix VII attached hereto.

2. Activities related to storage, production, compounding, distribution, use, disposal, receipt and delivery, transportation, and reporting on drugs and raw materials for drugs subject to special control.

3. Activities related to the supply of radioactive drugs.

4. Documents, ledgers, and retention of vouchers and documents related to drugs and raw materials for drugs subject to special control.

Article 2. Applicability

1. The provisions regarding the relevant lists concerning drugs and raw materials for drugs subject to special control and documents, ledgers, and retention of vouchers and documents related to drugs and raw materials for drugs subject to special control stipulated in this Circular apply to all pharmaceutical business establishments and other entities as prescribed in Clause 2 of this Article.

2. The provisions regarding activities related to storage, production, compounding, distribution, use, disposal, receipt and delivery, transportation, and reporting on drugs and raw materials for drugs subject to special control stipulated in this Circular only apply to the following entities:

a) Medical examination and treatment facilities;

b) Compulsory detoxification centers;

c) Research and training institutions specializing in medicine and pharmacy;

d) Entities engaged in pharmaceutical activities not for commercial purposes.

3. The provisions regarding activities related to the supply of radioactive drugs stipulated in this Circular only apply to medical facilities that produce and compound radioactive drugs.

Article 3. Classification of drugs subject to special control

1. Narcotic drugs include the following types:

a) Containing one or more narcotic drug substances or drugs containing narcotic drug substances combined with psychotropic drug substances and may or may not contain precursor substances used in drugs as prescribed in Appendices I, II, and III attached hereto.

b) Containing narcotic drug substances (with or without psychotropic drug substances, precursor substances used in drugs) combined with other drug substances that are not narcotic drug substances, psychotropic drug substances, or precursor substances used in drugs, where the concentration and quantity of narcotic drug substances exceed the limits prescribed in Appendix IV attached hereto.

2. Psychotropic drugs include the following types:

a) Containing one or more psychotropic drug substances or drugs containing psychotropic drug substances combined with precursor substances used in drugs as prescribed in Appendices II and III attached hereto.

b) Containing psychotropic drug substances (with or without narcotic drug substances, precursor substances used in drugs) combined with other drug substances that are not narcotic drug substances, psychotropic drug substances, or precursor substances used in drugs, where the concentration and quantity of psychotropic drug substances exceed the limits prescribed in Appendix V of this Circular, and the concentration and quantity of narcotic drug substances (if any) do not exceed the limits prescribed in Appendix IV attached hereto.

3. Precursor drugs include the following types:

a) Containing one or more precursor substances used in drugs as prescribed in Appendix III attached hereto;

b) Containing precursor substances used in drugs (with or without narcotic drug substances, psychotropic drug substances) combined with other drug substances that are not narcotic drug substances, psychotropic drug substances, or precursor substances used in drugs, where the concentration and quantity of precursor substances used in drugs exceed the limits prescribed in Appendix VI attached hereto, and the concentration and quantity of narcotic drug substances (if any) do not exceed the limits prescribed in Appendix IV attached hereto, and the concentration and quantity of psychotropic drug substances (if any) do not exceed the limits prescribed in Appendix V attached hereto.

4. Combined drugs containing narcotic drug substances include drugs meeting the following conditions simultaneously:

a) Containing narcotic drug substances; or narcotic drug substances combined with psychotropic drug substances, which may or may not contain precursor substances used in drugs, where the concentration and quantity of narcotic drug substances, psychotropic drug substances, and precursor substances used in drugs are all within the limits prescribed in Appendices IV, V, and VI attached hereto;

b) Containing other drug substances that are not narcotic drug substances, psychotropic drug substances, or precursor substances used in drugs.

5. Combined drugs containing psychotropic drug substances include drugs meeting the following conditions simultaneously:

a) Containing psychotropic drug substances or psychotropic drug substances combined with precursor substances used in drugs, where the concentration and quantity of psychotropic drug substances and precursor substances used in drugs are both within the limits prescribed in Appendices V and VI attached hereto;

b) Containing other drug substances that are not narcotic drug substances, psychotropic drug substances, or precursor substances used in drugs.

6. Combined drugs containing precursor substances include drugs meeting the following conditions simultaneously:

a) Containing precursor substances used in drugs, where the concentration and quantity of precursor substances used in drugs are within the limits prescribed in Appendix VI attached hereto;

b) Containing other drug substances that are not narcotic drug substances, psychotropic drug substances, or precursor substances used in drugs.

7. Drugs and drug substances listed in the list of drugs and drug substances prohibited for use in certain sectors and fields:

Medicines and pharmaceutical substances listed in the Catalogue of medicines and pharmaceutical substances included in the list of prohibited substances for use in certain sectors and fields shall be selected according to the principles stipulated in Clause 2, Article 41 of Decree No. 54/2017/ND-CP dated May 8, 2017 detailing some provisions and measures to implement the Medicine Law (hereinafter referred to as Decree No. 54/2017/ND-CP).

Chapter II

STORAGE, PRODUCTION, PREPARATION, DISTRIBUTION, USE, DISPOSAL,

HANDOVER, TRANSPORTATION, REPORTING ON MEDICINES AND RAW MATERIALS FOR MEDICINE MANUFACTURE MUST BE SUBJECT TO SPECIAL CONTROL

 Article 4. Storage

1. Medical examination and treatment facilities, compulsory drug rehabilitation centers, research and specialized training institutions in medicine, and other non-commercial pharmaceutical activity facilities must comply with the requirements of Good Storage Practices for medicines and raw materials for medicine manufacture, including:

a) Narcotic drugs, psychotropic drugs, precursor drugs, raw materials for medicine that are narcotic pharmaceutical substances, psychotropic pharmaceutical substances, and precursors used as drugs must be stored in separate locked warehouses or cabinets; if there are no separate warehouses or cabinets, narcotic drugs may be stored together with psychotropic drugs and precursor drugs in the same cabinet, shelf, or rack but must be arranged separately for each type of drug with clear labels to avoid confusion; Psychotropic drugs stored in village health stations' counters or cabinets must be securely locked and managed, distributed, and monitored by designated personnel;

b) Combined drugs containing narcotic pharmaceutical substances, combined drugs containing psychotropic pharmaceutical substances, and combined drugs containing precursors must be stored in separate areas and not mixed with other drugs;

c) Radioactive drugs must be stored in securely locked warehouses or cabinets ensuring radiation safety and security, and preventing environmental radiation exposure in accordance with relevant laws on atomic energy;

d) Toxic drugs and toxic raw materials for medicine must be stored in separate areas and not mixed with other drugs, must be neatly arranged to avoid confusion and easy observation within the storage area;

e) Narcotic drugs, psychotropic drugs, and precursors in emergency drug cabinets must be stored in separate compartments or drawers and not mixed with other drugs, and must be kept and distributed by nursing staff on duty based on medical orders. Emergency drug cabinets must be securely locked. The quantity and types of specially controlled drugs stored in emergency drug cabinets are determined in writing by the facility's head. When changing shifts, the drug keeper of the previous shift must hand over the quantity of drugs and the drug monitoring logbook to the drug keeper of the next shift. During handover, both parties must sign the drug monitoring logbook fully.

2. Drug managers must have appropriate qualifications corresponding to the type of specially controlled drugs and raw materials for medicine, specifically as follows:

a) For narcotic drugs and raw materials for medicine that are narcotic pharmaceutical substances, the manager at the hospital pharmacy department must hold a bachelor's degree in pharmacy or higher, while the manager at other facilities specified in Clause 2, Article 2 of this Circular must hold a diploma in pharmacy or higher;

b) For psychotropic drugs, precursors, and raw materials for medicine that are psychotropic pharmaceutical substances and precursors used as drugs, the manager must hold a diploma in pharmacy or higher;

c) In cases where village health stations lack personnel meeting the requirements of this clause, the facility's head must assign tasks in writing to personnel holding a certificate from a medical assistant level or higher;

d) For radioactive drugs, the manager must hold a diploma in pharmacy or higher or be a physician, technician, nurse, who has been trained in radiation safety and assigned tasks in writing by the facility's head.

c) For radioactive drugs, the manager must have a diploma in pharmacy or higher, or be a physician, technical officer, nurse who has received radiation safety training and been officially assigned duties in writing by the head of the facility.

Article 5. Production and Compounding

The production and compounding of special controlled drugs, including radioactive drugs, shall be carried out in accordance with the provisions set forth in Circular No. 22/2011/TT-BYT dated June 10, 2011, issued by the Minister of Health on the organization and operation of hospital pharmacy departments.

Article 6. Distribution, Use, and Disposal of Drugs

1. For healthcare facilities excluding drug substitution treatment facilities: the distribution and use of drugs shall be conducted in accordance with the provisions set forth in Circular No. 23/2011/TT-BYT dated June 10, 2011, issued by the Minister of Health guiding the use of drugs in healthcare facilities with beds (hereinafter referred to as Circular No. 23/2011/TT-BYT).

2. For compulsory detoxification centers and drug substitution treatment facilities: the distribution and use of special controlled drugs shall be carried out as follows:

a) The treatment department and general outpatient clinic shall issue a Narcotic Drug Withdrawal Prescription Form according to Model No. 1 attached to Circular No. 23/2011/TT-BYT for their own departments.

b) The pharmacy department shall distribute drugs to the treatment departments and outpatient clinics based on the Narcotic Drug Withdrawal Prescription Forms and must monitor and record the quantity of narcotics, psychotropic substances, and precursor chemicals in stock, input, and output in accordance with the model specified in Appendix VIII attached to this Circular.

c) In treatment departments and outpatient clinics, after receiving the drugs, the person assigned the task must verify the name, concentration, dosage, expiration date, and quantity of the drugs before administering or distributing them, providing instructions for use, and directly distributing them to patients.

d) Unused narcotics, psychotropic substances, and precursor chemicals, or those transferred by patients to other facilities or due to patient death, must be returned to the pharmacy department by the treatment department or outpatient clinic. The head of the pharmacy department must decide on reusing or destroying these substances according to regulations and prepare a record to be kept at the facility.

e) The head of the pharmacy department or a person holding a diploma in pharmacy or higher, appointed in writing by the facility's head, must approve the Narcotic Drug Withdrawal Prescription Forms of the treatment departments and outpatient clinics.

f) The head of the treatment department or deputy head of the treatment department, appointed in writing by the head of the treatment department, and the head of the outpatient clinic or deputy head of the outpatient clinic, appointed in writing by the head of the outpatient clinic, must approve the Narcotic Drug Withdrawal Prescription Forms for their respective departments.

3. Healthcare facilities, compulsory detoxification centers, specialized medical research and training institutions, and non-commercial pharmaceutical activity facilities must prepare a purchase application file in accordance with Article 53 of Decree No. 54/2017/NĐ-CP and submit it to the Department of Health where the facility is located for review and approval in accordance with Article 54 of Decree No. 54/2017/NĐ-CP before purchasing narcotics, psychotropic substances, precursors, and combined drugs containing precursors that are not subject to bidding for the needs of treatment, research, and testing at the facility.

4. Healthcare facilities, compulsory detoxification centers, specialized medical research and training institutions, and non-commercial pharmaceutical activity facilities may only dispose of narcotics, psychotropic substances, precursors, and raw materials for drugs that are narcotic substances, psychotropic substances, precursors used in drugs, and radioactive drugs after obtaining permission from the Department of Health where the facility is located in accordance with Article 48 of Decree No. 54/2017/NĐ-CP.

Article 7. Transfer and Transport Between Facilities

1. Requirements for facilities and persons transporting drugs and medicinal materials subject to special control:

a) Facilities participating in the transfer and receipt of radioactive drugs must have a radiation work permit, the scope of radioactive source transport, the person transferring, the person receiving, and the person transporting radioactive drugs must hold a radiation safety certificate in accordance with the regulations of the Ministry of Science and Technology;

b) Persons transporting narcotic drugs, psychotropic drugs, precursor drugs, and medicinal materials that are narcotic substances, psychotropic substances, and precursors used as drugs must carry a task assignment document from the facility's head, valid identification, sales invoices, or warehouse release forms when performing their duties.

2. Requirements for the transfer and transport of drugs and medicinal materials subject to special control:

a) When transferring and receiving narcotic drugs, psychotropic drugs, precursor drugs, and medicinal materials that are narcotic substances, psychotropic substances, and precursors used as drugs, there must be a transfer and receipt record according to the model specified in Appendix IX attached to this Circular;

b) When transferring and receiving drugs and medicinal materials subject to special control, the person transferring and the person receiving the drugs must conduct a visual inspection and verification of the drug name, material name, concentration, quantity, batch number, expiration date, and quality of the drugs and medicinal materials; they must sign and clearly write their full names on the warehouse release and receipt documents;

c) Narcotic drugs, psychotropic drugs, precursor drugs, and medicinal materials that are narcotic substances, psychotropic substances, and precursors used as drugs must ensure security during transportation to prevent loss.

Article 8. Reporting

1. Periodic Reports:

a) Before January 15 each year, medical examination and treatment facilities, compulsory drug rehabilitation centers, specialized medical research and training institutions, and other non-commercial pharmaceutical activity facilities shall prepare reports on the stock, usage, and inventory of narcotic drugs, psychotropic drugs, precursor drugs, radioactive drugs, and combined drugs containing precursors, and submit them to the Health Department where the facility is located according to the report form specified in Appendix X attached to this Circular;

b) Before February 15 each year: The Health Department shall report annually on the use of narcotic drugs, psychotropic drugs, precursor drugs, radioactive drugs, and combined drugs containing precursors within its jurisdiction, and the Military Medical Service of the Ministry of National Defense shall report annually on the use of narcotic drugs, psychotropic drugs, precursor drugs, radioactive drugs, and combined drugs containing precursors within its sector to the Ministry of Health according to the report form specified in Appendix XI attached to this Circular.

2. Ad hoc reports:

Within 48 (forty-eight) hours from the time of discovering errors or losses of radioactive drugs, narcotic drugs, psychotropic drugs, precursor drugs, combined drugs containing precursors, and medicinal materials that are narcotic substances, psychotropic substances, and precursors used as drugs, medical examination and treatment facilities, compulsory drug rehabilitation centers, specialized medical research and training institutions, and other non-commercial pharmaceutical activity facilities must prepare a written report and submit it to the Ministry of Health according to the report form specified in Appendix XII attached to this Circular.

3. Reports required under Clause 1 and 2 of this Article must be submitted online once the Ministry of Health implements a nationwide management software and data system.

Chapter III

SUPPLY OF RADIOACTIVE DRUGS

Article 9. Supply of radioactive drugs

Medical examination and treatment facilities that have been permitted to produce and compound may supply radioactive drugs to other medical examination and treatment facilities when meeting the following requirements:

1. The quantity of drugs produced and compounded for treatment purposes at the facility exceeds actual usage needs.

2. Written approval from the Ministry of Health (Department of Medicine - Ministry of Health).

Article 10. Documents for Requesting Supply of Radioactive Drugs

1. A request form for supplying radioactive drugs from the medical examination and treatment facility according to the prescribed form in Appendix XIII attached hereto.

2. Report on production, compounding, and use of the radioactive drugs proposed for supply at the medical examination and treatment facility producing and compounding, including specific information about machine capacity, production capability, quantity of drugs produced, number of patients using the drugs, quantity of drugs produced but not used with the seal of confirmation from the requesting facility according to the prescribed report form in Appendix XIV attached hereto.

Article 11. Procedures and Formalities for Permitting Supply of Radioactive Drugs

1. The medical examination and treatment facility submits one set of documents directly or through postal service to the Department of Medicine - Ministry of Health.

2. Upon receipt of the documents, the Department of Medicine - Ministry of Health issues to the requesting facility a Document Receipt Form according to the prescribed form in Appendix XV attached hereto.

3. Within fifteen days from the date recorded on the Document Receipt Form, if there is no requirement for modification or supplementation of the documents, the Department of Medicine - Ministry of Health issues a written approval for the supply of drugs by the facility; if there is a requirement for modification or supplementation of the documents, the Department of Medicine - Ministry of Health sends a written notice to the requesting facility specifying the required modifications or supplements.

4. After the facility submits modified and supplemented documents, the Department of Medicine - Ministry of Health issues to the facility a Document Receipt Form for Modified and Supplemented Documents according to the prescribed form in Appendix XV attached hereto.

a) If the modified and supplemented documents do not meet the requirements, the Department of Medicine - Ministry of Health issues a written notice to the facility according to Clause 3 of this Article;

b) If there is no requirement for modification or supplementation of the modified and supplemented documents, the Department of Medicine - Ministry of Health issues a written approval for the supply of drugs by the facility according to Clause 3 of this Article.

5. Within sixty days from the date the receiving agency issues a notice for modification or supplementation, the requesting facility must submit modified and supplemented documents as required. After this period, if the facility does not modify or supplement the documents or if the supplementary documents submitted ninety days after the initial submission do not meet the requirements, the submitted documents will lose their validity.

Chapter IV

DOCUMENTS, LEDGERS AND RETENTION OF EVIDENCE, DOCUMENTS

RELATED TO DRUGS, RAW MATERIALS FOR DRUGS

MUST BE SPECIALLY CONTROLLED

Article 12. Documents and Ledgers for Production Facilities

1. Production facilities producing narcotic drugs, psychotropic drugs, precursor drugs, raw materials for drugs which are narcotic substances, psychotropic substances, precursors used as drugs must establish and record in full the following types of ledgers:

a) Ledger for compounding and producing narcotic drugs, psychotropic drugs, precursor drugs according to the prescribed ledger form in Appendix XVI attached hereto;

b) Ledger for export, import, and inventory of narcotic drugs, psychotropic drugs, precursor drugs, raw materials for drugs which are narcotic substances, psychotropic substances, precursors used as drugs according to the prescribed ledger form in Appendix VIII attached hereto;

c) Export warehouse voucher for narcotic drugs, psychotropic drugs, precursor drugs, raw materials for drugs which are narcotic substances, psychotropic substances, precursors used as drugs according to the prescribed voucher form in Appendix XVII attached hereto;

d) Relevant documents related to the purchase and sale of narcotic drugs, psychotropic drugs, precursor drugs, raw materials for drugs which are narcotic substances, psychotropic substances, precursors used as drugs.

2. Production facilities producing combined drug formulations containing narcotic substances, combined drug formulations containing psychotropic substances, combined drug formulations containing precursors, toxic drugs, raw materials for toxic drugs, drugs and substances listed in the list of drugs and substances prohibited for use in certain industries and fields must record in full the following types of ledgers:

a) Ledger for export, import, and inventory of drugs according to the prescribed ledger form in Appendix XVIII attached hereto;

b) Export warehouse voucher for raw materials for drugs which are narcotic substances, psychotropic substances, precursors used as drugs according to the prescribed voucher form in Appendix XVII attached hereto;

c) Relevant documents related to the purchase and sale of raw materials for drugs which are narcotic substances, psychotropic substances, precursors used as drugs, combined drug formulations containing narcotic substances, combined drug formulations containing psychotropic substances, combined drug formulations containing precursors, toxic drugs, raw materials for toxic drugs, drugs and substances listed in the list of drugs and substances prohibited for use in certain industries and fields.

3. Production facilities producing radioactive drugs must establish and record in full the following types of ledgers:

a) Ledger for compounding and producing radioactive drugs according to the prescribed ledger form in Appendix XIX attached hereto;

b) Ledger for export, import, and inventory of radioactive drugs according to the prescribed ledger form in Appendix VIII attached hereto;

c) Export warehouse voucher for radioactive drugs according to the prescribed voucher form in Appendix XVII attached hereto;

d) Relevant documents related to the purchase and sale of radioactive drugs.

Article 13. Records and ledgers for export and import establishments

1. Export and import establishments dealing with narcotic drugs, psychotropic substances, precursor chemicals, raw materials for drug production which are narcotic substances, psychotropic substances, and precursors used in drug production must establish and record all types of records and ledgers as follows:

a) A ledger to track the export, import, and inventory of narcotic drugs, psychotropic substances, precursors, and raw materials for drug production which are narcotic substances, psychotropic substances, and precursors used in drug production, according to the model ledger specified in Appendix VIII attached to this Circular;

b) An export warehouse voucher for narcotic drugs, psychotropic substances, and precursors according to the model voucher specified in Appendix XVII attached to this Circular;

c) Documents related to the export, import, and sale of narcotic drugs, psychotropic substances, and precursors.

2. Export and import establishments dealing with combined drug formulations containing narcotic substances, combined drug formulations containing psychotropic substances, combined drug formulations containing precursors, toxic drugs, raw materials for toxic drug production, and drugs and substances listed in the Catalogue of Drugs and Substances Prohibited from Use in Certain Industries and Fields when tracking through records and ledgers must establish and record the following documents:

a) A ledger to track the export, import, and inventory of combined drug formulations containing narcotic substances, combined drug formulations containing psychotropic substances, combined drug formulations containing precursors, toxic drugs, raw materials for toxic drug production, and drugs and substances listed in the Catalogue of Drugs and Substances Prohibited from Use in Certain Industries and Fields, according to the model ledger specified in Appendix XVIII attached to this Circular;

b) Documents related to the export, import, and sale of combined drug formulations containing narcotic substances, combined drug formulations containing psychotropic substances, combined drug formulations containing precursors, toxic drugs, raw materials for toxic drug production, and drugs and substances listed in the Catalogue of Drugs and Substances Prohibited from Use in Certain Industries and Fields.

3. Export and import establishments dealing with radioactive drugs must establish and record the following documents:

a) A ledger to track the export, import, and inventory of radioactive drugs according to the model ledger specified in Appendix VIII attached to this Circular;

b) An export warehouse voucher for radioactive drugs according to the model voucher specified in Appendix XVII attached to this Circular;

c) Documents related to the export, import, and sale of radioactive drugs.

Article 14. Records and ledgers for wholesale establishments

1. Wholesale establishments dealing with narcotic drugs, psychotropic substances, and precursors must establish and record the following documents:

a) A ledger to track the export, import, and inventory of narcotic drugs, psychotropic substances, and precursors according to the model ledger specified in Appendix VIII attached to this Circular;

b) An export warehouse voucher for narcotic drugs, psychotropic substances, and precursors according to the model voucher specified in Appendix XVII attached to this Circular;

c) Documents related to the sale of narcotic drugs, psychotropic substances, and precursors.

2. Wholesale establishments dealing with combined drug formulations containing narcotic substances, combined drug formulations containing psychotropic substances, combined drug formulations containing precursors, toxic drugs, raw materials for toxic drug production, and drugs and substances listed in the Catalogue of Drugs and Substances Prohibited from Use in Certain Industries and Fields when tracking through records and ledgers must establish and record the following documents:

a) A ledger to track the export, import, and inventory of combined drug formulations containing narcotic substances, combined drug formulations containing psychotropic substances, combined drug formulations containing precursors, toxic drugs, raw materials for toxic drug production, and drugs and substances listed in the Catalogue of Drugs and Substances Prohibited from Use in Certain Industries and Fields, according to the model ledger specified in Appendix XVIII attached to this Circular;

b) Documents related to the sale of combined drug formulations containing narcotic substances, combined drug formulations containing psychotropic substances, combined drug formulations containing precursors, toxic drugs, raw materials for toxic drug production, and drugs and substances listed in the Catalogue of Drugs and Substances Prohibited from Use in Certain Industries and Fields.

3. Wholesale establishments dealing with radioactive drugs must establish and record the following tracking ledgers:

a) A ledger to track the export, import, and inventory of radioactive drugs according to the model ledger specified in Appendix VIII attached to this Circular;

b) An export warehouse voucher for radioactive drugs according to the model voucher specified in Appendix XVII attached to this Circular;

c) Documents related to the sale of radioactive drugs.

Article 15. Documents and ledgers for retail establishments

1. Retail pharmacies selling addictive drugs, psychotropic drugs, and precursor drugs must establish and record the following types of documents:

a) A ledger to track the export, import, and inventory of narcotic drugs, psychotropic substances, and precursors according to the model ledger specified in Appendix VIII attached to this Circular;

b) Outbound drug warehouse receipts for addictive drugs, psychotropic drugs, and precursor drugs from the supplier;

c) Prescriptions for addictive drugs and psychotropic drugs retained at the establishment after sale;

d) Receipt records for addictive drugs according to the model record specified in Appendix XX attached to this Circular;

đ) Customer information tracking ledger according to the model ledger specified in Appendix XXI attached to this Circular.

2. Retail establishments selling combined drug formulations containing addictive substances, combined drug formulations containing psychotropic substances, and combined drug formulations containing precursors must establish and record the customer information tracking ledger according to the model ledger specified in Appendix XXI attached to this Circular.

Article 16. Documents and ledgers for establishments providing drug storage services, clinical trial drug testing services, biological equivalence drug testing services, and drug testing services

1. Addictive drugs, psychotropic drugs, precursor drugs, raw materials for drugs that are addictive substances, psychotropic substances, and precursors used as drugs: must establish and record the following types of documents and ledgers:

a) A ledger to track the export, import, and inventory of narcotic drugs, psychotropic substances, precursors, and raw materials for drug production which are narcotic substances, psychotropic substances, and precursors used in drug production, according to the model ledger specified in Appendix VIII attached to this Circular;

b) Outbound drug warehouse receipts for addictive drugs, psychotropic drugs, and precursor drugs according to the model receipt specified in Appendix XVII attached to this Circular.

2. Combined drug formulations containing addictive substances, combined drug formulations containing psychotropic substances, combined drug formulations containing precursors; toxic drugs, toxic raw materials for drugs, drugs, and pharmaceutical substances listed in the Drug and Pharmaceutical Substance Catalogue prohibited for use in certain industries and fields must establish and record the drug inbound, outbound, and inventory tracking ledger according to the model ledger specified in Appendix XVIII attached to this Circular.

3. Radioactive drugs must establish and record the inbound, outbound, and inventory tracking ledger according to the model ledger specified in Appendix VIII attached to this Circular.

Article 17. Documents and ledgers for medical examination and treatment establishments, compulsory drug rehabilitation centers, specialized research and training establishments in medicine and pharmacy, and other non-commercial pharmaceutical activity establishments

1. Research and training establishments in medicine and pharmacy, other non-commercial pharmaceutical activity establishments, and medical examination and treatment establishments, except for establishments treating opiate addiction with substitute drugs, must establish and record the following types of ledgers:

a) Compounding ledger for addictive drugs, psychotropic drugs, precursor drugs, and radioactive drugs according to the model ledger specified in Appendices XVI and XIX attached to this Circular;

b) Inbound, outbound, and inventory tracking ledger for addictive drugs, psychotropic drugs, precursor drugs, raw materials for drugs that are addictive substances, psychotropic substances, and precursors used as drugs, and radioactive drugs according to the model ledger specified in Appendix VIII attached to this Circular.

2. Compulsory drug rehabilitation centers and establishments treating opiate addiction with substitute drugs must establish and record the ledgers as stipulated in point b, clause 1 of this Article.

Article 18. Retention of documents and ledgers

1. Pharmaceutical business establishments, medical examination and treatment establishments, compulsory drug rehabilitation centers, establishments treating opiate addiction with substitute drugs, specialized research and training establishments in medicine and pharmacy, and other non-commercial pharmaceutical activity establishments involved in activities related to controlled drugs and raw materials for drugs must retain relevant documents and materials concerning controlled drugs and raw materials for drugs in the form of documents, ledgers, or tracking software for a minimum period of two (02) years from the date the drugs and raw materials for drugs expire. Prescriptions for addictive drugs and psychotropic drugs shall be retained in accordance with Circular No. 05/2016/TT-BYT dated February 29, 2016, issued by the Minister of Health on prescription writing in outpatient treatment.

2. After the retention period, the head of the establishment shall convene a committee to destroy, prepare a destruction record, and retain the documents at the establishment.

Chapter V

IMPLEMENTING PROVISIONS

Article 19. Effective Date

1. This Circular takes effect from July 1, 2017.

2. Circular No. 19/2014/TT-BYT dated June 2, 2014, issued by the Minister of Health on the management of addictive drugs, psychotropic drugs, and precursor drugs used as drugs ceases to be effective from the date this Circular takes effect.

Article 20. Transitional Provisions

1. Current research and training establishments in medicine and pharmacy currently supplying radioactive drugs to medical examination and treatment establishments may continue to supply until the end of their contracts and no later than July 1, 2019. After this period, establishments wishing to continue supplying radioactive drugs must have a Certificate of Eligibility for Pharmaceutical Business Scope of Radioactive Drug Production as stipulated in Section 4 Chapter III of Decree No. 54/2017/NĐ-CP.

2. The tracking and management software system for the process of inbound, outbound, and inventory of controlled drugs of the establishments specified in Article 43 of Decree No. 54/2017/NĐ-CP must be connected online when the Ministry of Health implements the national unified management software and data system.

Article 21. Reference Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 22. Responsibility for enforcement

The Director of the Office of the Ministry, the Director of the Department of Medicine Management, the Heads of the Departments, the Directors of the Bureaus, the Director of the General Population Administration under the Ministry of Health, the Heads of the Ministries' subordinate agencies, the Provincial Health Service Directors, and the Heads of health agencies of relevant ministries and sectors are responsible for implementing this Circular.

During implementation, if there are any difficulties, please promptly report to the Ministry of Health (Department of Medicine Management - Ministry of Health) for study and resolution./.