Circular 27/2024/TT-BYT amends Circular 20/2017/TT-BYT guiding the Drug Law and Decree 54/2017/NĐ-CP on special control drugs and drug precursors issued by the Minister of Health.

CIRCULAR

BASED ON THE PHARMACEUTICAL LAW dated April 6, 2016;

Pursuant to the Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures for implementing the Medicine Law;

Pursuant to the Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health;

Pursuant to Decree No. 95/2022/NĐ-CP dated November 15, 2022 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;

"d) List of drugs and pharmaceutical substances included in the list of prohibited substances for use in certain sectors and fields as published in the Decision of the Minister of Health."

"7. Drugs and pharmaceutical substances in the List of drugs and pharmaceutical substances included in the list of prohibited substances for use in certain sectors and fields:

The drugs and pharmaceutical substances in the List of drugs and pharmaceutical substances included in the list of prohibited substances for use in certain sectors and fields shall be announced by the Ministry of Health in accordance with Clause 2 Article 41 of Decree No. 54/2017/NĐ-CP dated May 8, 2017 detailing certain provisions and measures to implement the Drug Law (hereinafter referred to as Decree No. 54/2017/NĐ-CP) and Point b Clause 15 Article 5 of Decree No. 155/2018/NĐ-CP amending and supplementing certain regulations related to business conditions under the management of the Ministry of Health (hereinafter referred to as Decree No. 155/2018/NĐ-CP)."

"3. Private medical examination and treatment facilities, research and testing facilities, specialized training facilities in medicine and pharmacy, compulsory detoxification centers, opium substitute treatment centers, and other non-commercial drug activity facilities must prepare purchase application files in accordance with Article 53 of Decree No. 54/2017/NĐ-CP, Clause 23 Article 4 and Clause 33 Article 5 of Decree No. 155/2018/NĐ-CP and submit them to the Department of Health at the location where the facility is based or the Military Medical Department of the Ministry of National Defense for review and approval in accordance with Article 54 of Decree No. 54/2017/NĐ-CP and Clause 34 Article 5 of Decree No. 155/2018/NĐ-CP before purchasing narcotic drugs, psychotropic drugs, and precursor chemicals."

"7. Costs for implementing social assistance payment work for beneficiaries of social protection:

4. Amending the name of Article 7 and supplementing Point d after Point c Clause 2 Article 7 as follows:

"Article 7. Handover and transportation."

3. Amending and supplementing Clause 3 of Article 6 as follows:

b) Supplementing Point d after Point c Clause 2 Article 7 as follows:

"d) In cases where retail pharmacies receive back narcotic drugs, psychotropic drugs, and precursor chemicals from patients who have not used them up or have died, they must prepare a Receipt of Returned Medicines in two copies according to the model specified in Appendix XX attached to this Circular. Returned medicines must be stored separately in a secure area to prevent loss and destroyed in accordance with the relevant laws."

a) Amend the name of Article 7 as follows:

"1. Periodic reports:

a) Before January 15 each year, medical examination and treatment facilities, research and testing facilities, specialized training facilities in medicine and pharmacy, compulsory detoxification centers, opium substitute treatment centers, and other non-commercial drug activity facilities must prepare annual reports on the import, export, stock, and use of narcotic drugs, psychotropic drugs, precursor chemicals, radioactive drugs, and combined drugs containing precursors according to the report form specified in Appendix X attached to this Circular and submit them to the following agencies:

- Military Medical Department - Ministry of National Defense for facilities under the Ministry of National Defense.

5. Amend Clause 1 of Article 8 as follows:

- Department of Health at the location where the facility is based for facilities not falling under the above category.

b) Before February 15 each year: The Department of Health must report annually on the use of narcotic drugs, psychotropic drugs, precursor chemicals, radioactive drugs, and combined drugs containing precursors by the aforementioned facilities within its jurisdiction, excluding those under the Ministry of National Defense; the Military Medical Department - Ministry of National Defense must report annually on the use of narcotic drugs, psychotropic drugs, precursor chemicals, radioactive drugs, and combined drugs containing precursors by facilities under its jurisdiction to the Ministry of Health according to the report form specified in Appendix XI attached to this Circular."

6. Amending and supplementing Clause 2 Article 9 as follows:

"2. Approved in writing by the Department of Health at the location of the medical examination and treatment facility providing radioactive drugs."

7. Amending and supplementing Clause 1, Clause 2, Clause 3, and Clause 4 Article 11 as follows:

"1. Medical examination and treatment facilities providing radioactive drugs must submit one set of application documents directly, through postal service, or online (applicable if the receiving agency has implemented an online management software for this administrative procedure) to the Department of Health at the location of the facility.

2. After receiving the application documents, the Department of Health at the location of the medical examination and treatment facility providing radioactive drugs must issue a Receipt of Application Documents to the applicant according to the form specified in Appendix XV attached to this Circular.

3. Within 15 days from the date recorded on the Receipt of Application Documents, if there is no request for modification or supplementation of the application documents, the Department of Health at the location of the medical examination and treatment facility providing radioactive drugs must issue a written approval for the provision of drugs by the facility; if there is a request for modification or supplementation of the application documents, the Department of Health at the location of the medical examination and treatment facility providing radioactive drugs must send a written notice to the applicant specifying the required modifications or supplements.

4. After the facility submits modified or supplemented application documents, the Department of Health at the location of the medical examination and treatment facility providing radioactive drugs must issue a Receipt of Modified or Supplemented Application Documents to the applicant according to the form specified in Appendix XV attached to this Circular.

a) If the modified or supplemented application documents do not meet the requirements, the Department of Health at the location of the medical examination and treatment facility providing radioactive drugs must notify the facility according to the provisions of Clause 3 of this Article."

3. Within fifteen days from the date recorded on the Receipt Form, if there is no request for modification or supplementation of the dossier, the Department of Health where the medical facility providing radioactive drugs is located shall issue a written approval for the provision of drugs by the facility; in case of a request for modification or supplementation of the dossier, the Department of Health where the medical facility providing radioactive drugs is located shall send a written notice to the facility specifying the required documents and contents that need to be modified or supplemented.

4. After the facility submits the modified and supplemented dossier, the Department of Health where the medical facility providing radioactive drugs is located shall return to the facility the Receipt Form for the modified and supplemented dossier according to the form prescribed in Appendix XV attached to this Circular.

a) In case the modified and supplemented dossier does not meet the requirements, the Department of Health where the medical facility providing radioactive drugs is located shall notify the facility in accordance with Clause 3 of this Article.

b) In case there is no request for amendment or supplementation to the amendment and supplementation dossier, the Department of Health where the location of the medical facility providing radioactive drugs is situated shall issue a document approving the supply of drugs by such facility in accordance with Clause 3 of this Article.

8. Amend and supplement Point d of Clause 1 of Article 15 as follows:

"d) A record of returning narcotic drugs, psychotropic substances, and precursor chemicals according to the model record specified in Appendix XX attached hereto;"

9. Amend Appendices X, XIII, XV, and XX to become the appendices issued together with this Circular.

Article 2. Repeal certain contents of Circular No. 20/2017/TT-BYT dated May 10, 2017, of the Minister of Health detailing some provisions of the Drug Law and Decree No. 54/2017/NĐ-CP dated May 8, 2017, of the Government on special control drugs and drug raw materials.

Repeal item number 7 from the list of appendices and repeal Appendix VII promulgated by Circular No. 20/2017/TT-BYT dated May 10, 2017, of the Minister of Health detailing some provisions of the Drug Law and Decree No. 54/2017/NĐ-CP dated May 8, 2017, of the Government on special control drugs and drug raw materials.

Article 3. Effectiveness

This Circular takes effect from January 30, 2025.

Article 4. Transitional Provisions

1. Applications submitted before the date this Circular takes effect shall continue to be processed in accordance with the regulations at the time of submission of the application, except in cases where the entity requests processing in accordance with this Circular.

2. Export and import permits for drugs and drug raw materials, export and import orders for drugs and drug raw materials issued before the date this Circular takes effect shall continue to be valid until their expiration date.

3. Drugs and drug raw materials registered for circulation in Vietnam, and drug raw materials announced for production based on registration dossiers already registered for circulation in Vietnam, exported from the port of departure of the exporting country before the date this Circular takes effect, shall be subject to importation in accordance with the List of Drugs and Active Pharmaceutical Ingredients under the Prohibited Substances List for Certain Industries and Fields as provided in the guidance document effective at the time of export from the port of departure of the exporting country.

Article 5. Responsibilities for Implementation

The Director of the Office of the Ministry; the Director of the Drug Administration Bureau; the Inspector General of the Ministry; the Heads of units under and affiliated with the Ministry of Health; Directors of Provincial Health Departments; the Heads of health agencies of ministries, sectors, and related organizations are responsible for implementing this Circular.

During implementation, if difficulties or obstacles arise, please report them to the Ministry of Health (Drug Administration Bureau) for consideration and resolution.

 

ANNEX

AMENDMENTS AND SUPPLEMENTS TO THE FORMS ATTACHED TO CIRCULAR NO. 20/2017/TT-BYT
(Attached to Circular No. 27/2024/TT-BYT dated November 1, 2024, of the Minister of Health)

 

ANNEX X

MODEL REPORT ON EXPORTS, IMPORTS, STOCK, AND USAGE OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES, PRECURSOR CHEMICALS, RADIOACTIVE DRUGS, AND COMBINED DRUGS CONTAINING PRECURSORS

Name of Facility:...

No.:...

REPORT ON EXPORTS, IMPORTS, STOCK, AND USAGE OF NARCOTIC DRUGS, PSYCHOTROPIC SUBSTANCES, PRECURSOR CHEMICALS, RADIOACTIVE DRUGS, AND COMBINED DRUGS CONTAINING PRECURSORS

(From...to...)

Respectfully submitted to:...

 

* Quantity lost includes damage, breakage, expiration, etc., if any, must be reported in detail

** Legal representative or authorized person in charge, or deputy of the authorized legal representative

 

ANNEX XIII

MODEL APPLICATION FOR SUPPLY OF RADIOACTIVE DRUGS

 

APPLICATION FOR SUPPLY OF RADIOACTIVE DRUGS

Respectfully submitted to: Department of Health

I. General Information:

1. Name of Facility:...(1)...

2. Address:...(3)...

3. Name of Legal Representative/Authorized Person:

4. Telephone: ... Fax:...

5. Production Method: ...(4)...

II. Content of Request

Facility ...(1)...requests to be supplied with radioactive drugs produced by the facility for the medical facility ...(5)...Address ...(3)...to serve the treatment needs of patients at facility ...(5)..., specifically:

II. Documents Attached

1. Letter requesting supply of radioactive drugs from the medical facility needing to receive drugs for diagnosis and treatment of patients at the facility.

2. Approval document from the Ministry of Health allowing the facility to produce radioactive drugs.

3. Report on production and usage of the requested radioactive drugs at the supplying facility.

IV. Commitment of the Facility:

We hereby commit that all information and data provided in the application are entirely truthful. We will fully bear responsibility under the law if any violations occur.

We respectfully request the Department of Health ...(6)...to approve the supply of radioactive drugs.

Thank you very much./.

 

Remarks:

(1) Name of the requesting facility.

(2) Location of the requesting facility's medical service site.

(3) Address for postal delivery.

(4) Production method: cyclotron or nuclear reactor...

(5) Facility receiving radioactive drugs.

(6) Legal representative or authorized person in charge, or deputy of the authorized legal representative.

 

Appendix XV

MODEL RECEIPT FOR APPLICATION FOR SUPPLY OF RADIOACTIVE DRUGS

 

1. Declaring entity:

RADIATION DRUG SUPPLY APPLICATION FILE

1. Submitting entity: …

2. Address of submitting entity (in case of submission via postal service):

4. Number, date of document of the submitting entity (if applicable): …

List of documents⁽³⁾:………………………………………….

Note: This receipt only confirms that the entity has submitted the file to the receiving authority

 

Remarks:

(1) Receipt number

(2) Record for supplemental filing.

(3) Corresponding documents according to administrative procedures stipulated in this Circular (list in detail or attach a list).

 

Appendix XX

MODEL OF RECEIPT FOR THE RETURN OF ADDICTIVE DRUGS, STIMULANTS, AND PRECURSOR CHEMICALS

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

RECEIPT FOR THE RETURN OF ADDICTIVE DRUGS, STIMULANTS, AND PRECURSOR CHEMICALS

1. Name of person handing over:

- Address:

- Personal identification number/ Passport/ Other equivalent documents:

Issuing authority: Date of issue:

- Is a patient □                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       &

2. Name of retail establishment:

- Person responsible for pharmaceutical matters at the establishment:

- Address:

3. List of returned drugs:

4. Time of delivery/receipt: The items above will be delivered/received at...hours...minutes on...day...month...year

5. Delivery/receipt location (Specify the actual address for delivery/receipt):

This record is agreed upon and made in two copies, each party retains one copy.