Proposal to decentralize the settlement of some administrative procedures in the pharmaceutical sector

Decentralization of handling some administrative procedures in the pharmaceutical field under the authority of the Ministry of Health to the Department of Drug Administration

1- Granting licenses for importing pharmaceutical ingredients subject to special control (TTHC code 1.014071) for pharmaceutical ingredients that are addictive drugs, psychotropic drugs, precursors used to make drugs, radioactive substances, pharmaceutical ingredients in the list of drugs, pharmaceutical ingredients in the list of substances prohibited from use in certain industries and fields, toxic ingredients for making drugs except toxic pharmaceutical ingredients.

2- Granting import license for drugs without a drug circulation registration certificate in Vietnam containing pharmaceutical ingredients without a drug circulation registration certificate in Vietnam, drugs containing medicinal herbs used for the first time in Vietnam (TTHC code 1.014072) for chemical drugs, herbal drugs, vaccines and biological products.

3- Granting import license 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 (TTHC code 1.014073) for chemical drugs, herbal drugs, vaccines and biological products.

4- Granting import license for rare drugs without circulation registration certificate in Vietnam (TTHC code 1.014074) 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 (TTHC code 1.014077).

6- Permission to transfer pharmaceutical ingredients that are addictive drugs, psychotropic drugs, and precursors used to make drugs (TTHC code 1.014080).

7- Granting import license for drugs without circulation registration certificate in Vietnam to meet special treatment needs (TTHC code 1.014082) 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 (TTHC code 1.014083) for chemical drugs, herbal drugs, vaccines, and biological products.

9- Issuing licenses to import drugs that do not have a drug circulation registration certificate in Vietnam to meet urgent needs for national defense, security, disease prevention and control, and overcoming consequences of natural disasters and catastrophes (TTHC code 1.014091) for chemical drugs, herbal drugs, vaccines and biological products, excluding the issuance of decisions approving drugs for urgent needs in disease prevention and control, overcoming consequences of natural disasters and catastrophes.

10- Issuance of certificate of confirmation of drug advertising content (except for drug advertising through the means of organizing seminars, conferences, and drug introduction events) (TTHC code 1.014093) for chemical drugs, herbal drugs, and biological products.

11- Issuing a certificate of confirmation of drug advertising content through the means of organizing seminars, conferences, and drug introduction events (TTHC code 1.014095) for chemical drugs, herbal drugs, and biological products.

12- Granting licenses to import pharmaceutical ingredients, semi-finished pharmaceutical products, medicinal herbs, and semi-finished pharmaceutical products 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 prevention and control of infectious diseases, and to overcome the consequences of incidents, natural disasters, and catastrophes, except for raw materials that must be specially controlled (TTHC code 1.014096) for pharmaceutical ingredients, semi-finished pharmaceutical products, and semi-finished pharmaceutical products.

13- Decision to allow 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 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 for pharmaceutical substances and medicinal materials that have been licensed for import for other purposes (TTHC code 1.014098) 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 (TTHC code 1.014097) for chemical drugs, herbal drugs, vaccines and biological products, pharmaceutical substances, semi-finished products, excipients, capsule shells, and semi-finished herbal products.

15- Granting import license for drugs without a Drug Circulation Registration Certificate in Vietnam for display at exhibitions and fairs (TTHC code 1.014106) for 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 at medical examination and treatment facilities, except for materials subject to special control (TTHC code 1.014107) 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 (TTHC code 1.014108) for pharmaceutical ingredients, semi-finished products, excipients, capsule shells, and semi-finished pharmaceutical products.

18- Granting licenses to export addictive drugs, psychotropic drugs, precursor drugs, combination drugs containing addictive substances, combination drugs containing psychotropic substances, combination drugs containing precursors, pharmaceutical ingredients that are addictive substances, psychotropic substances, precursors used to make drugs (TTHC code 1.014109).

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 (TTHC code 1.014110).

20- Granting import licenses for drugs subject to special control with a certificate of drug circulation registration in Vietnam (TTHC code 1.014079) for addictive drugs, psychotropic drugs, precursor drugs, combination drugs containing addictive drugs, combination drugs containing psychotropic drugs, combination drugs containing precursors, radioactive drugs; drugs in the list of drugs, pharmaceutical substances on the list of substances prohibited from use in a number of industries and fields; toxic drugs except for toxic traditional drugs.

21- Granting licenses to export radioactive drugs; radioactive pharmaceutical ingredients; drugs and pharmaceutical ingredients in the list of drugs and pharmaceutical ingredients on the list of substances prohibited from use in certain industries and fields; toxic drugs; toxic pharmaceutical ingredients (TTHC code 1.014081) for radioactive drugs; radioactive pharmaceutical ingredients; drugs and pharmaceutical ingredients in the list of drugs and pharmaceutical ingredients on the list of substances prohibited from use in certain industries and fields; toxic drugs except for toxic traditional drugs; toxic pharmaceutical ingredients except for toxic medicinal herbs.

22- Granting licenses to import drugs without a drug circulation registration certificate in Vietnam for aid and humanitarian aid (TTHC code 1.014086) for chemical drugs, herbal drugs, vaccines and biological products.

23- Issuance of export license for specially controlled drugs that have been licensed for import to serve humanitarian medical examination and treatment activities but are not fully used (TTHC code 1.014094) for chemical drugs, herbal drugs, vaccines and biological products.

24- Granting licenses to export addictive drugs, psychotropic drugs, precursor drugs, combination drugs containing addictive substances, combination drugs containing psychotropic substances, combination drugs containing precursors, addictive substances, psychotropic substances, precursors used as drugs for the purposes of clinical trials, bioequivalence testing, bioavailability assessment, testing samples, scientific research, and registration samples (TTHC code 1.014112).

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 on the list of substances prohibited from use in a number of industries and fields for the purpose of clinical trials, bioequivalence testing, bioavailability assessment, testing samples, scientific research, and registration samples (TTHC code 1.014114) for radioactive drugs, radioactive pharmaceutical ingredients; toxic drugs except for toxic traditional drugs, toxic pharmaceutical ingredients for drugs, drugs and pharmaceutical ingredients in the list of drugs and pharmaceutical ingredients on the list of substances prohibited from use in a number of industries and fields.

26- Granting import license for drugs not yet registered for circulation in Vietnam for the purpose of clinical trials, bioequivalence testing, bioavailability assessment, testing samples, scientific research (TTHC code 1.014115) for chemical drugs, herbal drugs, vaccines and biological products.

27- Granting license to export medicinal herbs in the list of precious, rare, and endemic medicinal herb species and varieties that must be controlled (TTHC code 1.014120) for semi-finished medicinal herb products.

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 (TTHC code 1.014122) for semi-finished medicinal materials.

29- Granting licenses for the export of drugs subject to special control for aid and humanitarian aid (TTHC code 1.014124) for addictive drugs, psychotropic drugs, precursor drugs, combination drugs containing addictive substances, combination drugs containing psychotropic substances, combination drugs containing precursors, radioactive drugs; drugs in the list of drugs and pharmaceutical substances on the list of substances prohibited from use in certain industries and fields; toxic drugs except for toxic traditional drugs.

30- Announce and re-announce expected wholesale prices for prescription drugs (TTHC code 1.014118) which 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 for dossiers carrying out administrative procedures according to the provisions of Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP and Decree No. 88/2023/ND-CP of the Government submitted before July 1, 2025.

32- Carry out the tasks assigned by the Ministry of Health in Decree No. 163/2025/ND-CP dated June 29, 2025 of the Government detailing a number of articles and measures to organize and guide the implementation of the Law on Pharmacy and Decree No. 217/2025/ND-CP dated August 5, 2025 of the Government on specialized inspection activities.

33- Perform the tasks specified in the Decision stipulating the functions, tasks, powers and organizational structure of the Department of Drug Administration under the Ministry of Health.

Decentralization of handling 28 administrative procedures in the pharmaceutical field under the authority of the Ministry of Health to the Department of Traditional Medicine and Pharmacy Management

The draft clearly states that the implementation of a number of tasks and the settlement of a number of administrative procedures in the pharmaceutical field under the authority of the Ministry of Health is delegated to the Department of Traditional Medicine and Pharmacy Management:

1. Granting license to export medicinal herbs in the list of precious, rare, and endemic medicinal herb species and varieties that must be controlled (TTHC code 1.014120) for medicinal herbs.

2. 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 (TTHC code 1.014122) for medicinal materials.

3. Granting import license for drugs without a drug circulation registration certificate in Vietnam containing pharmaceutical ingredients without a drug circulation registration certificate in Vietnam, drugs containing medicinal herbs used for the first time in Vietnam (TTHC code 1.014072) for traditional drugs.

4. Granting import license 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 (TTHC code 1.014073) for traditional drugs.

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 prevention and control of infectious diseases, and to overcome the consequences of incidents, natural disasters, and catastrophes, except for raw materials that must be specially controlled (TTHC code 1.014096) for medicinal herbs.

6. Granting license to import controlled pharmaceutical ingredients (TTHC code 1.014071) for toxic medicinal materials.

7. 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 (TTHC code 1.014083) for traditional drugs.

8. Granting import license for rare drugs without circulation registration certificate in Vietnam (TTHC code 1.014074) for traditional drugs.

9. Granting import license for drugs without circulation registration certificate in Vietnam to meet special treatment needs (TTHC code 1.014082) for traditional drugs.

10. Granting import licenses for drugs that do not have a drug circulation registration certificate in Vietnam to meet urgent needs for national defense, security, disease prevention and control, and overcoming consequences of natural disasters and catastrophes (TTHC code 1.014091) for traditional drugs.

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 at medical examination and treatment facilities, except for materials subject to special control (TTHC code 1.014107) 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 (TTHC code 1.014108) for medicinal herbs.

13. Granting import license for drugs not yet registered for circulation in Vietnam for the purpose of clinical trials, bioequivalence testing, bioavailability assessment, testing samples, scientific research (TTHC code 1.014115) for traditional drugs.

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 (TTHC code 1.014081) for toxic medicinal herbs and toxic traditional medicines.

15. Granting export license for specially controlled drugs that have been granted import license to serve humanitarian medical examination and treatment activities but are not fully used (TTHC code 1.014094) for traditional medicines.

16. Granting licenses to export radioactive drugs, pharmaceutical ingredients that are radioactive substances, 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 (TTHC code 1.014114) 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 (TTHC code 1.014097) for toxic medicinal herbs and toxic 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) (TTHC code 1.014093) for traditional drugs.

19. Issuance of certificate of confirmation of drug advertising content through the means of organizing seminars, conferences, and drug introduction events (TTHC code 1.014095) for traditional drugs.

20. Decision to allow 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 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 licensed for import for other purposes (TTHC code 1.014098) for medicinal materials (excluding semi-finished medicinal products).

21. Granting import license for drugs without Circulation Registration Certificate in Vietnam for display at exhibitions and fairs (TTHC code 1.014106) for traditional drugs.

22. Granting import license for specially controlled drugs with drug circulation registration certificate in Vietnam (TTHC code 1.014079) for toxic traditional drugs.

23. Granting import license for drugs without drug circulation registration certificate in Vietnam for aid and humanitarian aid (TTHC code 1.014086) for traditional drugs.

24. Announce and re-announce expected wholesale prices for prescription drugs (TTHC code 1.014118) which are traditional drugs.

25. Granting export licenses for drugs subject to special control for aid and humanitarian aid (TTHC code 1.014124) for toxic traditional drugs.

26. Granting of Pharmacy Practice Certificates in the form of examinations in cases where the Pharmacy Practice Certificate is recorded incorrectly due to the fault of the Pharmacy Practice Certificate granting agency (TTHC code 1.014085) for practitioners in the field of traditional medicine.

27. Granting of Pharmacy Practice Certificates (including cases of granting Pharmacy Practice Certificates to people whose Pharmacy Practice Certificates have been revoked as prescribed in Clauses 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, Article 28 of the Law on Pharmacy) in the form of examination (TTHC code 1.014084) for practitioners in the field of traditional medicine.

28. Carry out the tasks assigned by the Ministry of Health in Decree No. 163/2025/ND-CP dated June 29, 2025 of the Government detailing a number of articles and measures to organize and guide the implementation of the Law on Pharmacy.

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-mot-so-tthc-linh-vuc-duoc-102250822164531827.htm