Circular No. 39/2025/TT-BYT stipulates the分级实施任务和办理行政手续的规定，属于卫生部权限的药品领域。

CIRCULAR

Regulations on the delegation of implementation of certain tasks and resolution of certain administrative procedures in the pharmaceutical sector within the authority of the Ministry of HealthIn accordance with the Medicine Law dated April 6, 2016; the Law amending and supplementing certain articles of the Medicine Law dated November 21, 2024;

Pursuant to the Government Organization Law on February 18, 2025;

Pursuant to Decree No. 163/2025/NĐ-CP dated June 29, 2025 of the Government detailing certain provisions and measures for organizing and guiding the implementation of the Medicine Law;

Pursuant to Decree No. 217/2025/NĐ-CP dated August 5, 2025 of the Government on specialized inspection activities;

Pursuant to Decree No. 105/2021/NĐ-CP dated December 4, 2021 of the Government detailing and guiding the implementation of certain provisions of the Law on Prevention and Control of Narcotics;

At the proposal of the Director of the Drug Administration and the Director of the Traditional Medicine Administration;

Pursuant to Decree No. 42/2025/NĐ-CP dated February 27, 2025 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

The Minister of Health issues this Circular regulating the delegation of implementation of certain tasks and resolution of certain administrative procedures in the pharmaceutical sector within the authority of the Ministry of Health.

This Circular regulates the delegation of implementation of certain tasks and resolution of certain administrative procedures in the pharmaceutical sector within the authority of the Ministry of Health.

Article 1. Scope of Regulation

Article 2. Delegation of implementation of certain tasks and resolution of certain administrative procedures in the pharmaceutical sector within the authority of the Ministry of Health to the Drug Administration

1. Implementation of certain tasks assigned to the Ministry of Health under Decree No. 163/2025/NĐ-CP dated June 29, 2025 of the Government detailing certain provisions and measures for organizing and guiding the implementation of the Medicine Law (hereinafter referred to as Decree No. 163/2025/NĐ-CP), Decree No. 217/2025/NĐ-CP dated August 5, 2025 of the Government on specialized inspection activities (hereinafter referred to as Decree No. 217/2025/NĐ-CP), Decree No. 105/2021/NĐ-CP dated December 4, 2021 of the Government detailing and guiding the implementation of certain provisions of the Law on Prevention and Control of Narcotics (hereinafter referred to as Decree No. 105/2021/NĐ-CP) and Decree No. 42/2025/NĐ-CP dated February 27, 2025 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health (hereinafter referred to as Decree No. 42/2025/NĐ-CP), including:

a) Proposing the wholesale price level for drugs that have been announced or re-announced, for prescription chemical drugs, herbal drugs, vaccines, and biological products during their circulation on the market according to Articles 116, 117, 118, and 119 of Decree No. 163/2025/NĐ-CP;

b) Concluding that raw materials for drugs, which are chemical products, vaccines, and biological products, fall into cases requiring recall, issuing decisions to recall raw materials for drugs in compulsory recall situations, and other management activities under the responsibility of the Ministry of Health regarding recalled raw materials for drugs according to point a, clause 1, point a, and point đ, clause 2, Article 100, and clause 4, Article 101 of Decree No. 163/2025/NĐ-CP;

c) Performing specialized inspection tasks on organizations and individuals engaged in drug production, testing, export, import, storage, transportation, pharmacy chain organization, wholesale, retail, purchase, sale, transfer, use of drugs and raw materials for drugs; biological equivalence testing of drugs; drug information and advertising according to clause 1, Article 6 of Decree No. 217/2025/NĐ-CP;

d) Amending and adjusting the content of drug advertisements that have been confirmed for chemical drugs, herbal drugs, and biological products according to Article 109 of Decree No. 163/2025/NĐ-CP;

đ) Receiving reports from facilities and units sent to the Ministry of Health according to Articles 35 and 81 of Decree No. 163/2025/NĐ-CP;

e) Receiving applications, organizing reviews and evaluations, and submitting to the Minister of Health for issuance, change, adjustment of content, and revocation of certificates of eligibility to operate in the pharmaceutical sector for production, export, and import facilities of drugs and raw materials for drugs; facilities providing drug storage services; facilities providing drug testing services; facilities providing biological equivalence testing services of drugs; facilities organizing pharmacy chains; facilities producing pharmaceutical packaging; in accordance with the law and international practices; coordinating with the Office of the Ministry to publish the list of pharmaceutical business facilities granted, renewed, adjusted, or revoked certificates of eligibility to operate on the Ministry of Health's electronic portal according to Articles 21, 22, and 23 of Decree No. 163/2025/NĐ-CP;

g) Receiving applications, organizing reviews and evaluations, and submitting to the Minister of Health for issuance and revocation of drug practice certificates through examinations according to the law and international practices; coordinating with the Office of the Ministry to publish the list of individuals granted or revoked drug practice certificates through examinations on the Ministry of Health's electronic portal according to Articles 5 and 7 of Decree No. 163/2025/NĐ-CP;

h) Receiving reports and notifications from agencies and organizations, compiling, and coordinating with the Office of the Ministry to publish on the Ministry of Health's electronic portal: Decisions to revoke drug practice certificates issued by granting agencies and revoked drug practice certificates; Decisions to revoke certificates of eligibility to operate in the pharmaceutical sector issued by granting agencies and revoked certificates of eligibility to operate in the pharmaceutical sector; Information related to imported drugs according to the law; Lists of foreign entities supplying drugs and raw materials for drugs to Vietnam proposed for publication by competent authorities of exporting countries according to Article 7, Article 23, clause 7, Article 62, and Article 79 of Decree No. 163/2025/NĐ-CP;

h) Receive reports and Notifications from agencies and organizations, compile and coordinate with the Ministry's Office to implement posting and publication on the Ministry of Health’s electronic portal: Decisions revoking pharmaceutical practice certificates issued by competent authorities and the revocation of such certificates; Decisions revoking certificates of eligibility for pharmaceutical business operations issued by competent authorities and the revocation of such certificates; Information related to imported drugs as prescribed by law; Lists of foreign establishments supplying drugs and drug raw materials to Vietnam proposed for publication by the competent authority of the exporting country pursuant to Article 7, Article 23, Clause 7 of Article 62, and Article 79 of Decree No. 163/2025/NĐ-CP;

i) Compile the situation of lawful activities related to drugs in the pharmaceutical sector and submit regular reports, exchange information, forecast import and export needs for narcotic drugs, psychotropic substances, precursor chemicals, raw materials for narcotic drugs, psychotropic substances, and precursors used in drug production, in accordance with the provisions of the law; guide and inspect local competent authorities to conduct control over the storage, sale, distribution, use, disposal, and exchange of narcotic drugs, psychotropic substances, precursors, and raw materials for narcotic drugs, psychotropic substances, and precursors used in drug production by entities engaged in production, import, export, temporary import for re-export, temporary export for re-import, in accordance with Clause 1 Article 33, Clause 2 Article 34, Article 35, and Article 36 of Decree No. 105/2021/NĐ-CP.

k) Issue, extend, adjust, change, supplement, and revoke certificates for drug products in accordance with Point c Clause 11 Article 2 of Decree No. 42/2025/NĐ-CP.

2. Grant permission to import raw materials for controlled drugs (procedure code 1.014071) for raw materials that are narcotic drug substances, psychotropic drug substances, precursors used in drug production, radioactive substances, drug substances listed in the drug catalog, drug substances included in the list of prohibited substances for certain industries and fields, toxic raw materials for drug production except for toxic herbal medicines, in accordance with Article 67 of Decree No. 163/2025/NĐ-CP.

3. Grant permission to import drugs not registered for circulation in Vietnam containing drug substances not registered for circulation in Vietnam, drugs containing herbal medicines used for the first time in Vietnam (procedure code 1.014072) for chemical drugs, herbal medicines, vaccines, and biological products, in accordance with Clause 2 Article 62 of Decree No. 163/2025/NĐ-CP.

4. Grant permission to import rare drugs not registered for circulation in Vietnam containing drug substances already registered for circulation in Vietnam but not meeting sufficient treatment needs, drugs containing herbal medicines previously used in Vietnam but not meeting sufficient treatment needs (procedure code 1.014073) for chemical drugs, herbal medicines, vaccines, and biological products, in accordance with Clause 2 Article 62 of Decree No. 163/2025/NĐ-CP.

5. Grant permission to import rare drugs not registered for circulation in Vietnam (procedure code 1.014074) for chemical drugs, herbal medicines, vaccines, and biological products, in accordance with Clause 2 Article 62 of Decree No. 163/2025/NĐ-CP.

6. Permit the purchase of raw materials for controlled drugs, which are narcotic drug substances, psychotropic drug substances, and precursors used in drug production (procedure code 1.014077), in accordance with Point a Clause 1 and Clause 2, Clause 3, Clause 4, Clause 5 of Article 39 of Decree No. 163/2025/NĐ-CP.

7. Permit the transfer of raw materials for controlled drugs, which are narcotic drug substances, psychotropic drug substances, and precursors used in drug production (procedure code 1.014080), in accordance with Point a Clause 1 and Clause 2, Clause 3, Clause 4, Clause 5 of Article 39 of Decree No. 163/2025/NĐ-CP.

8. Grant permission to import drugs not registered for circulation in Vietnam to meet special treatment needs (procedure code 1.014082) for chemical drugs, herbal medicines, vaccines, and biological products, in accordance with Clause 5 Article 62 of Decree No. 163/2025/NĐ-CP.

9. Grant permission to import drugs not registered for circulation in Vietnam having the same trade name, active ingredient, dosage form, or concentration as the original drug registered for circulation in Vietnam, produced by the original drug manufacturer or by an authorized manufacturer, at a lower price than the original drug circulating in Vietnam (procedure code 1.014083) for chemical drugs, herbal medicines, vaccines, and biological products, in accordance with Clause 5 Article 62 of Decree No. 163/2025/NĐ-CP.

10. Grant permission to import drugs not registered for circulation in Vietnam to meet urgent needs for national defense, security, epidemic prevention, disaster relief (procedure code 1.014091) for chemical drugs, herbal medicines, vaccines, and biological products, in accordance with Clause 3 and Clause 4 Article 62 of Decree No. 163/2025/NĐ-CP, excluding the issuance of decisions approving drugs for urgent needs in epidemic prevention, disaster relief, and consideration and decision-making for cases specified in Point e Clause 3 and Point e Clause 4 Article 62 of Decree No. 163/2025/NĐ-CP.

For cases specified in Point e Clause 3 and Point e Clause 4 Article 62 of Decree No. 163/2025/NĐ-CP, the Drug Administration Department shall report to the Minister of Health for consideration and decision on granting import permits and implement such permits after receiving the Minister's approval.

11. Issue confirmation certificates for drug advertising content (excluding advertising through organizing seminars, conferences, and drug introduction events) (procedure code 1.014093) for chemical drugs, herbal medicines, and biological products, in accordance with Clause 1, Clause 2, Clause 3, Clause 4, Clause 6, Clause 7, Clause 8 of Article 108 of Decree No. 163/2025/NĐ-CP.

12. Issue confirmation certificates for drug advertising content through organizing seminars, conferences, and drug introduction events (procedure code 1.014095) for chemical drugs, herbal medicines, and biological products, in accordance with Clause 1, Clause 2, Clause 3, Clause 4, Clause 6, Clause 7, Clause 8 of Article 108 of Decree No. 163/2025/NĐ-CP.

13. Grant permission to import drug substances, semi-finished drug products, herbal medicines, and semi-finished herbal medicine products for producing drugs to serve national defense and security requirements, to meet the needs of preventing and treating infectious diseases classified as Group A under the law on prevention and control of infectious diseases, to address consequences of accidents, natural disasters, and catastrophes, excluding specially controlled raw materials (procedure code 1.014096) for drug substances, semi-finished drug products, and semi-finished herbal medicine products, in accordance with Clause 2 Article 73 of Decree No. 163/2025/NĐ-CP.

14. Decision to permit the change of purpose for the use of pharmaceutical substances and medicinal materials for the production of drugs that have been granted registration certificates for circulation with indications for the prevention and treatment of infectious diseases belonging to Group A that have been declared under the law on prevention and control of infectious diseases, for pharmaceutical substances and medicinal materials that have been permitted for importation for other purposes (TTHC code 1.014098), as provided for in Article 84 of Decree No. 163/2025/NĐ-CP.

15. Granting permission for the export of drugs and raw materials for drugs that are allowed to be exported without a permit from the Ministry of Health as stipulated in Clause 5, Article 60 of the Medicine Law, when the entity has a need for an export permit (TTHC code 1.014097), as provided for in Point b, Clause 5, Article 82 of Decree No. 163/2025/NĐ-CP.

16. Granting permission for the importation of drugs not yet registered for circulation in Vietnam for display at exhibitions and trade fairs (TTHC code 1.014106), as provided for in Clause 5, Article 62 of Decree No. 163/2025/NĐ-CP, for chemical drugs, herbal drugs, vaccines, and biological products.

17. Granting permission for the importation of pharmaceutical substances, drug intermediates, medicinal materials, medicinal material intermediates, excipients, and capsules for testing, research, and compounding of drugs at healthcare facilities, excluding special controlled raw materials (TTHC code 1.014107), as provided for in Clause 1, Article 73 of Decree No. 163/2025/NĐ-CP.

18. Granting permission for the importation of pharmaceutical substances, drug intermediates, medicinal materials, medicinal material intermediates, excipients, and capsules for the production of drugs for export, excluding special controlled raw materials (TTHC code 1.014108), as provided for in Clause 1, Article 73 of Decree No. 163/2025/NĐ-CP.

19. Granting permission for the export of narcotic drugs, psychotropic drugs, precursor drugs, combined drugs containing narcotic substances, combined drugs containing psychotropic substances, combined drugs containing precursors, raw materials for drugs being narcotic substances, psychotropic substances, and precursors used as drugs (TTHC code 1.014109), as provided for in Clause 1, Article 49 of Decree No. 163/2025/NĐ-CP.

20. Granting permission for the export of narcotic drugs, psychotropic drugs, precursor drugs, narcotic substances, psychotropic substances, precursors used as drugs, combined drugs containing narcotic substances, combined drugs containing psychotropic substances, combined drugs containing precursors for participation in displays at exhibitions and trade fairs (TTHC code 1.014110), as provided for in Clause 1, Article 49 of Decree No. 163/2025/NĐ-CP.

21. Granting permission for the importation of specially controlled drugs with registration certificates for circulation in Vietnam (TTHC code 1.014079), as provided for in Article 67 of Decree No. 163/2025/NĐ-CP, for narcotic drugs, psychotropic drugs, precursor drugs, combined drugs containing narcotic substances, combined drugs containing psychotropic substances, combined drugs containing precursors, radioactive drugs; drugs and pharmaceutical substances listed in the list of prohibited substances for use in certain industries and fields; toxic drugs; raw materials for drugs that are toxic.

22. Granting permission for the export of radioactive drugs; raw materials for drugs that are radioactive substances; drugs and pharmaceutical substances listed in the list of prohibited substances for use in certain industries and fields; toxic drugs; raw materials for drugs that are toxic (TTHC code 1.014081), as provided for in Clause 1, Article 49 of Decree No. 163/2025/NĐ-CP.

23. Granting permission for the importation of drugs not yet registered for circulation in Vietnam for aid and humanitarian assistance (TTHC code 1.014086), as provided for in Points a, b, c, d, đ, e, and h, Clauses 2 and 5, Article 62 of Decree No. 163/2025/NĐ-CP, for chemical drugs, herbal drugs, vaccines, and biological products.

The Drug Administration Department reports to the Minister of Health for consideration of granting import permits for drugs based on the advice of the advisory council responsible for advising on drug import permits and the commitment of the entity providing the drug aid regarding the drug having been approved for circulation in the country of manufacture or a member of the ICH or Australia, and the commitment of the recipient entity regarding the responsibility for the safety and efficacy of the drug, as provided for in Point g, Clause 2, Article 62 of Decree No. 163/2025/NĐ-CP, and implements the issuance of the permit after receiving the approval of the Minister of Health.

24. Granting permission for the export of specially controlled drugs that have been imported for charitable medical activities but not fully utilized (TTHC code 1.014094), as provided for in Clause 1, Article 49 of Decree No. 163/2025/NĐ-CP, for chemical drugs, herbal drugs, vaccines, and biological products.

25. Granting permission for the export of narcotic drugs, psychotropic drugs, precursor drugs, combined drugs containing narcotic substances, combined drugs containing psychotropic substances, combined drugs containing precursors, narcotic substances, psychotropic substances, and precursors used as drugs for clinical trials, bioequivalence testing, bioavailability assessment, sample testing, scientific research, and registration samples (TTHC code 1.014112), as provided for in Clause 1, Article 49 of Decree No. 163/2025/NĐ-CP.

26. Granting export permits for radioactive drugs, raw materials for drugs that are radioactive substances; toxic drugs, raw materials for toxic drugs, drugs and pharmaceutical ingredients listed in the list of drugs and pharmaceutical ingredients prohibited from use in certain industries and fields for clinical trials, bioequivalence testing, bioavailability assessment, sample testing, scientific research, registration samples (procedure code TTHC 1.014114) for radioactive drugs, raw materials for drugs that are radioactive substances; toxic drugs except traditional toxic medicines, toxic chemical raw materials for drugs, drugs and pharmaceutical ingredients listed in the list of drugs and pharmaceutical ingredients prohibited from use in certain industries and fields as stipulated in Clause 1, Article 49 of Decree No. 163/2025/NĐ-CP.

27. Granting import permits for drugs without a circulation registration certificate in Vietnam for clinical trials, bioequivalence testing, bioavailability assessment, sample testing, scientific research purposes (procedure code TTHC 1.014115) for chemical drugs, herbal drugs, vaccines, and biological products as stipulated in Points a, b, c, d, đ, e of Clause 5, Article 62 of Decree No. 163/2025/NĐ-CP.

28. Granting export permits for medicinal herbs belonging to the list of precious, rare, endemic medicinal herb species requiring control (procedure code TTHC 1.014120) for semi-finished medicinal herbs as stipulated in Clause 1, Article 49 of Decree No. 163/2025/NĐ-CP.

29. Granting import permits for medicinal herbs not falling under the provisions of Articles 68, 69, 70, and 71 of Decree No. 163/2025/NĐ-CP dated June 29, 2025 of the Government, except for raw materials for drugs requiring special control (procedure code TTHC 1.014122) for semi-finished medicinal herbs as stipulated in Clause 1, Article 73 of Decree No. 163/2025/NĐ-CP.

30. Granting export permits for specially controlled drugs for aid, humanitarian aid (procedure code TTHC 1.014124) for narcotic drugs, psychotropic drugs, precursor drugs, combined drugs containing narcotic substances, combined drugs containing psychotropic substances, combined drugs containing precursors, radioactive drugs; drugs listed in the list of drugs and pharmaceutical ingredients prohibited from use in certain industries and fields; toxic drugs except traditional toxic medicines as stipulated in Clause 1, Article 49 of Decree No. 163/2025/NĐ-CP.

31. Announcing, re-announcing wholesale prices for prescription drugs (procedure code TTHC 1.014118) which are chemical drugs, herbal drugs, vaccines, biological products as stipulated in Article 114 of Decree No. 163/2025/NĐ-CP.

32. Granting export and import permits for drugs, raw materials for drugs, direct contact drug packaging materials, confirming information content of drugs; confirming advertising content of drugs; approving orders for purchasing narcotic drugs, psychotropic drugs, precursor drugs, raw materials for drugs that are narcotic substances, psychotropic substances, precursors used as drugs for administrative procedures according to the provisions of Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some articles and measures to implement the Law on Medicines, Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing some relevant regulations concerning investment and business conditions within the scope of management of the Ministry of Health, and Decree No. 88/2023/NĐ-CP dated December 11, 2023 of the Government amending and supplementing some articles of Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some articles and measures to implement the Law on Medicines and Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing some relevant regulations concerning investment and business conditions within the scope of management of the Ministry of Health submitted before July 1, 2025 and being processed according to Clause 1, Article 127 of Decree No. 163/2025/NĐ-CP, except where the entity requests implementation according to Law No. 44/2024/QH15 amending and supplementing some articles of the Law on Medicines No. 105/2016/QH13 or the provisions of Decree No. 163/2025/NĐ-CP.

Article 3. Delegation of implementation of certain tasks and resolution of certain administrative procedures in the field of pharmaceuticals within the authority of the Ministry of Health to the Traditional Medicine Management Agency

1. Implementation of certain tasks assigned to the Ministry of Health under Decrees No. 163/2025/NĐ-CP, No. 217/2025/NĐ-CP, and No. 42/2025/NĐ-CP, including:

a) Proposing the wholesale price for traditional prescription drugs that have been announced or re-announced according to Articles 116, 117, 118, and 119 of Decree No. 163/2025/NĐ-CP during their circulation on the market;

b) Amending and correcting the content of advertisements for traditional drugs that have already been confirmed according to Article 109 of Decree No. 163/2025/NĐ-CP;

c) Conducting specialized inspections of organizations and individuals engaged in production, testing, export, import, storage, wholesale, retail, information dissemination, and advertising of traditional drugs, traditional herbal medicines, and medicinal materials according to Clause 1 of Article 6 of Decree No. 217/2025/NĐ-CP;

d) Receiving applications, organizing reviews and evaluations, and submitting to the Minister of Health for issuance, reissuance, amendment, and revocation of certificates of eligibility to operate in the pharmaceutical sector for entities solely producing traditional drugs, traditional herbal medicines, and medicinal materials, and those solely exporting, importing, and providing storage services for such products at the time of application submission, in accordance with the law; coordinating with the Ministry's Office to publish the list of eligible pharmaceutical business entities on the Ministry of Health’s electronic portal as stipulated in Articles 21, 22, and 23 of Decree No. 163/2025/NĐ-CP;

đ) Receiving reports and notifications from agencies and organizations, compiling them, and coordinating with the Ministry's Office to publish on the Ministry of Health’s electronic portal: decisions to revoke certificates of eligibility to operate in the pharmaceutical sector for entities solely producing traditional drugs, traditional herbal medicines, and medicinal materials; information related to imported traditional drugs permitted according to the law; lists of foreign entities supplying traditional drugs, traditional herbal medicines, and medicinal materials to Vietnam as proposed for publication by competent authorities of exporting countries according to the law as stipulated in Article 23, Clause 7 of Article 62, and Article 79 of Decree No. 163/2025/NĐ-CP;

e) Receiving applications, organizing reviews and evaluations, and submitting to the Minister of Health for issuance and revocation of pharmacists' licenses through examinations for practitioners in the field of traditional medicine according to the law and international practices; coordinating with the Ministry's Office to publish the list of individuals issued or revoked pharmacists' licenses through examinations on the Ministry of Health’s electronic portal as stipulated in Articles 5 and 7 of Decree No. 163/2025/NĐ-CP;

g) Issuing, renewing, amending, changing, supplementing, and revoking product certificates for traditional drugs according to Point c, Clause 11 of Article 2 of Decree No. 42/2025/NĐ-CP;

2. Granting export permits for medicinal materials listed in the category of rare, precious, and endemic medicinal materials requiring control (TTHC code 1.014120) according to Clause 1 of Article 49 of Decree No. 163/2025/NĐ-CP;

3. Granting import permits for medicinal materials not covered by Articles 68, 69, 70, and 71 of Decree No. 163/2025/NĐ-CP dated June 29, 2025, except for special controlled raw materials (TTHC code 1.014122) according to Clause 1 of Article 73 of Decree No. 163/2025/NĐ-CP;

4. Granting import permits for traditional drugs without a drug registration certificate in Vietnam containing new drug substances not registered in Vietnam, or containing medicinal materials used for the first time in Vietnam (TTHC code 1.014072) according to Clause 2 of Article 62 of Decree No. 163/2025/NĐ-CP;

5. Granting import permits for traditional drugs without a drug registration certificate in Vietnam containing drug substances already registered in Vietnam but insufficient for treatment needs, or containing medicinal materials previously used in Vietnam but insufficient for treatment needs (TTHC code 1.014073) according to Clause 2 of Article 62 of Decree No. 163/2025/NĐ-CP;

6. Granting import permits for drug substances, semi-finished pharmaceutical products, medicinal materials, and semi-finished medicinal materials for the production of drugs serving defense and security requirements, meeting the demand for prevention and treatment of Category A infectious diseases declared under the law on prevention and control of infectious diseases, and addressing consequences of accidents, disasters, and catastrophes, except for specially controlled raw materials (TTHC code 1.014096) according to Clause 2 of Article 73 of Decree No. 163/2025/NĐ-CP;

7. Granting import permits for specially controlled raw materials for toxic medicinal materials (TTHC code 1.014071) according to Article 67 of Decree No. 163/2025/NĐ-CP;

8. Granting import permits for traditional drugs without a drug registration certificate in Vietnam having the same trade name, active ingredients, dosage, or formulation as the original branded drug registered in Vietnam, produced by the original manufacturer or authorized manufacturers, and priced lower than the original branded drug circulating in Vietnam (TTHC code 1.014083) according to Clause 5 of Article 62 of Decree No. 163/2025/NĐ-CP;

9. Granting import permits for rare traditional drugs without a drug registration certificate in Vietnam (TTHC code 1.014074) according to Clause 2 of Article 62 of Decree No. 163/2025/NĐ-CP.

10. Issuing import permits for traditional medicine drugs that have not obtained a drug circulation registration certificate in Vietnam to meet special treatment needs (TTHC code 1.014082) as stipulated in Clause 5, Article 62 of Decree No. 163/2025/NĐ-CP.

11. Issuing import permits for drugs that have not obtained a drug circulation registration certificate in Vietnam to meet urgent needs for national defense, security, disease prevention and control, disaster relief (TTHC code 1.014091) for traditional medicine drugs as stipulated in Clauses 3 and 4, Article 62 of Decree No. 163/2025/NĐ-CP, excluding the issuance of decisions approving drugs for urgent needs in disease prevention and control, disaster relief, and the examination and decision-making process for cases specified in Point e, Clause 3 and Point e, Clause 4 of Article 62 of Decree No. 163/2025/NĐ-CP.

For cases specified in Point e, Clause 3 and Point e, Clause 4 of Article 62 of Decree No. 163/2025/NĐ-CP, the Traditional Medicine Management Department reports to the Minister of Health for consideration and decision on issuing import permits and implements the issuance of import permits after receiving the Minister's approval.

12. Issuing import permits for active pharmaceutical ingredients, semi-finished drug products, medicinal materials, semi-finished medicinal materials, excipients, and capsules for testing, research, or compounding at healthcare facilities, except for specially controlled raw materials (TTHC code 1.014107) for medicinal materials as stipulated in Clause 1, Article 73 of Decree No. 163/2025/NĐ-CP.

13. Issuing import permits for active pharmaceutical ingredients, semi-finished drug products, medicinal materials, semi-finished medicinal materials, excipients, and capsules for the production of exported drugs, except for specially controlled raw materials (TTHC code 1.014108) for medicinal materials as stipulated in Clause 1, Article 73 of Decree No. 163/2025/NĐ-CP.

14. Issuing import permits for drugs that have not obtained a drug circulation registration certificate in Vietnam for clinical trials, bioequivalence studies, bioavailability assessments, testing samples, scientific research (TTHC code 1.014115) for traditional medicine drugs as stipulated in Points a, b, c, d, đ, e, Clause 5, Article 62 of Decree No. 163/2025/NĐ-CP.

15. Issuing export permits for radioactive drugs; raw materials for drugs that are radioactive substances; drugs and active pharmaceutical ingredients listed in the prohibited substance list for certain industries; toxic drugs; raw materials for toxic drugs (TTHC code 1.014081) for medicinal materials and traditional medicine drugs as stipulated in Clause 1, Article 49 of Decree No. 163/2025/NĐ-CP.

16. Issuing export permits for specially controlled drugs that have been imported for humanitarian medical activities but are not fully utilized (TTHC code 1.014094) for traditional medicine drugs as stipulated in Clause 1, Article 49 of Decree No. 163/2025/NĐ-CP.

17. Issuing export permits for radioactive drugs, raw materials for drugs that are radioactive substances, toxic drugs, raw materials for toxic drugs, and drugs and active pharmaceutical ingredients listed in the prohibited substance list for certain industries for clinical trials, bioequivalence studies, bioavailability assessments, testing samples, scientific research, and registration samples (TTHC code 1.014114) for medicinal materials and traditional medicine drugs as stipulated in Clause 1, Article 49 of Decree No. 163/2025/NĐ-CP.

18. Issuing export permits for drugs and raw materials for drugs that can be exported without a Ministry of Health permit according to Clause 5, Article 60 of the Drug Law, when the entity requests such a permit (TTHC code 1.014097) for medicinal materials and traditional medicine drugs as stipulated in Point b, Clause 5, Article 82 of Decree No. 163/2025/NĐ-CP.

19. Issuing certificates confirming the content of drug advertisements (excluding advertising through organizing seminars, conferences, or events introducing drugs) (TTHC code 1.014093) for traditional medicine drugs as stipulated in Clauses 1, 2, 3, 4, 6, 7, and 8, Article 108 of Decree No. 163/2025/NĐ-CP.

20. Issuing certificates confirming the content of drug advertisements through organizing seminars, conferences, or events introducing drugs (TTHC code 1.014095) for traditional medicine drugs as stipulated in Clauses 1, 2, 3, 4, 6, 7, and 8, Article 108 of Decree No. 163/2025/NĐ-CP.

Decision to allow the change of purpose for using active pharmaceutical ingredients and medicinal materials for producing drugs with circulation registration certificates for the prevention and treatment of Group A infectious diseases announced under the law on preventing and controlling infectious diseases for active pharmaceutical ingredients and medicinal materials that have been imported for other purposes (TTHC code 1.014098) for medicinal materials (excluding semi-finished medicinal materials) as stipulated in Article 84 of Decree No. 163/2025/NĐ-CP.

22. Issuing import permits for drugs that have not obtained a drug circulation registration certificate in Vietnam for display at exhibitions and trade fairs (TTHC code 1.014106) for traditional medicine drugs as stipulated in Clause 5, Article 62 of Decree No. 163/2025/NĐ-CP.

23. Issuing import permits for specially controlled drugs that have obtained a drug circulation registration certificate in Vietnam (TTHC code 1.014079) for traditional medicine drugs as stipulated in Article 67 of Decree No. 163/2025/NĐ-CP.

24. Issuing import permits for drugs that have not obtained a drug circulation registration certificate in Vietnam for aid and humanitarian assistance (TTHC code 1.014086) for traditional medicine drugs as stipulated in Points a, b, c, d, đ, e, h, Clause 2 and Clause 5, Article 62 of Decree No. 163/2025/NĐ-CP.

The Traditional Medicine Management Department reports to the Minister of Health for consideration of issuing import permits for drugs based on the advisory opinion of the council responsible for advising on drug import permits and the commitment of the entity providing the aid regarding the drug having been approved for circulation in the country of manufacture or a member of the ICH or Australia, and the commitment of the recipient entity regarding the responsibility for the safety and efficacy of the drug as stipulated in Point g, Clause 2, Article 62 of Decree No. 163/2025/NĐ-CP, and implements the issuance of the permit after receiving the Minister's approval.

25. Announcing and re-announcing the wholesale price forecast for prescription drugs (TTHC code 1.014118) as traditional medicine drugs as stipulated in Article 114 of Decree No. 163/2025/NĐ-CP.

26. Issuing export permits for specially controlled medicines for aid and humanitarian assistance (procedure code TTHC 1.014124) for traditional medicines as stipulated in Clause 1, Article 49 of Decree No. 163/2025/NĐ-CP.

27. Issuing export and import permits for traditional medicines, traditional medicinal ingredients, and herbal materials; confirming information content of traditional medicines; confirming advertising content of traditional medicines for administrative procedures according to Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and measures to implement the Medicine Law, Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment business conditions within the scope of management of the Ministry of Health, and Decree No. 88/2023/NĐ-CP dated December 11, 2023 of the Government amending and supplementing certain provisions of Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing certain provisions and measures to implement the Medicine Law and Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment business conditions within the scope of management of the Ministry of Health, submitted before July 1, 2025 and currently being processed according to Clause 1, Article 127 of Decree No. 163/2025/NĐ-CP, except where the entity requests implementation according to Law No. 44/2024/QH15 amending and supplementing certain provisions of the Medicine Law No. 105/2016/QH13 or according to Decree No. 163/2025/NĐ-CP.

Article 4. Delegation of tasks to announce the list of clinical trial drugs under the authority of the Ministry of Health to the Department of Science, Technology and Training.

The lead unit shall cooperate with the Ministry's Office to announce the list of drugs used for clinical trials based on the research outline of clinical trials already approved by the Ministry of Health for clearance when importing on the Ministry of Health's electronic portal and the Department of Science, Technology and Training's website according to Clause 3, Article 82 of Decree No. 163/2025/NĐ-CP and Model No. 50 Appendix III issued together with Decree No. 163/2025/NĐ-CP.

Article 5. Effective Date

This Circular takes effect from September 20, 2025.

Article 6. Implementation Organization

The Heads of the Ministry's Office, the Personnel Department, the Drug Administration Department, the Traditional Medicine Administration Department, the Department of Science, Technology and Training, and relevant agencies, organizations, and individuals are responsible for implementing this Circular.

In the course of implementation, if there are difficulties or obstacles, please report to the Ministry of Health (Drug Administration Department and Traditional Medicine Administration Department, Department of Science, Technology and Training) for timely guidance and resolution./.