Circular No. 27/2024/TT-BYT dated November 1, 2024 on amendments to Circular No. 20/2017/TT-BYT on elaboration of the Law on Pharmacy and Decree No. 54/2017/ND-CP on drugs and drug ingredients subject to special control

CIRCULAR

ON AMENDMENTS TO CIRCULAR NO. 20/2017/TT-BYT DATED MAY 10, 2017 OF THE MINISTER OF HEALTH ON ELABORATION OF THE LAW ON PHARMACY AND DECREE NO. 54/2017/ND-CP DATED MAY 8, 2017 OF THE GOVERNMENT ON DRUGS AND DRUG INGREDIENTS SUBJECT TO SPECIAL CONTROL

Pursuant to the Law on Pharmacy dated April 6, 2016;

Pursuant to Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government on elaboration of and measures for implementation of the Law on Pharmacy;

Pursuant to Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government on amendments to several regulations on investment and business conditions under the state management of the Ministry of Health;

Pursuant to Decree No. 95/2022/ND-CP dated November 15, 2022 of the Government on the functions, duties, powers, and organizational structure of the Ministry of Health;

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

The Minister of Health hereby issues this Circular on amendments to Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health on elaboration of the Law on Pharmacy and Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government on drugs and drug ingredients subject to special control.

Article 1. Amendments to certain articles of Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health on elaboration of the Law on Pharmacy and Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government on drugs and drug ingredients subject to special control

1. Amendments to point dd clause 1 Article 1 as follows:

“dd) List of drugs and pharmaceutical substances included in the list of substances prohibited for use in certain industries and sectors, as announced by the Minister of Health.”

2. Amendment to clause 7 Article 3:

“7. Drugs and pharmaceutical substances in the list of substances prohibited for use in certain industries and sectors:

Drugs and pharmaceutical substances included in the list of substances prohibited for use in certain industries and sectors are announced by the Ministry of Health in accordance with clause 2 Article 41 of Decree No. 54/2017/ND-CP dated May 8, 2017, on elaboration of and measures for implementation of the Law on Pharmacy (hereinafter referred to as Decree No. 54/2017/ND-CP), and point b clause 15 Article 5 of Decree No. 155/2018/ND-CP on amendments to and supplementation of several regulations on investment and business conditions under the state management of the Ministry of Health (hereinafter referred to as Decree No. 155/2018/ND-CP).”

3. Amendment to clause 3 Article 6:

“3. Private medical treatment facilities, research and testing institutions, medical and pharmaceutical training institutions, compulsory detoxification establishments, facilities for opioid substitution therapy, and other non-commercial pharmaceutical operations must prepare an application for the purchase of drugs as prescribed in Article 53 of Decree No. 54/2017/ND-CP , clause 23 Article 4, and clause 33 Article 5 of Decree No. 155/2018/ND-CP. This application must be submitted to the Department of Health where the facility is located or the Military Medical Department of the Ministry of National Defense for review and approval according to Article 54 of Decree No. 54/2017/ND-CP and clause 34 Article 5 of Decree No. 155/2018/ND-CP before purchasing narcotic drugs, psychotropic drugs, and precursors.”.

4. Amendments to the title of Article 7 and supplement point dd after point c clause 2 Article 7 as follows:

a) Amendment to the title of Article 7 as follows:

“Article 7. Delivery and transportation.”

b) Supplement point dd after point c clause 2 Article 7 as follows:

“dd) In cases where retail drug establishments receive narcotic drugs, psychotropic drugs, or precursors returned by patients who have not fully used them or due to their death, a Drug Return Record must be prepared in 02 copies, following the template specified in Appendix XX enclosed with this Circular. Returned drugs must be securely stored in an area ensuring security against loss and disposed of in accordance with legal regulations.”

5. Amendments to clause 1 Article 8:

“1. Periodic reports:

a) By January 15 each year, medical treatment facilities, research and testing institutions, medical and pharmaceutical training institutions, compulsory detoxification establishments, facilities for opioid substitution therapy, and other non-commercial pharmaceutical operations must prepare reports on import, export, inventory, and use of narcotic drugs, psychotropic drugs, precursors, radiopharmaceuticals, and combination drugs containing precursors. Reports must follow the template specified in Appendix X enclosed with this Circular and be submitted to the following authorities:

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

- The Department of Health where the facility is located for facilities not under the above category.

b) By February 15 each year, the Department of Health must report the annual use of narcotic drugs, psychotropic drugs, precursors, radiopharmaceuticals, and combination drugs containing precursors by facilities in its jurisdiction, excluding facilities under the Ministry of National Defense. The Military Medical Department of the Ministry of National Defense must report the annual use of such drugs by its facilities to the Ministry of Health, using the report template specified in Appendix XI enclosed with this Circular.”.

6. Amendments to clause 2 Article 9:

“2. Written approval must be obtained from the Department of Health where the medical treatment facility providing radiopharmaceuticals is located.”.

7. Amendments to clauses 1, 2, 3, and 4 of Article 11 as follows:

“1. Medical treatment facilities providing radiopharmaceuticals must submit one set of documents directly, by post, or online (applicable where the receiving authority has implemented online management software for this administrative procedure) to the Department of Health where the facility is located.

2. Upon receiving the documents, the Department of Health where the medical treatment facility providing radiopharmaceuticals is located shall issue a Receipt of Application Form to the applicant, following the template provided in Appendix XV enclosed with this Circular.

3. Within 15 days from the date recorded on the Receipt of Application Form, if there are no requirements for amendments to the documentation, the Department of Health where the facility is located shall issue written approval for the facility to provide radiopharmaceuticals. If amendment documentation is the Department of Health shall send a written request to the applicant, specifying the documents and content that need to be amended or supplemented.

4. After the applicant submits the amendment documentation, the Department of Health where the facility is located shall issue a Receipt of Amendment Documentation to the applicant, following the template provided in Appendix XV enclosed with this Circular.

a) If the amendment documentation do not meet the requirements, the Department of Health where the medical treatment facility providing radiopharmaceuticals is located shall issue a written notification to the facility as stipulated in clause 3 of this Article;

b) If no amendments or additional requirements are needed for the amendment documentation, the Department of Health where the medical treatment facility providing radiopharmaceuticals is located shall issue a written approval for the facility to provide radiopharmaceuticals as stipulated in clause 3 of this Article.”.

8. Amendments to point dd clause 1 Article 15 as follows:

“dd) Receipt of narcotic drugs, psychotropic substances, or precursors, as per the receipt template provided in Appendix XX enclosed with this Circular;”.

9. Amendments to Appendices X, XIII, XV, and Appendix XX as attached to this Circular.

Article 2. Annulment of certain provisions of Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health on elaboration of the Law on Pharmacy and Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government on drugs and drug ingredients under special control

The following are annulled: Item 7 under the list of appendices; Appendix VII issued with Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health on elaboration of the Law on Pharmacy and Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government on drugs and drug ingredients under special control.

Article 3. Entry into force

This Circular comes into force as of January 30, 2025.

Article 4. Transitional provisions

1. Applications submitted prior to the effective date of this Circular shall continue to be processed under the regulations applicable at the time of submission, except where the applicant opts to comply with the provisions of this Circular.

2. Export and import permits for drugs and drug ingredients, as well as export and import orders for drugs and drug ingredients issued prior to the effective date of this Circular, shall remain valid until the expiration of their validity period.

3. Drugs and drug ingredients that have been granted marketing authorization in Vietnam or drug ingredients announced for drug production as per registered drug dossiers with valid marketing authorizations in Vietnam, which were shipped from the port of departure of the exporting country before the effective date of this Circular, shall be subject to the list of prohibited substances in specific industries or fields as per the guidance documents effective at the time the goods were shipped from the port of departure of the exporting country.

Article 5. Responsibilities for implementation

The Chief of the Office of the Ministry; the Director of the Drug Administration of Vietnam; the Chief Inspector of the Ministry; the heads of units under and affiliated with the Ministry of Health; the Directors of Health Departments of provinces and centrally-affiliated cities; the heads of health agencies of ministries and sectors; and relevant agencies, organizations, and individuals shall implement this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Drug Administration of Vietnam) for review and resolution./.