The Drug Administration of Vietnam grants import licenses for rare drugs that do not have a circulation registration certificate in Vietnam for chemical drugs, herbal drugs, vaccines and biological products.
According to the Ministry of Health , on June 29, 2025, the Government issued Decree No. 163/2025/ND-CP detailing a number of articles and measures to organize and guide the implementation of the Law on Pharmacy. In particular, a number of administrative procedures in the Decree are assigned to the Ministry of Health for implementation, without specifying the specialized units of the Ministry of Health for implementation.
To ensure that the decentralization of administrative procedure settlement is carried out in accordance with the provisions of Clause 1, Article 8 of the Law on Organization of the Government and Clause 2, Article 18 of the Law on Promulgation of Legal Documents, it is necessary to develop a Circular regulating the decentralization of administrative procedure settlement in the pharmaceutical field under the authority of the Ministry of Health .
Decentralization of handling 31 administrative procedures in the pharmaceutical field to the Department of Drug Administration
The draft clearly states that the decentralization of administrative procedure settlement in the pharmaceutical field under the management authority of the Ministry of Health to the Department of Drug Administration includes:
1. License to import pharmaceutical ingredients subject to special control for pharmaceutical ingredients, semi-finished products, excipients, capsule shells, and semi-finished pharmaceutical products.
2. Granting import licenses for drugs that do not have a drug circulation registration certificate in Vietnam containing pharmaceutical ingredients that do not have a drug circulation registration certificate in Vietnam, drugs containing medicinal ingredients used for the first time in Vietnam for chemical pharmaceutical drugs, herbal medicines, vaccines and biological products.
3. Granting import licenses for drugs that do not have a drug circulation registration certificate in Vietnam containing pharmaceutical ingredients that have a drug circulation registration certificate in Vietnam but do not meet treatment needs, drugs containing medicinal herbs that have been used as drugs in Vietnam but do not meet treatment needs for chemical drugs, herbal drugs, vaccines and biological products.
4. Granting licenses to import rare drugs that do not have a drug circulation registration certificate in Vietnam for chemical drugs, herbal drugs, vaccines and biological products.
5. Permission to purchase pharmaceutical ingredients that are addictive drugs, psychotropic drugs, and precursors used to make drugs.
6. Allowing the transfer of pharmaceutical ingredients that are addictive drugs, psychotropic drugs, and precursors used to make drugs.
7. Granting import licenses for drugs that do not have a drug circulation registration certificate in Vietnam to meet special treatment needs for chemical drugs, herbal drugs, vaccines and biological products.
8. Granting a license to import drugs that do not have a drug circulation registration certificate in Vietnam with the same trade name, active ingredients, content or concentration, and dosage form as the original brand name drug with a drug circulation registration certificate in Vietnam, manufactured by the original brand name manufacturer or by an authorized manufacturer, and with a lower price than the original brand name drug circulating in Vietnam for chemical drugs, herbal drugs, vaccines, and biological products.
9. Issuance of import licenses for drugs to meet urgent needs for national defense, security, disease prevention and control, and overcoming consequences of natural disasters and catastrophes applies to chemical drugs, herbal drugs, vaccines and biological products, excluding the issuance of decisions approving drugs for urgent needs in disease prevention and control, and overcoming consequences of natural disasters and catastrophes.
10. Issue a certificate of confirmation of drug advertising content (except for drug advertising through the means of organizing seminars, conferences, and drug introduction events) for chemical drugs, herbal drugs, and biological products.
11. Granting certificates of confirmation of drug advertising content through the means of organizing seminars, conferences, and drug introduction events for chemical drugs, herbal drugs, and biological products.
12. Granting licenses to import pharmaceutical substances, semi-finished pharmaceutical products, medicinal herbs, and semi-finished medicinal herbs to produce drugs to serve national defense and security requirements, to meet the needs of preventing and treating infectious diseases of group A that have been declared epidemics according to the provisions of law on preventing and combating infectious diseases, and to overcome the consequences of incidents, natural disasters, and catastrophes, except for materials that must be specially controlled.
13. Decision to allow the conversion of the purpose of using pharmaceutical substances and medicinal materials to produce drugs that have been granted a drug circulation registration certificate with indications for use in the prevention and treatment of infectious diseases in group A that have been declared epidemics according to the provisions of law on prevention and control of infectious diseases for pharmaceutical substances and medicinal materials that have been granted an import license for use for other purposes for pharmaceutical substances and semi-finished medicinal materials.
14. Issuance of export licenses for drugs and pharmaceutical ingredients that are allowed to be exported without a license from the Ministry of Health according to the provisions of Clause 5, Article 60 of the Law on Pharmacy, where the facility needs to be granted an export license for chemical drugs, herbal drugs, vaccines and biological products, pharmaceutical substances, semi-finished products, excipients, capsule shells, and semi-finished herbal products.
15. Granting licenses to import drugs that do not have a Drug Circulation Registration Certificate in Vietnam for display at exhibitions and fairs applying chemical drugs, herbal drugs, vaccines and biological products.
16. Granting licenses to import pharmaceutical ingredients, semi-finished pharmaceutical products, medicinal herbs, semi-finished pharmaceutical products, excipients, and capsule shells for use as samples for testing, drug research, or drug preparation according to prescriptions at medical examination and treatment facilities, except for raw materials that must be specially controlled for pharmaceutical ingredients, semi-finished products, excipients, capsule shells, and semi-finished pharmaceutical products.
17. Granting licenses to import pharmaceutical ingredients, semi-finished pharmaceutical products, medicinal herbs, semi-finished pharmaceutical products, excipients, and capsule shells to produce exported drugs, except for raw materials subject to special control for pharmaceutical ingredients, semi-finished products, excipients, capsule shells, and semi-finished pharmaceutical products.
18. Granting licenses to export narcotic drugs, psychotropic drugs, precursor drugs, combination drugs containing narcotic substances, combination drugs containing psychotropic substances, combination drugs containing precursors, pharmaceutical ingredients that are narcotic substances, psychotropic substances, and precursors used to make drugs.
19. Granting licenses to export narcotic drugs, psychotropic drugs, precursor drugs, narcotic pharmaceutical substances, psychotropic pharmaceutical substances, precursors used to make drugs, combination drugs containing narcotic pharmaceutical substances, combination drugs containing psychotropic pharmaceutical substances, combination drugs containing precursors for display at exhibitions and fairs.
20. Granting licenses to import drugs subject to special control with a drug circulation registration certificate in Vietnam for chemical drugs, herbal drugs, vaccines and biological products.
21. Granting licenses to export radioactive drugs; radioactive pharmaceutical ingredients; drugs and pharmaceutical ingredients in the list of drugs and pharmaceutical ingredients in the list of substances prohibited from use in certain industries and fields; toxic drugs; toxic pharmaceutical ingredients for chemical drugs, herbal drugs, vaccines and biological products, pharmaceutical ingredients, semi-finished products, excipients, capsule shells, and semi-finished pharmaceutical products.
22. Granting licenses to import drugs that do not have a drug circulation registration certificate in Vietnam for aid and humanitarian aid for chemical drugs, herbal drugs, vaccines and biological products.
23. Granting export licenses for drugs subject to special control that have been granted import licenses to serve humanitarian medical examination and treatment activities but are not fully used for chemical drugs, herbal drugs, vaccines and biological products.
24. Granting licenses to export narcotic drugs, psychotropic drugs, precursor drugs, combination drugs containing narcotic substances, combination drugs containing psychotropic substances, combination drugs containing precursors, narcotic substances, psychotropic substances, precursors used as drugs for the purposes of clinical trials, bioequivalence trials, bioavailability assessment, testing samples, scientific research, registration samples for chemical drugs, herbal drugs, vaccines and biological products, pharmaceutical substances, semi-finished products, excipients, capsule shells, and semi-finished herbal products.
25. Granting licenses to export radioactive drugs, radioactive pharmaceutical ingredients; toxic drugs, toxic pharmaceutical ingredients, drugs and pharmaceutical ingredients in the list of drugs and pharmaceutical ingredients in the list of substances prohibited from use in certain industries and fields for the purposes of clinical trials, bioequivalence testing, bioavailability assessment, testing samples, scientific research, and registration samples for chemical pharmaceutical drugs, herbal medicines, vaccines and biological products, pharmaceutical ingredients, semi-finished products, excipients, capsule shells, and semi-finished pharmaceutical products.
26. Granting licenses to import drugs that do not have a circulation registration certificate in Vietnam for the purpose of clinical trials, bioequivalence testing, bioavailability assessment, testing samples, and scientific research for chemical pharmaceutical drugs, herbal medicines, vaccines, and biological products.
27. Granting licenses to export medicinal herbs on the list of precious, rare, and endemic medicinal species and varieties that must be controlled for semi-finished medicinal herbs.
28. Granting licenses to import medicinal materials not covered by Articles 68, 69, 70 and 71 of Decree No. 163/2025/ND-CP dated June 29, 2025, except for medicinal materials subject to special control for semi-finished medicinal materials.
29. Granting licenses to export drugs subject to special control for aid and humanitarian aid for chemical drugs, herbal drugs, vaccines, and biological products.
30. Announce and re-announce expected wholesale prices for prescription drugs that are chemical drugs, herbal drugs, vaccines, and biological products.
31. Granting licenses for the export and import of drugs, pharmaceutical ingredients, packaging in direct contact with drugs, and standard substances; confirming drug information content; confirming drug advertising content; approving orders for the purchase of addictive drugs, psychotropic drugs, precursor drugs, pharmaceutical ingredients that are addictive drugs, psychotropic drugs, and precursors used to make drugs received before July 1, 2025, according to the provisions of Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP and Decree No. 188/2023/ND-CP of the Government.
Decentralization of handling 24 administrative procedures in the pharmaceutical field to the Department of Traditional Medicine Management
In addition, the draft also clearly states the decentralization of handling 24 administrative procedures in the pharmaceutical field under the management authority of the Ministry of Health to the Department of Traditional Medicine and Pharmacy Management:
1. Granting licenses to export medicinal herbs on the list of precious, rare, and endemic medicinal species and varieties that must be controlled.
2. Granting licenses to import medicinal materials other than those used for testing, drug research or drug preparation at medical examination and treatment facilities; participating in exhibitions and fairs; producing drugs for export; producing drugs to serve national defense and security requirements, meeting the needs of preventing and treating infectious diseases of group A that have been declared epidemics according to the provisions of law on prevention and control of infectious diseases, overcoming the consequences of incidents, natural disasters and catastrophes.
3. Granting import license for drugs containing pharmaceutical ingredients that do not have a drug circulation registration certificate in Vietnam, drugs containing medicinal ingredients used for the first time in Vietnam for traditional drugs.
4. Granting import licenses for drugs containing pharmaceutical ingredients that have been registered for circulation in Vietnam but do not meet treatment needs, drugs containing medicinal herbs that have been used as medicine in Vietnam but do not meet treatment needs for traditional medicine.
5. Granting licenses to import pharmaceutical substances, semi-finished pharmaceutical products, medicinal herbs, and semi-finished medicinal herbs to produce drugs to serve national defense and security requirements, to meet the needs of preventing and treating infectious diseases of group A that have been declared epidemics according to the provisions of law on preventing and combating infectious diseases, and to overcome the consequences of incidents, natural disasters, and catastrophes, except for raw materials that must be specially controlled for medicinal herbs.
6. License to import pharmaceutical ingredients subject to special control for traditional medicines.
7. Granting a license to import drugs with the same trade name, active ingredients, content or concentration, and dosage form as the original brand name drug with a drug circulation registration certificate in Vietnam, manufactured by the original brand name drug manufacturer or by an authorized manufacturer, and with a lower price than the original brand name drug circulating in Vietnam for traditional drugs.
8. Granting import license for rare drugs for traditional medicine.
9. Granting import licenses for drugs that meet special treatment needs for traditional medicines.
10. Granting import licenses for drugs to meet urgent needs for national defense, security, disease prevention and control, and overcoming the consequences of natural disasters and catastrophes for traditional medicines.
11. Granting licenses to import pharmaceutical ingredients, semi-finished pharmaceutical products, medicinal herbs, semi-finished pharmaceutical products, excipients, and capsule shells for use as samples for testing, drug research, or drug preparation according to prescriptions at medical examination and treatment facilities, except for raw materials that must be specially controlled for medicinal herbs.
12. Granting licenses to import pharmaceutical ingredients, semi-finished pharmaceutical products, medicinal herbs, semi-finished pharmaceutical products, excipients, and capsule shells for the production of exported drugs, except for raw materials subject to special control for medicinal herbs.
13. Granting import licenses for drugs used for clinical trials, bioequivalence testing, bioavailability assessment, testing samples, and scientific research on traditional medicines.
14. Granting licenses to export radioactive drugs; radioactive pharmaceutical ingredients; drugs and pharmaceutical ingredients in the list of drugs and pharmaceutical ingredients in the list of substances prohibited from use in certain industries and fields; toxic drugs; toxic pharmaceutical ingredients for medicinal herbs and traditional medicines.
15. Granting export licenses for specially controlled drugs that have been granted import licenses to serve humanitarian medical examination and treatment activities but are not fully used for traditional medicines.
16. Granting licenses to export radioactive drugs, pharmaceutical ingredients that are radioactive substances, toxic drugs, toxic pharmaceutical ingredients, drugs and pharmaceutical ingredients in the list of drugs and pharmaceutical ingredients in the list of substances prohibited from use in certain industries and fields for the purposes of clinical trials, bioequivalence testing, bioavailability assessment, testing samples, scientific research, and registration samples for medicinal herbs and traditional medicines.
17. Issuance of export licenses for drugs and pharmaceutical ingredients that are allowed to be exported without a license from the Ministry of Health according to regulations in Clause 5, Article 60 of the Law on Pharmacy, where the facility needs to be granted an export license for medicinal herbs and traditional medicines.
18. Issuance of certificate of confirmation of drug advertising content (except for drug advertising through the means of organizing seminars, conferences, and drug introduction events) for traditional drugs.
19. Issuance of certificates of confirmation of drug advertising content through the organization of seminars, conferences, and drug introduction events applicable to traditional drugs.
20. Decision to allow the conversion of the purpose of using pharmaceutical substances and medicinal materials to produce drugs that have been granted a drug circulation registration certificate with indications for use in the prevention and treatment of infectious diseases in group A that have been declared epidemics according to the provisions of law on prevention and control of infectious diseases for pharmaceutical substances and medicinal materials that have been granted an import license for use for other purposes for medicinal materials.
21. Granting import licenses for drugs that do not have a Certificate of Circulation Registration in Vietnam for display at exhibitions and fairs for traditional medicines.
22. Granting import licenses for special controlled drugs with drug circulation registration certificates in Vietnam for traditional drugs.
23. Granting import licenses for drugs that do not have a circulation registration certificate in Vietnam for aid and humanitarian aid for traditional medicines.
24. Announce and re-announce expected wholesale prices for prescription drugs that are traditional medicines.
The Ministry of Health is soliciting comments on this draft on the Ministry's Information Portal.
Minh Hien
Source: https://baochinhphu.vn/de-xuat-phan-cap-giai-quyet-thu-tuc-hanh-chinh-linh-vuc-duoc-thuoc-tham-quyen-cua-bo-y-te-102250806110413926.htm
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