Circular 27/2024/TT-BYT amend Circular 20/2017/TT-BYT drugs and drug materials under special control

CIRCULAR

Amending and supplementing a number of articles of
Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health on detailing a number of articles of the Law on Pharmacy and the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 concerning drugs and drug materials under special control

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Pursuant to the Law on Pharmacy dated April 06, 2016;

Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 detailing a number of articles of and providing measures for implementing the Law on Pharmacy;

Pursuant to the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 amending and supplementing a number of decrees on investment and business conditions under the Ministry of Health’s state management;

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

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

The Minister of Health promulgates the Circular amending and supplementing a number of articles of Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health on detailing a number of articles of the Law on Pharmacy and the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 concerning drugs and drug materials under special control.

Article 1. Amending and supplementing a number of articles of Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health on detailing a number of articles of the Law on Pharmacy and the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 concerning drugs and drug materials under special control

1. To amend and supplement Point d Clause 1 Article 1 as follows:

“d) List of drugs and pharmaceutical materials banned from use in a number of sectors and fields announced in the Minister of Health's Decision.”.

2. To amend and supplement Clause 7 Article 3 as follows:

“7. Drugs and pharmaceutical materials in the List of drugs and pharmaceutical materials banned from use in a number of sectors and fields:

Drugs and pharmaceutical materials in the List of drugs and pharmaceutical materials banned from use in a number of sectors and fields announced by the Ministry of Health in accordance with Clause 2 Article 41 of Decree No. 54/2017/ND-CP dated May 08, 2017 detailing a number of articles of and providing measures for implementing 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 amending and supplementing a number of decrees on investment and business conditions under the Ministry of Health’s state management (hereinafter referred to as Decree No. 155/2018/ND-CP).”.

3. To amend and supplement Clause 3 Article 6 as follows:

“3. A private medical examination and treatment establishment, research and assay establishment, medical and pharmacy training institution, compulsory detoxification establishment, establishment treating opium substance addiction with replacement drugs, or another establishment with pharmaceutical activities for non-commercial purposes must make a dossier of request for purchase of habit-forming drugs, psychotropic drugs, precursor drugs as defined 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 and send it to the provincial-level Department of Health of the locality where the establishment is headquartered or the Department of Military Medicine of the Ministry of National Defence for consideration and approval in accordance with Article 54 of Decree No. 54/2017/ND-CP and Clause 34 Article 5 of Decree No. 155/2018/ND-CP before purchase of habit-forming drugs, psychotropic drugs, precursor drugs.”.

4. To amend the title of Article 7 and add Point d after Point c Clause 2 Article 7 as follows:

a) To amend the title of Article 7 as follows:

“Article 7. Delivery and transport”.

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

“d) In case a drug retailing establishment receives habit-forming drugs, psychotropic drugs or precursor drugs upon the patients not using them up or dying, it must make 02 minutes on receipt of drugs, using the form defined in Appendix XX issued together with this Circular. Returned drugs must be stored in a secure area to prevent loss and must be destroyed in accordance with law regulations.”.

5. To amend and supplement Clause 1 Article 8 as follows:

“1. Periodic reports:

a) Before January 15 every year, medical examination and treatment establishments, research and assay establishments, medical and pharmacy training institutions, compulsory detoxification establishments, establishments treating opium substance addiction with replacement drugs, or other establishments with pharmaceutical activities for non-commercial purposes shall prepare reports on the output, input, inventory, and use of habit-forming drugs, psychotropic drugs, precursor drugs, radioactive drugs and combination drugs containing a precursor, made using the report form specified in Appendix X issued together with this Circular and send them to the following agencies:

- Department of Military Medicine of the Ministry of National Defence, for establishments under the Ministry of National Defence.

- Provincial-level Departments of Health of the localities where the establishments are headquartered.

b) Before February 15 every year: Provincial-level Departments of Health shall submit annual reports on use of habit-forming drugs, psychotropic drugs, precursor drugs, radioactive drugs and combination drugs containing a precursor of the establishments located in such localities, except for those under the Ministry of National Defence; the Department of Military Medicine of the Ministry of National Defence shall submit annual reports on use of habit-forming drugs, psychotropic drugs, precursor drugs, radioactive drugs and combination drugs containing a precursor of the branch’s establishments to the Ministry of Health, using the report form defined in Appendix XI issued together with this Circular.”.

6. To amend and supplement Clause 2 Article 9 as follows:

“2. Possess a written consent by the provincial-level Department of Health of the locality where the medical examination and treatment establishment providing radioactive drugs is located.”.

7. To amend and supplement Clause 1, Clause 2, Clause 3 and Clause 4 Article 11 as follows:

“1. A medical examination and treatment establishment providing radioactive drugs shall submit a dossier directly or by post or online (for cases where the dossier-receiving agency applies the online management software for such administrative procedure) to the provincial-level Department of Health of the locality where the establishment is located.

2. After receiving the dossier, the provincial-level Department of Health of the locality where the medical examination and treatment establishment providing radioactive drugs is located shall issue the requesting establishment a dossier receipt slip, made using the form specified in Appendix XV issued together with this Circular.

3. Within 15 days from the date recorded on the dossier receipt slip, if there is no request for amendment or supplementation of the dossier, the provincial-level Department of Health of the locality where the medical examination and treatment establishment providing radioactive drugs is located shall issue a written approval of the establishment’s drug supply; in case of request for amendment or supplementation of the dossier, of the locality where the medical examination and treatment establishment providing radioactive drugs is located shall send a written request to the establishment, specifically stating the documents and contents to be amended or supplemented.

4. After receiving the dossier, the provincial-level Department of Health of the locality where the medical examination and treatment establishment providing radioactive drugs is located shall issue the establishment a dossier receipt slip, made using the form specified in Appendix XV issued together with this Circular.

a) In case the amended and supplemented dossier does not meet the requirements, the provincial-level Department of Health of the locality where the medical examination and treatment establishment providing radioactive drugs is located shall notify the establishment in writing in accordance with Clause 3 of this Article;

b) In case of no request for amendment and supplementation of the amended and supplemented dossier, the provincial-level Department of Health of the locality where the medical examination and treatment establishment providing radioactive drugs is located shall issue a written approval of the establishment’s drug supply in accordance with Clause 3 of this Article.”.

8. To amend and supplement Point d Clause 1 Article 15 as follows:

“d) Minutes on receipt of habit-forming drugs, psychotropic drugs, precursor drugs, using the form of minutes defined in Appendix XX issued together with this Circular;”.

9. To amend Appendices X, XIII, XV and Appendix XX into the appendices issued together with this Circular.

Article 2. Repealing a number of contents of Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health on detailing a number of articles of the Law on Pharmacy and the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 concerning drugs and drug materials under special control

To repeal No. 7 of the List of appendices and repeal the Appendix VII issued together with the Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health on detailing a number of articles of the Law on Pharmacy and the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 concerning drugs and drug materials under special control.

Article 3. Effect

This Circular takes effect on January 30, 2025.

Article 4. Transitional provisions

1. Dossiers submitted before the effective date of this Circular shall continue to comply with the regulations at the time of dossier submission; except for cases where the requesting establishment carry out in accordance with this Circular.

2. Licenses to export or import drugs/ drug materials, orders for exported or imported drugs/ drug materials that are granted before the effective date of this Circular shall continue to be used until the expiration date of the license.

3. For drugs and drug materials for which a certificate of free sale in Vietnam is granted, drug materials announced in drug registration dossiers and which already have a certificate of free sale in Vietnam that are exported from the port of departure of the exporting country before the effective date of this Circular, the import shall comply with the List of drugs and pharmaceutical materials banned from use in a number of sectors and fields in the guiding document effective at the time the goods are exported from the port of departure of the exporting country.

Article 5. Implementation responsibility

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

Any problem arising in the course of implementation shall be promptly reported to the Ministry of Health (Drug Administration of Vietnam) for consideration and settlement./.

* All Appendices are not translated herein.