The list of wholly online public services announced by the Ministry of Health of Vietnam

No

 Code

Name of administrative procedure

Field

Level of resolution

I

Pharmaceutical field: 83 administrative procedures at central level; 16 Provincial administrative procedures

first

1.011205

Procedures for granting registration certificates for circulation of new pharmaceutical drugs, vaccines, and biochemicals

Medicine

center

2

1.011206

Procedures for granting registration certificates for circulation of generic drugs

center

3

1.011207

Procedures for granting registration certificates for circulation of medicinal drugs

center

4

1.011208

Procedures for granting registration certificates for circulation of medicinal ingredients

center

5

1.011209

Procedures for extending registration certificates for circulation of drugs and medicinal ingredients

center

6

1.011215

Procedures for changing and supplementing circulation registration certificates for drugs and medicinal ingredients are subject to major changes

center

7

1.011217

Procedures for changing and supplementing circulation registration papers for drugs and medicinal ingredients - Minor changes requiring approval

center

8

1.011220

Procedures for changing and supplementing circulation registration certificates for drugs and medicinal ingredients - Minor changes only require notification to the management agency

center

9

1.011225

Procedures for revocation of registration certificate for circulation of drugs and medicinal ingredients in case the manufacturing facility or establishment registering drugs or medicinal ingredients requests revocation of registration certificate for circulation of drugs or medicinal ingredients in Vietnam Male

center

ten

1.011840

Procedures for granting circulation registration certificates for processed drugs and technology transfer drugs in cases where drugs ordered for processing or drugs before technology transfer already have a circulation registration certificate in Vietnam that is still valid at the time of submission. file

center

11

1.011841

Procedures for granting circulation registration papers for processed drugs and technology transfer drugs in cases where drugs ordered for processing or drugs before technology transfer do not have a circulation registration certificate in Vietnam or a circulation registration certificate in Vietnam. Vietnam expires at the time of application submission

center

twelfth

1.011842

Procedures for granting a certificate of circulation registration for processed drugs with transfer of drug production technology from the facility ordering drug processing to the facility receiving drug processing in cases where the processed drug already has a certificate of circulation registration in Vietnam. Vietnam is still valid at the time of application submission

center

13

1.011843

Procedures for granting a certificate of circulation registration for processed drugs with transfer of drug production technology from the facility ordering drug processing to the facility receiving drug processing in cases where the processed drug does not have a certificate of circulation registration in Vietnam. Vietnam or the registration certificate for circulation in Vietnam expires at the time of application submission

center

14

1.011844

Procedures for extension of registration papers for circulation of processed drugs and technology transferred drugs

center

15

1.011845

Procedures for changing and supplementing circulation registration certificates for processed drugs and technology transferred drugs - Subject to major changes

center

16

1.011846

Procedures for changing and supplementing circulation registration papers for processed drugs and technology transferred drugs - Minor changes requiring approval

center

17

1.011847

Procedures for changing and supplementing circulation registration certificates for processed drugs and technology transferred drugs - Minor changes only require notification to the management agency

center

18

1.004589

Evaluate the compliance with good manufacturing practices of establishments producing drugs and medicinal ingredients that are pharmaceutical substances in the form of recognition and recognition of inspection and examination results of state pharmaceutical management agencies

center

19

1.004582

Evaluate the compliance with good manufacturing practices of a facility that produces drugs and medicinal ingredients that are pharmaceutical substances in the form of appraisal of documents related to production conditions and inspection at the manufacturing facility.

center

20

1.004570

Evaluate the compliance with good manufacturing practices of foreign manufacturers of medicinal ingredients such as excipients and capsule shells when registering and circulating in Vietnam

center

21

2.000952

Assessment of compliance with Good Laboratory Practices for pharmaceutical businesses

center

22

2.000917

Assessment meets Good Laboratory Practice for non-commercial testing facilities

center

23

1.003136

Evaluation maintained to meet good laboratory practice

center

24

1.003068

Change control when there is a change in one of the cases specified in Points d, dd and e Clause 1 Article 11 Circular 04/2018/TT-BYT

center

25

1.008437

Assessment of maintaining compliance with Good Manufacturing Practices for drugs and medicinal ingredients of establishments that are not subject to issuance of a certificate of eligibility for pharmaceutical business.

center

26

1.008438

Evaluate compliance with good manufacturing practices for drugs and medicinal ingredients when there is a change in the case specified in Point a, Clause 2, Article 11 of Circular 35/2018/TT-BYT

center

27

1.008226

Evaluate compliance with good manufacturing practices for drugs and medicinal ingredients for pharmaceutical business establishments

center

28

1.008227

Assessment of compliance with Good Manufacturing Practices for drugs and medicinal ingredients of establishments that are not subject to issuance of a certificate of eligibility for pharmaceutical business.

center

29

1.008228

Evaluate and maintain compliance with Good Manufacturing Practices for drugs and medicinal ingredients for pharmaceutical business establishments

center

30

2.002315

Issue a Certificate of eligibility for pharmaceutical business with the scope of drug bioequivalence testing

center

thirty first

1.011456

Assessment of compliance with good manufacturing practices for drugs and medicinal ingredients when there are changes in the cases specified in Points b, c or d, Clause 2, Article 11 or in cases where the manufacturing facility produces drugs and raw materials for making drugs. Sterile drugs have changes under Points dd, e and g, Clause 2, Article 11 of Circular 35/2018/TT-BYT

center

32

1.011457

Declaration of compliance with EU-GMP standards or equivalent EU-GMP standards for drug manufacturing facilities

center

33

1.004491

Declare prices of domestically produced drugs or foreign drugs imported into Vietnam

center

34

1.004620

Re-declare prices of foreign drugs imported into Vietnam

center

35

1.004618

Supplementing or changing information about declared drugs, re-declaring prices in case there is a change compared to published information but the drug price remains unchanged.

center

36

1.004548

Issuing a certificate of drug advertising content (except for drug advertising through the means of organizing seminars, conferences, and drug introduction events)

center

37

1.004543

Issuing a certificate of drug information content in the form of issuing drug information documents

center

38

1.004517

Issuing certificates of drug advertising content through the organization of seminars, conferences, and drug introduction events

center

39

1.008443

Assessment of compliance with good storage practices for drugs and medicinal ingredients for pharmaceutical businesses

center

40

1.008444

Evaluation of maintaining compliance with good storage practices for drugs and medicinal ingredients for pharmaceutical businesses.

center

41

1.008445

Evaluate compliance with good storage practices for drugs and medicinal ingredients when there is a change in the case specified in Point a, Clause 1, Article 11 of Circular 36/2018/TT-BYT

center

42

1.008446

Evaluate compliance with good storage practices for drugs and medicinal ingredients when there are changes in the cases specified in Point b, Clause 1, Article 11 of Circular 36/2018/TT-BYT

center

43

1.008447

Evaluate compliance with good storage practices for drugs and medicinal ingredients when there are changes in the cases specified in Point c, Clause 1, Article 11 of Circular 36/2018/TT-BYT

center

44

1.008448

Evaluate compliance with good storage practices for drugs and medicinal ingredients when there are changes in the cases specified in Points d, dd or e, Clause 1, Article 11 of Circular 36/2018/TT-BYT.

center

45

1.004405

Allows destruction of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, and drug precursors under the authority of the Ministry of Health.

center

forty six

1.004404

Allowing the purchase of narcotic drugs, psychotropic drugs, and precursor drugs under the authority of the Ministry of Health

center

47

1.004402

Allowing the purchase of medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients and drug precursors under the authority of the Ministry of Health.

center

48

1.004401

Allows manufacturing facilities to transfer medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, and medicinal precursors

center

49

1.004400

License to export narcotic drugs, psychotropic drugs, precursor drugs, combined drugs containing narcotic active ingredients, combined drugs containing psychotropic active ingredients, combined drugs containing precursors, raw materials Drugs are addictive pharmaceutical substances, psychotropic pharmaceutical substances, and precursors used as drugs

center

50

1.004390

License to export drugs subject to special control for aid and humanitarian aid

center

51

1.004388

License to export drugs subject to special control that have been licensed to be imported to serve humanitarian medical examination and treatment activities but are not fully used

center

52

1.003944

License to export narcotic drugs, psychotropic drugs, precursor drugs, narcotic active ingredients, psychotropic active ingredients, drug precursors, combined drugs containing narcotic active ingredients, combined drugs containing narcotic drugs Psychotropic substances and combination drugs containing precursors for display at exhibitions and fairs

center

53

1.003931

License to export narcotic drugs, psychotropic drugs, precursor drugs, combined drugs containing narcotic active ingredients, combined drugs containing psychotropic active ingredients, combined drugs containing precursors, narcotic active ingredients addiction, psychotropic drugs, drug precursors for clinical testing, bioequivalence testing, bioavailability assessment, testing samples, scientific research, registration samples

center

54

1.004522

License to import drugs subject to special control with drug circulation registration certificate in Vietnam

center

55

1.004556

License to import medicinal ingredients subject to special control

center

56

1.004597

License to import excipients, capsule shells, packaging in direct contact with drugs and standard substances

center

57

1.001396

Providing radioactive drugs

center

58

1.004397

License to export radioactive drugs; drugs and pharmaceutical substances on the list of drugs and pharmaceutical substances on the list of substances banned from use in a number of industries and fields; poison; toxic medicinal ingredients

center

59

1.003902

License to export radioactive drugs, toxic drugs, toxic medicinal ingredients, drugs and pharmaceutical substances on the list of drugs, pharmaceutical substances on the list of substances banned from use in a number of industries and fields for clinical trial purposes, bioequivalence testing, bioavailability assessment, testing samples, scientific research, registration samples

center

60

1.003873

Licensing the export of drugs and medicinal 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 Pharmacy Law if the facility needs an export license.

center

sixty one

1.003756

Licensing the import of drugs containing medicinal substances that do not have a drug registration certificate in Vietnam, drugs containing medicinal substances used as medicine for the first time in Vietnam

center

62

1.004463

Licensing the import of drugs containing medicinal substances that have a drug registration certificate in Vietnam but do not fully meet treatment needs, drugs that contain medicinal ingredients that have been used as medicine in Vietnam but that do not fully meet treatment needs. treatment needs

center

63

1.004472

Licensing to import drugs to meet urgent needs for national defense, security, disease prevention and control, and overcoming the consequences of natural disasters and catastrophes

center

sixty four

1.004483

License to import drugs to meet special treatment needs

center

65

1.004501

License to import rare drugs

center

66

1.004533

License to import drugs with the same trade name, active ingredient, content or concentration, dosage form as the original brand name drug with drug registration certificate in Vietnam, produced by the brand name drug manufacturer original drug or by an authorized manufacturer, has a lower price than the original brand-name drug circulating in Vietnam

center

sixty seven

1.004547

License to import drugs for the State's health program

center

68

1.004476

Licensing to import aid drugs and humanitarian aid

center

69

1.004505

License to import drugs for clinical testing, bioequivalence testing, bioavailability assessment, testing samples, and scientific research

center

70

1.004511

License to import combination drugs containing narcotic drugs, combination drugs containing psychotropic drugs, combination drugs containing precursors for display at exhibitions and fairs related to medicine and pharmacy , medical equipment

center

71

1.004609

License to import pharmaceutical substances, semi-finished drug products, medicinal materials, semi-finished medicinal materials for use as testing samples, drug research, except for materials subject to special control

center

72

1.004608

License to import pharmaceutical substances, semi-finished drugs, medicinal materials, semi-finished pharmaceutical products to produce drugs for export, except for materials subject to special control

center

seventy three

1.004601

Licensing the import of pharmaceutical substances, semi-finished drug products, medicinal materials, semi-finished pharmaceutical products to produce drugs to serve the requirements of national defense, security, disease prevention and control, overcoming the consequences of natural disasters and catastrophes, Except for materials that require special control

center

74

1.004559

Allowing the import of drugs and medicinal ingredients whose remaining shelf life at the time of customs clearance is shorter than prescribed

center

75

1.004534

Issuing a Pharmacy Practice Certificate (including cases where a Pharmacy Practice Certificate is issued but the Pharmacy Practice Certificate is revoked according to the provisions of Clauses 1, 2, 4, 5, 6, 7, 8, 9, 10 , 11 Article 28 of the Pharmacy Law) in the form of exam

center

76

1.004523

Issuing a Pharmacy Practice Certificate in the form of an exam in case the Pharmacy Practice Certificate is incorrectly written due to the error of the pharmacy practice certificate-issuing agency.

center

77

1.004513

Re-issuance of Pharmacy Practice Certificate by exam form

center

78

1.004495

Adjust the content of the Pharmacy Practice Certificate according to the exam format

center

79

1.004482

First-time issuance and issuance of Certificate of eligibility for business in cases where the Certificate of eligibility for pharmaceutical business is revoked under the authority of the Ministry of Health (Establishments producing drugs and medicinal ingredients; Establishments Exporting and importing drugs and medicinal ingredients; Establishments providing drug and medicinal ingredient storage services; Establishments providing drug and medicinal ingredient testing services; clinical practice; Establishments providing drug bioequivalence testing services).

center

80

1.004469

Issuing a Certificate of eligibility for pharmaceutical business to establishments that change the type of business or scope of pharmaceutical business and change business conditions or change business location under the authority of the Ministry of Health (Establishments Manufacturing drugs and medicinal ingredients; Establishments exporting and importing drugs and medicinal ingredients; Establishments providing drug and medicinal ingredient storage services; Establishments providing drug and raw material testing services making drugs; Establishments providing clinical drug testing services; Establishments providing bioequivalence testing services of drugs).

center

81

1.004454

Re-issuance of Certificate of eligibility for pharmaceutical business under the authority of the Ministry of Health (Facility manufacturing drugs and medicinal ingredients; Establishments exporting and importing drugs and medicinal ingredients; Establishments providing business services storage of drugs and medicinal ingredients; Establishments providing drug and medicinal ingredient testing services; Establishments providing clinical drug testing services; Establishments providing drug bioequivalence testing services) .

center

82

1.004406

Adjusting the Certificate of eligibility for pharmaceutical business under the authority of the Ministry of Health (Facility manufacturing drugs and medicinal ingredients; Establishments exporting and importing drugs and medicinal ingredients; Establishments providing business services storage of drugs and medicinal ingredients; Establishments providing drug and medicinal ingredient testing services; Establishments providing clinical drug testing services; Establishments providing drug bioequivalence testing services) .

center

83

1.002112

Issuing Certificate of eligibility for pharmaceutical business to establishments trading drugs subject to special control under the authority of the Ministry of Health

center

84

1.004616

Issuing a Pharmacy Practice Certificate (including cases where a Pharmacy Practice Certificate is issued but the Pharmacy Practice Certificate is revoked according to the provisions of Clauses 1, 2, 4, 5, 6, 7, 8, 9, 10 , 11 Article 28 of the Pharmacy Law) in the form of document review

Conscious

85

1.004604

Issuance of Pharmacy Practice Certificate by reviewing documents in case the Pharmacy Practice Certificate is incorrectly written due to the error of the Pharmacy Practice Certificate-issuing agency.

Conscious

eighty six

1.004599

Re-issuance of Pharmacy Practice Certificate by reviewing documents (in case of damage or loss)

Conscious

eighty seven

1.004596

Adjust the content of the Pharmacy Practice Certificate according to the form of application review

Conscious

88

1.004576

Re-issuance of the Certificate of eligibility for pharmaceutical business under the authority of the Department of Health (Wholesale establishments of drugs and medicinal ingredients; Drug retail establishments including pharmacies, pharmacy counters, medicine cabinets at commune health stations, Establishments specializing in retailing medicinal herbs, herbal medicines, traditional medicines)

Conscious

89

1.004571

Adjusting the Certificate of eligibility for pharmaceutical business under the authority of the Department of Health (Wholesale establishments of drugs and medicinal ingredients; Drug retail establishments including pharmacies, pharmacy counters, medicine cabinets at commune health stations, Establishments specializing in retailing medicinal herbs, herbal medicines, traditional medicines)

Conscious

90

1.004557

Announcement of mobile drug retail activities

Conscious

91

1.004532

Allows destruction of narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic active ingredients, psychotropic active ingredients, and drug precursors under the authority of the Department of Health.

Conscious

92

1.004529

Allowing the purchase of narcotic drugs, psychotropic drugs, and precursor drugs under the authority of the Department of Health

Conscious

93

1.004459

Allow retail sale of drugs on the List of drugs restricted from retail for establishments that have been granted a Certificate of eligibility for pharmaceutical business

Conscious

ninety four

1.004449

License to export drugs subject to special control belonging to personal luggage of organizations or individuals exiting the country sent under bills of lading, goods carried by organizations or individuals exiting the country to treat their own illnesses. exported and not a medicinal ingredient subject to special control

Conscious

95

1.004087

Licensing the import of drugs belonging to the personal luggage of organizations and individuals entering the country and sent under bills of lading, and goods carried by organizations and individuals entering the country to treat the illness of the person entering the country

Conscious

96

1.002934

Change control when there is a change in one of the cases specified in Points c and d Clause 1 Article 11 Circular 02/2018/TT-BYT

Conscious

97

1.002235

Change control when there is a change in one of the cases specified in Points d, dd and e Clause 1 Article 11 Circular 03/2018/TT-BYT

Conscious

98

1.001893

Announcement of business establishments with organized medicine shelves

Conscious

99

1.003963

Issue a certificate of drug information content in the form of a drug introduction seminar

Conscious

II

Cosmetics field: 3 administrative procedures at central level; 07 Provincial level administrative procedures.

first

1.002088

Issuance of receipt number for declaration of imported cosmetic products

Cosmetics

center

2

1.002257

Issuing a certificate that the facility meets the principles and standards of "Good Cosmetic Manufacturing Practices" of the Association of Southeast Asian Nations (CGMP-ASEAN)

center

3

1.002238

Confirmation of orders to import cosmetics for research and testing

center

4

1.002483

Issue a certificate of cosmetic advertising content

Conscious

5

1.000990

Re-issue the certificate of cosmetic advertising content in case it is lost or damaged

Conscious

6

1.000793

Re-issue the certificate of cosmetic advertising content in case it expires in Clause 2, Article 21 of Circular No. 09/2015/TT-BYT

Conscious

7

1.000662

Reissue the certificate of cosmetic advertising content when there is a change in the name and address of the responsible organization or individual and there is no change in the advertising content.

Conscious

8

1.003073

Adjust the Certificate of eligibility for cosmetic manufacturing

Conscious

9

1.002600

Issue the number to receive the Declaration of domestically produced cosmetic products

Conscious

ten

1.009566

Issue Certificate of Free Circulation (CFS) for domestically produced cosmetics for export

Conscious

III

Traditional medicine and pharmacy field: 03 administrative procedures at central level

first

1.008395

Assessment of compliance with Good Practices for cultivating and harvesting medicinal herbs and principles and standards for exploiting natural medicinal herbs (GACP)

Traditional Medicine

center

2

1.008396

Evaluate and maintain compliance with Good Cultivation and Collection Practices of medicinal herbs and principles and standards for exploiting natural medicinal herbs (GACP)

center

3

1.008397

Evaluate changes and additions to meet Good Practices for cultivating and harvesting medicinal herbs and principles and standards for exploiting natural medicinal herbs (GACP)

center

IV

Food safety and nutrition field: 09 administrative procedures at central level; 03 Provincial level administrative procedures

first

2.001024

Register a declaration of domestically produced products for medical nutritional foods, foods for special diets, and nutritional products for children up to 36 months old (in the case of organizations and individuals). selected according to the provisions of Point C, Clause 1, Article 8 of Decree No. 15/2018/ND-CP dated February 2, 2018 of the Government).

Food safety and nutrition

center

2

1.001872

Register imported product declaration for medical nutritional foods, foods for special diets, nutritional products for children up to 36 months of age (in case organizations or individuals choose to according to the provisions of Point C, Clause 1, Article 8, Decree No. 15/2018/ND-CP dated February 2, 2018 of the Government)

center

3

1.001422

Register a domestically produced product declaration for health protection foods, mixed food additives with new uses, food additives not on the list of additives allowed to be used in food, or not for the intended users as prescribed by the Ministry of Health

center

4

1.001411

Register imported product declaration for health protection foods, mixed food additives with new uses, food additives that are not on the list of additives allowed to be used in food or are incorrect. Users are regulated by the Ministry of Health

center

5

2.001017

Confirmation of advertising content for medical nutritional products, foods for special diets, and nutritional products for children up to 36 months of age (in case organizations or individuals choose to submit applications). Application for registration of product announcement to the Ministry of Health according to the provisions of Clause 1, Article 27 of Decree 15/2018/ND-CP).

center

6

1.006424

Register advertising content for health protection foods

center

7

1.002484

Issuing certificates of free sale (CFS) for exported food products under the management of the Ministry of Health

center

8

1.000089

Issuing health certificates (HC) for foods, food additives, and processing aids; tools, packaging materials, and food containers

center

9

2.000008

Exemption from inspection and supervision for food testing facilities that have been legally accredited by a Vietnamese accreditation organization or a foreign accreditation organization that is a member of the mutual agreement of the International Laboratory Accreditation Association, Asia-Pacific Laboratory Accreditation Association evaluates and issues accreditation certificates according to National Standard TCVN ISO/IEC 17025:2007 or International Standard ISO/IEC 17025:2005

center

ten

1.003108

Register advertising content for medical nutritional products, foods for special diets, nutritional products for children up to 36 months old

Conscious

11

1.003332

Register domestically produced product declaration for medical nutritional foods, foods for special diets, nutritional products for children up to 36 months old

Conscious

twelfth

1.003348

Register imported product declaration for medical nutritional foods, foods for special diets, nutritional products for children up to 36 months old

Conscious

V

Field of medical equipment and constructions: 15 administrative procedures at central level; 03 Provincial level administrative procedures

first

1.010541

Urgent issuance of new circulation numbers for type C and D medical equipment to serve disease prevention and control, overcoming the consequences of natural disasters and disasters in urgent cases

Medical equipment and works

center

2

1.002155

New issuance of circulation numbers for medical equipment of types C and D in the case of rapid issuance

center

3

1.003925

New issuance of circulation numbers for medical devices of types C and D that have corresponding national technical regulations

center

4

1.002949

Issuance of new circulation numbers for medical equipment of types C and D that are measuring devices that require sample approval according to the provisions of law on measurement

center

5

1.002402

Issue new circulation numbers for other medical devices of types C and D

center

6

1.003844

Issuance of medical equipment import license

center

7

1.002991

Issue Certificate of Free Circulation (CFS) for medical devices

center

8

1.002151

Issuance of Certificate of registration of medical equipment inspection activities

center

9

1.002301

Re-issue of Certificate of registration for medical equipment inspection activities

center

ten

1.002294

Issuing and amending the Certificate of registration of medical equipment inspection activities

center

11

1.002971

Continue to circulate medical equipment in case the medical equipment owner does not continue production or goes bankrupt or dissolves.

center

twelfth

1.010229

Issuing circulation registration certificates for type C and D medical equipment to serve the prevention and control of COVID-19 epidemic in urgent cases

center

13

1.010228

Announcement of applicable standards for type B medical equipment for COVID-19 epidemic prevention and control in urgent cases

center

14

1.002981

Declaration of eligibility to consult on medical device techniques

center

15

1.010542

Announcing the concentration and content in raw materials for medical equipment production, foreign control substances containing narcotics and precursors.

center

16

1.003039

Announcement of eligibility to purchase and sell medical equipment of types B, C, D

Conscious

17

1.003006

Declaration of eligibility to produce medical equipment

Conscious

18

1.003029

Announcement of standards applicable to medical equipment of type A and B

Conscious

BECAUSE

Field of training and scientific research: 01 administrative procedure at central level

first

1.002319

Register for clinical drug trial research

Training and scientific research

center

VII

Field of medical examination and treatment: 02 administrative procedures at central level

first

1.002587

Issuance of certificates of advertising content for medical examination and treatment services falls under the authority of the Ministry of Health

Medical examination and treatment

center

2

1.001377

Re-issuance of confirmation of advertising content for medical examination and treatment services under the authority of the Ministry of Health in case of loss or damage

center