Әділет
Әділет

On fixation of prices for services implemented by a state monopoly entity

Invalidated Unofficial translation

Order of the Minister of Health of the Republic of Kazakhstan dated August 31, 2017 No. 671. It was registered with the Ministry of Justice of the Republic of Kazakhstan on November 21, 2017 No. 16002. Abolished by the order of the Acting Minister of Health of the Republic of Kazakhstan dated January 20, 2021 No. KR DSM-7

      Unofficial translation

      Footnote. Abolished by the order of the Acting Minister of Health of the Republic of Kazakhstan dated January 20, 2021 No. KR DSM-7 (effective ten calendar days after the date of its first official publication).

      In compliance with paragraph 2 of Article 63 and paragraph 2 of Article 63-1 of the Code of the Republic of Kazakhstan of September 18, 2009 "On Public Health and Healthcare System " I DO HEREBY ORDER:

      1. Establish:

      1) prices for services sold by the subject of the state monopoly for the examination during state registration, re-registration and amendments to the registration dossier of medicines and medical devices in accordance with the Rules for registration and examination of safety, quality and effectiveness of medical devices approved by the decision of the Eurasian Economic Commission of February 12, 2016 No. 46 and the Rules for registration and examination of medicinal products for medical use, approved by the decision of the Eurasian Economic Commission of November 3, 2016 No. 78, in accordance with Appendix 1 to this order;

      2) prices for services sold by a state monopoly entity for conducting an examination during state registration, re-registration and amendments to the registration dossier of drugs and medical devices in accordance with the legislation of the Republic of Kazakhstan, in accordance with Appendix 2 to this order;

      3) prices for services sold by a state monopoly entity for assessing the safety and quality of medicines and medical devices registered in the Republic of Kazakhstan, in accordance with Appendix 3 to this order.

      Footnote. Clause 1 as amended by the order of the Minister of Health of the Republic of Kazakhstan dated September 30, 2019 No. ҚР DSM-130 (shall be enforced upon expiry of ten calendar days after the day of its first official publication.

      2. In the manner prescribed by the law, the Department for Public Procurement and Assets of the Ministry of Healthcare of the Republic of Kazakhstan, shall ensure:

      1) state registration of this Order with the Ministry of Justice of the Republic of Kazakhstan;

      2) within ten calendar days from the date of the state registration of this order, sending a copy hereof in paper and electronic form in the state and Russian languages ​​to Republican State Enterprise on the Right of Economic Management “Republican Center of Legal Information of the Ministry of Justice of the Republic of Kazakhstan” for official publication and inclusion in the Reference Control Bank of Regulatory Legal Acts of the Republic of Kazakhstan, as well as sending a copy hereof for official publication in printed periodical publications;

      3) placement of this order on the official Internet resource of the Ministry of Healthcare of the Republic of Kazakhstan;

      4) within ten working days after the state registration of this order with the Ministry of Justice of the Republic of Kazakhstan, submission to the Department of Legal Services of the Ministry of Healthcare of the Republic of Kazakhstan of information on the implementation of measures provided for in subparagraphs 1), 2) and 3) of this paragraph.

      3. Order of the Minister of Health and Social Development of the Republic of Kazakhstan No. 771 dated September 30, 2015 “On Approval of Prices for Services Implemented by a State Monopoly Entity on Conducting Expert Examination during State Registration, Re-registration and Introduction of Amendments to the Registration Dossier of Medicines, Medical Devices and Medical Equipment and the Assessment of the Safety and Quality of Medicines and Medical Devices Registered in the Republic of Kazakhstan”, (registered in the Register of State Registration of Regulatory Legal Acts under No. 12179, published in Legal Information System“ Adilet ”on October 22, 2015) shall be deemed to have lost force.

      4. The control over the execution of this order shall be assigned to Vice Minister of Healthcare of the Republic of Kazakhstan Tsoi A. V.

      5. This order shall become effective ten calendar days after the day of its first official publication.

      Minister of Healthcare
      of the Republic of Kazakhstan Y. Birtanov

      "AGREED"

      Minister of National Economy

      of the Republic of Kazakhstan

      _____________T. Suleimenov

      October 27, 2017

  Appendix 1
to the order of the Minister
health care
Republic of Kazakhstan
dated August 31, 2017 No. 671

Prices for services sold by the subject of the state monopoly for the examination during state
registration, re-registration and amendments to the registration dossier of medicines and
medical devices in accordance with the Rules for registration and examination of the safety,
quality and effectiveness of medical devices, approved by the decision of the Eurasian
Economic Commission of February 12 2016 No. 46 and the Rules for registration and
examination of medicines for medical use, approved by the decision of the
Eurasian Economic Commission of November 3, 2016 No. 78

      Footnote. Appendix 1 as amended by order of the Minister of Health of the Republic of Kazakhstan dated September 30, 2019 No. ҚR DSM-130 (shall be enforced upon expiry of ten calendar days after the day of its first official publication).

No.

Name of works

unit of measurement

Price in tenge without value added tax

1

2

3

4

Expertise during state registration, re-registration and amendments to the registration dossier of medicines, medical devices, in accordance with the Rules for registration and expertise of safety, quality and effectiveness of medical devices, approved by the decision of the Eurasian Economic Commission dated February 12, 2016 No. 46 and the Rules for registration and expertise medicines for medical use, approved by the decision of the Eurasian Economic Commission of November 3, 2016 No. 78 (as a reference state and a state of recognition)

1.1. Expertise in registration of medicines

1

Original one-component drug

1 drug

1 579 541  

1.1

In addition to each dose

1 medicinal dose

1 465 769  

2

Original multicomponent drug

1 drug

1 702 488  

2.1

In addition to each dose

1 medicinal dose

1 394 870  

3

Original biological one-component drug

1 drug

1 671 615  

3.1

In addition to each dose

1 medicinal dose

1 573 052  

4

Original biological multicomponent drug

1 drug

1 772 301  

4.1

In addition to each dose

1 medicinal dose

1 676 228  

5

Reproduced one-component drug

1 drug

1 344 801  

5.1

additionally each dose

1 medicinal dose

1 221 583  

6

Reproduced multicomponent drug

1 drug

1 652 951  

6.1

In addition to each dose

1 medicinal dose

1 419 127  

7

Biosimilar single-component drug ( Biosimilar )

1 drug

1 552 514  

7.1

In addition to each dose

1 medicinal dose

1 466 365  

8

Biosimilar multicomponent drug ( Biosimilar )

1 drug

1 617 683  

8.1

In addition to each dose

1 medicinal dose

1 545 254  

9

Hybrid single-component drug

1 drug

1 302 132  

9.1

In addition to each dose

1 medicinal dose

1 173 672  

10

Hybrid multicomponent drug

1 drug

1 675 144  

10.1

In addition to each dose

1 medicinal dose

1 420 957  

11

Radiopharmaceutical Drug - Kit

1 drug

1 260 737  

12

Radiopharmaceutical drug - precursor

1 drug

1 123 568  

13

Homeopathic Medicine - Base Rate

1 drug

679 680 

13.1

In addition to each dose

1 medicinal dose

631 674 

14

Herbal Medicinal Product - Base Rate

1 drug

863 314 

14.1

In addition to each dose

1 medicinal dose

788 373 

15

Medicinal herbal raw materials - base rate

1 drug

827 694 

1.2. Expertise during re-registration of medicinal products (confirmation of registration, bringing the registration dossier in accordance with the requirements of international treaties and acts constituting the law of the Eurasian Economic Union)

16

Original one-component drug

1 drug

693346

16.1

In addition to each dose

1 medicinal dose

661,808

17

Original multicomponent drug

1 drug

757,022

17.1

In addition to each dose

1 medicinal dose

725 302

18

Original biological one-component drug

1 drug

734 662

18.1

In addition to each dose

1 medicinal dose

702,750

19

Original biological multicomponent drug

1 drug

917 840

19.1

In addition to each dose

1 medicinal dose

901,505

20

Reproduced one-component drug

1 drug

599349

20.1

In addition to each dose

1 medicinal dose

562746

21

Reproduced multicomponent drug

1 drug

801,307

21.1

In addition to each dose

1 medicinal dose

786 234

22

Biosimilar single-component drug ( Biosimilar )

1 drug

855 233

22.1

In addition to each dose

1 medicinal dose

837 730

23

Biosimilar multicomponent drug ( Biosimilar )

1 drug

877 224

23.1

In addition to each dose

1 medicinal dose

787 263

24

Hybrid single-component drug

1 drug

788169

24.1

In addition to each dose

1 medicinal dose

733,099

25

Hybrid multicomponent drug

1 drug

801,745

25.1

In addition to each dose

1 medicinal dose

782636

26

Radiopharmaceutical Drug - Kit

1 drug

794,009

27

Radiopharmaceutical drug - precursor

1 drug

749 692

28

Homeopathic Medicine - Base Rate

1 drug

581,161

28.1

In addition to each dose

1 medicinal dose

555 351

29

Herbal Medicinal Product - Base Rate

1 drug

630 238

29.1

In addition to each dose

1 medicinal dose

579,441

30

Medicinal herbal raw materials - base rate

1 drug

626,767

1.3. Expertise when making changes to the registration dossier of medicines

31

Expertise when making changes to the registration dossier of medicinal products, without analytical expertise Type 1A

1 drug

126 954 

32

Expertise when making changes to the registration dossier of medicinal products with analytical expertise Type 1B

1 drug

976 841

33

Expertise when making changes to the registration dossier of medicinal products, without analytical expertise Type 1B

1 drug

510,910

34

Expertise when making changes to the registration dossier of medicinal products with Type II analytical expertise

1 drug

1 135 006

35

Expertise when making changes to the registration dossier of medicinal products, without Type II analytical expertise

1 drug

651539

1.4. Expertise during registration (re-registration) of medical devices

36

Class 1 - basic

1 product

308 335 

37

Class 2A - basic rate

1 product

355 360

38

Class 2B - basic rate

1 product

396,928

39

Class 3 - basic rate

1 product

457,219

1.5. Laboratory tests (analytical expertise) during registration / re-registration of medical devices in accordance with the Rules for registration and expertise of safety, quality and effectiveness of medical devices, approved by the decision of the Eurasian Economic Commission dated February 12, 2016 No. 46 and the Rules for registration and expertise of medicines for medical use, approved by the decision of the Eurasian Economic Commission of November 3, 2016 No. 78

40

Class 1 - basic

1 product

264 213 

40.1

Additionally for each modification

1 product

193 211

41

Class 2A - basic rate

1 product

371,027

41.1

Additionally for each modification

1 product

213,716

42

Class 2B - basic rate

1 product

405 693

42.1

Additionally for each modification

1 product

252 320

43

Class 3 - basic rate

1 product

519,780

43.1

Additionally for each modification

1 product

281521

1.6. Expertise when making changes to the registration dossier of medical devices

44

Expertise when making changes to the registration dossier of a medical device

1 product

346,083

  Appendix 2
to the order of the Minister of
Health of the
Republic of Kazakhstan
dated August 31, 2017 No. 671

Prices for services sold by the subject of the state monopoly for the examination during state
registration, re-registration and amendments to the registration dossier of medicines and
medical devices in accordance with the legislation of the Republic of Kazakhstan

      Footnote. Appendix 2 as amended by order of the Minister of Health of the Republic of Kazakhstan dated September 30, 2019 No. ҚР DSM-130 (shall be enforced upon expiry of ten calendar days after the day of its first official publication).


No.

Name of works

unit of measurement

Price in tenge without value added tax

1

2

3

4

1. Expertise during state registration, re-registration and amendments to the registration dossier of medicines and medical devices imported into the Republic of Kazakhstan

1.1. Expertise for state registration of medicines

1

Multicomponent drug

1 drug

1 401 552

1.1

In addition to each dosage

1 medicinal dose

1 121 196

1.2

In addition to each packing

1 packing

29632

2

Multicomponent drug - bulk product

1 drug

1 350 891

2.1

In addition to each drug dose - bulk product

1 medicinal dose

1 095 386

3

One-component drug

1 drug

748,079

3.1

In addition to each dosage

1 medicinal dose

590 192

3.2

In addition to each packing

1 packing

14840

4

One-component drug - bulk product

1 drug

711 181

4.1

In addition to each drug dose - bulk product

1 medicinal dose

571,600

5

Medical multicomponent immunobiological preparation, Biosimilars

1 drug

1 648 097

5.1

In addition to each dosage

1 medicinal dose

1 272 695

5.2

In addition to each packing

1 packing

30,039

6

Medical multicomponent immunobiological preparation, Biosimilars - bulk product

1 drug

1 567 382

6.1

In addition to each drug dose - bulk product

1 medicinal dose

1 231 160

7

Medical one-component immunobiological preparation, Biosimilars

1 drug

1 234 878

7.1

In addition to each dosage

1 medicinal dose

993,047

7.2

In addition to each packing

1 packing

15208

8

Medical one-component immunobiological preparation, Biosimilars - bulk product

1 drug

1 161 950

8.1

In addition to each drug dose - bulk product

1 medicinal dose

956 600

9

Homeopathic remedy and herbal medicine

1 drug

323,762

9.1

In addition to each dosage

1 medicinal dose

275,088

10

Homeopathic remedy and herbal medicine -  bulk product

1 drug

301 307

10.1

In addition to each drug dose - bulk product

1 medicinal dose

264 397

11

Substances not manufactured in GMP conditions ( giempi ) *, Premixes

1 substance

396,031

12

Medicinal plant raw materials

1 drug

315510

13

Parapharmaceuticals

1 drug

183 795

1.2. Expertise in the state re-registration of medicines

14

Multicomponent drug

1 drug

1 266 959

14.1

In addition to each dosage

1 medicinal dose

929580

14.2

In addition to each packing

1 packing

19263

15

Multicomponent drug - bulk product

1 drug

1 233 180

15.1

In addition to each drug dose - bulk product

1 medicinal dose

912 352

16

One-component drug

1 drug

555 610

16.1

In addition to each dosage

1 medicinal dose

444,248

16.2

In addition to each packing

1 packing

9897

17

One-component drug - bulk product

1 drug

531,014

17.1

In addition to each drug dose - bulk product

1 medicinal dose

431,855

18

Medical multicomponent immunobiological preparation, Biosimilars

1 drug

1 224 339

18.1

In addition to each dosage

1 medicinal dose

1 062 538

18.2

In addition to each packing

1 packing

20,024

19

Medical multicomponent immunobiological preparation, Biosimilars - bulk product

1 drug

1 170 527

19.1

In addition to each drug dose - bulk product

1 medicinal dose

1 034 858

20

Medical one-component immunobiological preparation, Biosimilars

1 drug

1 003 929

20.1

In addition to each dosage

1 medicinal dose

882,980

20.2

In addition to each packing

1 packing

10145

21

Medical one-component immunobiological preparation, Biosimilars - bulk product

1 drug

955 316

21.1

In addition to each drug dose - bulk product

1 medicinal dose

858684

22

Homeopathic remedy and herbal medicine

1 drug

269257

22.1

In addition to each dosage

1 medicinal dose

223,595

23

Homeopathic remedy and herbal medicine - bulk product

1 drug

254,272

23.1

In addition to each drug dose - bulk product

1 medicinal dose

216,457

24

Substances not manufactured in GMP conditions ( giempy ), Premixes

1 substance

353,189

25

Medicinal plant raw materials

1 drug

239,933

26

Parapharmaceuticals

1 drug

154343

1.3. Expertise when making changes to the registration dossier of medicines

27

Expert work when making changes to the registration dossier, with analytical expertise

1 view

194128

28

Expert work when making changes to the registration dossier, without analytical expertise

1 view

111 220

1.4. Expert work during registration (re-registration) of medical devices

29

bracket -system

1 product

6,028

Modification of the bracket -system

1 product

6 028

30

Hemocontainers ,
hemofilters ,
leukofilters ,
hemoconcentrators

1 product

408 601

Modification of hemocontainers ,
hemofilters ,
leukofilters ,
hemoconcentrators

1 product

188 330

31

Medical needles (except for surgical needles)

1 product

135,578

Modification of medical needles (except for surgical needles)

1 product

5998

32

Products for dentistry (excluding implantable)

1 product

48905

Modification of products for dentistry (except for implantable)

1 product

25672

33

Medical devices intended for use in dialysis procedures, patient life support systems, and anesthesia machines

1 product

270,306

Modification of medical devices intended for use in dialysis procedures, patient life support systems and anesthesia machines

1 product

45964

34

Prosthetic and orthopedic products

1 product

43770

Modification of prosthetic and orthopedic products

1 product

11,962

35

Products used for transfusion, perfusion and infusion , vascular catheters

1 product

257,174

Modification of products used for transfusions, perfusions and infusions , vascular catheters

1 product

33804

36

Medical products in the form of solutions, drops, sprays, gels, ointments, tablets, creams

1 product

303 448

Modification of medical devices in the form of solutions, drops, sprays, gels, ointments, tablets, creams

1 product

114194

37

Medical devices for in vitro (in vitro ) ** diagnostics

1 product

97123

Modification of medical devices for in vitro (in vitro ) diagnostics

1 product

83 121

38

Medical devices for in vitro (in vitro ) diagnostics, a set of up to 10 items

1 set

56,027

Modification of medical devices for in vitro (in vitro ) diagnostics, a set of up to 10 items

1 set

50 127

39

Medical devices for in vitro (in vitro ) diagnostics, a set of 11 to 20 items

1 set

98803

Modification of medical devices for in vitro (in vitro ) diagnostics, a set of 11 to 20 items

1 set

90934

40

Medical devices for in vitro (in vitro ) diagnostics, a set of over 20 items

1 set

154012

Modification of medical devices for in vitro (in vitro ) diagnostics, a set of over 20 items

1 set

131,365

41

Medical devices for birth control and protection against sexually transmitted infections

1 product

107,899

Modification of medical devices for birth control and protection against sexually transmitted infections

1 product

16361

42

Medical devices for in vitro fertilization service

1 product

213829

Modification of medical devices for in vitro fertilization service

1 product

34 482

43

Reusable sanitary and hygienic products

1 product

67,041

Modification of reusable sanitary and hygienic products

1 product

36416

44

Disposable sanitary and hygienic medical products

1 product

99,503

Modification of disposable medical products for sanitary and hygienic purposes

1 product

35,264

45

Medical devices for special purposes

1 product

426,040

Modification of medical devices for special purposes

1 product

8 008

46

Medical devices used for functional diagnostics

1 product

8 465

Modification of medical devices used for functional diagnostics

1 product

5745

47

Implantable devices

1 product

421,975

Modification of implantable devices

1 product

95571

48

Special purpose catheters

1 product

128,567

Modification of special purpose catheters

1 product

25705

49

Sets and sets of medical instruments (up to 50 components)

1 set

158,557

Modification of kits and sets of medical instruments (up to 50 components)

1 set

22,097

50

Kits and sets of medical instruments (from 101 to 500 components)

1 set

236,429

Modification of kits and sets of medical instruments (from 101 to 500 components)

1 set

47458

51

Kits and sets of medical instruments (from 501 to 1000 components)

1 set

303,689

Modification of kits and sets of medical instruments (from 501 to 1000 components)

1 set

82062

52

Kits and sets of medical instruments (from 51 to 100 components)

1 set

207,990

Modification of kits and sets of medical instruments (from 51 to 100 components)

1 set

43302

53

Sets and sets of medical instruments (over 1000 components)

1 set

372,479

Modification of kits and sets of medical instruments (over 1000 components)

1 set

132,763

54

Contact lenses

1 product

150 300

Contact lenses modification

1 product

5608

55

Spectacle lenses

1 product

7 720

Spectacle lens modification

1 product

4991

56

Medical instruments

1 product

82822

Modification of medical instruments

1 product

3821

57

Medical linen, means of protection of skin and mucous membranes

1 product

86898

Modification of medical underwear, means of protection of the skin and mucous membranes

1 product

37,044

58

Medical underwear, means of protection of skin and mucous membranes, sets

1 product

98696

Modification of medical underwear, means of protection of skin and mucous membranes, sets

1 product

64248

59

Dental kits (up to 10 pieces)

1 set

44 325


Modification of sets of dental materials (up to 10 components)

1 set

20484

60

Sets of dental materials (over 10 components)

1 set

59 587

Modification of sets of dental materials (over 10 components)

1 set

28,003

61

Natural dressings

1 product

115659

Modification of natural-based dressings

1 product

39559

62

Polymer-based dressings

1 product

85,907

Modification of polymer-based dressings

1 product

11503

63

Medicated dressings

1 product

172,764

Modification of dressings with the addition of drugs

1 product

83,995

64

Plasters

1 product

79631

Modification of plasters

1 product

10 783

65

Medicinal patches

1 product

117,631

Modification of drug patches

1 product

60387

66

Fixing dressings, including contoured and elastic, tourniquets

1 product

42 586

Modification of fixing bandages, including contour and elastic bandages

1 product

23309

67

Consumables for taking blood samples, urine, stool, biopsy material

1 product

163349

Modification of consumables for sampling blood, urine, stool, biopsy material

1 product

94 381

68

Dental materials

1 product

50 788

Modification of dental materials

1 product

21368

69

Suture material

1 product

235,709

Suture modification

1 product

34190

70

Medical syringes

1 product

100 473

Modification of medical syringes

1 product

20744

1.5. Expertise when making changes (type 1) to the registration dossier of medical devices

71

Making changes (type 1) to the registration dossier of medical devices, without analytical expertise

1 view

62,009

Modification when making changes (type 1) to the registration dossier of medical devices, without analytical expertise

1 view

62,009

72

Making changes (type 1) to the registration dossier of medical devices, with analytical expertise

1 view

132,400

Modification when making changes (type 1) to the registration dossier of medical devices, with analytical expertise

1 view

97436

1.6. Expert work in registration and re-registration of medical devices (medical equipment)

73

Medical device (Medical equipment) - safety class 1 and 2a - registration

1 view

140864

Re-registration

1 view

70497

74

Medical device (Medical equipment) - safety class 2 b and 3 - registration

1 view

343 850

Re-registration

1 view

172,283

75

Medical complexes - registration

1 view

515 789

Re-registration

1 view

257 807

1.7. Expert work when making changes (type 1) to the registration dossier of a medical device (medical equipment)

76

Making changes (type 1) to the registration dossier of a medical device (medical equipment), without analytical expertise

1 view

62,009

2. Expertise during state registration, re-registration and amendments to the registration dossier of medicines and medical devices for domestic manufacturers

2.1. Expertise in registration of medicines

77

Multicomponent drug

1 drug

235,574

77.1

In addition to each dosage

1 medicinal dose

154 818

77.2

In addition to each packing

1 packing

5738

78

Multicomponent drug - bulk product

1 drug

235,574

78.1

In addition to each drug dose - bulk product

1 medicinal dose

154 818

79

One-component drug

1 drug

190 956

79.1

In addition to each dosage

1 medicinal dose

117,038

79.2

In addition to each packing

1 packing

3468

80

One-component drug - bulk product

1 drug

190 956

80.1

In addition to each drug dose - bulk product

1 medicinal dose

117,038

81

Medical multicomponent immunobiological preparation, biosimilars

1 drug

199,400

81.1

In addition to each dosage

1 medicinal dose

121 520

81.2

In addition to each packing

1 packing

5738

82

Medical multicomponent immunobiological preparation, biosimilars - bulk product

1 drug

199 400

82.1

In addition to each drug dose - bulk product

1 medicinal dose

121 520

83

Medical one-component immunobiological preparation, biosimilars

1 drug

199,400

83.1

In addition to each dosage

1 medicinal dose

121 520

83.2

In addition to each packing

1 packing

3468

84

Medical one-component immunobiological preparation, biosimilars - bulk product

1 drug

199 400

84.1

In addition to each drug dose - bulk product

1 medicinal dose

121 520

85

Homeopathic remedy and herbal medicine

1 drug

179 756

85.1

In addition to each dosage

1 medicinal dose

126 046

86

Homeopathic remedy and herbal medicine - bulk product

1 drug

179 756

86.1

In addition to each drug dose - bulk product

1 medicinal dose

126 046

87

Substances not manufactured under conditions ( giempie ), premixes

1 substance

126 014

88

Medicinal plant raw materials

1 drug

36 102

89

Parapharmaceuticals

1 drug

215 550

2.2. Expertise in the state re-registration of medicines

90

Multicomponent drug

1 drug

209 692

90.1

In addition to each dosage

1 medicinal dose

138 644

90.2

In addition to each packing

1 packing

2546

91

Multicomponent drug - bulk product

1 drug

209,692

91.1

In addition to each drug dose - bulk product

1 medicinal dose

138644

92

One-component drug

1 drug

172,654

92.1

In addition to each dosage

1 medicinal dose

114 326

92.2

In addition to each packing

1 packing

2924

93

One-component drug - bulk product

1 drug

172,654

93.1

In addition to each drug dose - bulk product

1 medicinal dose

114 326

94

Medical multicomponent immunobiological preparation, biosimilars

1 drug

181862

94.1

In addition to each dosage

1 medicinal dose

116,074

94.2

In addition to each packing

1 packing

2546

95

Medical multicomponent immunobiological preparation, biosimilars - bulk product

1 drug

181862

95.1

In addition to each drug dose - bulk product

1 medicinal dose

116 074

96

Medical one-component immunobiological preparation, biosimilars

1 drug

181862

96.1

In addition to each dosage

1 medicinal dose

116 074

96.2

In addition to each packing

1 packing

2 924

97

Medical one-component immunobiological preparation, biosimilars - bulk product

1 drug

181 862

97.1

In addition to each drug dose - bulk product

1 medicinal dose

116 074

98

Homeopathic remedy and herbal medicine

1 drug

174618

98.1

In addition to each dosage

1 medicinal dose

123 866

99

Homeopathic remedy and herbal medicine - bulk product

1 drug

174618

99.1

In addition to each drug dose - bulk product

1 medicinal dose

123 866

100

Substances not manufactured in GMP conditions ( giempi ), Premixes

1 substance

123,776

101

Medicinal plant raw materials

1 drug

26200

102

Parapharmaceuticals

1 drug

195,016

2.3. Expertise when making changes (type 1) to the registration dossier of medicines

103

Expertise when making changes (type 1) to the registration dossier, with analytical expertise

1 view

32748

104

Expertise when making changes (type 1) to the registration dossier, without analytical expertise

1 view

32748

2.4. Expertise for registration of medical devices ***


105

bracket -system

1 product

39956


Modification of braces systems

1 product

6,665


106

Hemocontainers , hemofilters , leuco filters , hemoconcentrators

1 product

190 314


Modification hemocontainers , hemofilter , leuco filters hemoconcentrators

1 product

190314


107

Medical needles (except for surgical needles)

1 product

39956


Modification of medical needles (except for surgical needles)

1 product

6608


108

Products for dentistry (excluding implantable)

1 product

39 956


Modification of products for dentistry (except for implantable)

1 product

28 383


109

Medical devices intended for use in dialysis procedures, patient life support systems, and anesthesia machines

1 product

79 994


Modification of medical devices intended for use in dialysis procedures, patient life support systems and anesthesia machines

1 product

50 781


110

Prosthetic and orthopedic products

1 product

69166


Modification of prosthetic and orthopedic products

1 product

13,227


111

Products used for transfusion, perfusion and infusion , vascular catheters

1 product

79,994



Modification of products used for transfusions, perfusions and infusions , vascular catheters

1 product

37355


112

Medical products in the form of solutions, drops, sprays, gels, ointments, tablets, creams

1 product

190 956


Modification of medical devices in the form of solutions, drops, sprays, gels, ointments, tablets, creams

1 product

124 526


113

Medical devices for in vitro (in vitro ) diagnostics

1 product

70 546


Modification of medical devices for in vitro (in vitro ) diagnostics

1 product

70 546


114

Medical devices for in vitro (in vitro ) diagnostics, a set of up to 10 items

1 set

70 546


Modification of medical devices for in vitro (in vitro ) diagnostics, a set of up to 10 items

1 set

55 081


115

Medical devices for in vitro (in vitro ) diagnostics, a set of 11 to 20 items

1 set

70 546


Modification of medical devices for in vitro (in vitro ) diagnostics, a set of 11 to 20 items

1 set

70 546


116

Medical devices for in vitro (in vitro ) diagnostics, a set of over 20 items

1 set

70 546


Modification of medical devices for in vitro (in vitro ) diagnostics, a set of over 20 items

1 set

70 546


117

Medical devices for birth control and protection against sexually transmitted infections

1 product

79 994


Modification of medical devices for birth control and protection against sexually transmitted infections

1 product

18,073


118

Medical devices for in vitro fertilization service

1 product

79,994


Modification of medical devices for in vitro fertilization service

1 product

38 094


119

Medical products for sanitary and hygienic purposes, reusable

1 product

33 270


Modification of reusable medical products for sanitary and hygienic purposes

1 product

33 270


120

Disposable sanitary and hygienic medical products

1 product

33 270



Modification of disposable medical products for sanitary and hygienic purposes

1 product

33 270


121

Medical devices for special purposes

1 product

55,594


Modification of medical devices for special purposes

1 product

8 851


122

Medical devices used for functional diagnostics

1 product

9,360


Modification of medical devices used for functional diagnostics

1 product

6 352


123

Implantable devices

1 product

69166


Modification of implantable devices

1 product

69166


124

Special purpose catheters

1 product

55,594


Modification of special purpose catheters

1 product

28408


125

Sets and sets of medical instruments (up to 50 components)

1 set

190314


Modification of kits and sets of medical instruments (up to 50 components)

1 set

24,425


126

Kits and sets of medical instruments (from 101 to 500 components)

1 set

190314


Modification of kits and sets of medical instruments (from 101 to 500 components)

1 set

52 464


127

Kits and sets of medical instruments (from 501 to 1000 components)

1 set

190314


Modification of kits and sets of medical instruments (from 501 to 1000 components)

1 set

90,724


128

Kits and sets of medical instruments (from 51 to 100 components)

1 set

190314


Modification of kits and sets of medical instruments (from 51 to 100 components)

1 set

47 870


129

Sets and sets of medical instruments (over 1000 components)

1 set

190314


Modification of kits and sets of medical instruments (over 1000 components)

1 set

146,774


130

Contact lenses

1 product

95642


Contact lenses modification

1 product

6,200


131

Spectacle lenses

1 product

95642


Spectacle lens modification

1 product

5 518


132

Medical instruments

1 product

39956


Modification of medical instruments

1 product

4223


133

Medical linen, means of protection of skin and mucous membranes

1 product

79,994


Modification of medical underwear, means of protection of the skin and mucous membranes

1 product

40945


134

Medical underwear, means of protection of skin and mucous membranes, sets

1 product

79,994


Modification of medical underwear, means of protection of skin and mucous membranes, sets

1 product

71,024


135

Dental kits (up to 10 pieces)

1 set

39956


Modification of sets of dental materials (up to 10 components)

1 set

22642


136

Sets of dental materials (over 10 components)

1 set

39956


Modification of sets of dental materials (over 10 components)

1 set

30955


137

Natural dressings

1 product

39956


Modification of natural-based dressings

1 product

39956


138

Polymer-based dressings

1 product

39956


Modification of polymer-based dressings

1 product

12 748


139

Medicated dressings

1 product

39 956


Modification of dressings with the addition of drugs

1 product

39956


140

Plasters

1 product

39 956


Modification of plasters

1 product

11,922


141

Medicinal patches

1 product

39956


Modification of drug patches

1 product

39956


142

Fixing dressings, including contoured and elastic, tourniquets

1 product

39 956


Modification of fixation dressings, including contour and elastic tourniquets

1 product

25 771


143

Consumables for taking blood samples, urine, stool, biopsy material

1 product

55,594


Modification of consumables for sampling blood, urine, stool, biopsy material

1 product

55,594


144

Dental materials

1 product

39956


Modification of dental materials

1 product

23620


145

Suture material

1 product

82382


Suture modification

1 product

37774


146

Medical syringes

1 product

100 306


Modification of medical syringes

1 product

22916


2.5. Expertise when making changes (type 1) to the registration dossier of medical devices


147

Making changes (type 1) to the registration dossier of medical devices, without analytical expertise

1 view

32 748


Modification when making changes (type 1) to the registration dossier of medical devices, without analytical expertise

1 view

32748


148

Making changes (type 1) to the registration dossier of medical devices, with analytical expertise

1 view

32748


Modification when making changes (type 1) to the registration dossier of medical devices, with analytical expertise

1 view

32748

      Note:

      * GMP ( giempi ) - Good Pharmaceutical Practices in the Circulation of Medicines - Health standards that apply to all stages of the life cycle of medicines: good manufacturing practice

      ** in vitro (in vitro ) - studies in which not multicellular whole organisms are used as test systems, but microorganisms or material isolated from whole organisms, or their imitation.

      *** Expertise upon re-registration of medical devices manufactured in the Republic of Kazakhstan (for domestic manufacturers) due to the expiration of the registration certificate is paid in the amount of 50% of the registration cost.

  Appendix 3
to the order of the Minister of
Health of the
Republic of Kazakhstan
dated August 31, 2017 No. 671

Prices for services sold by a state monopoly entity for assessing the safety and quality of
medicines and medical devices registered in the Republic of Kazakhstan

      Footnote. Appendix 3 as amended by order of the Minister of Health of the Republic of Kazakhstan dated September 30, 2019 No. ҚR DSM-130 (shall be enforced upon expiry of ten calendar days after the day of its first official publication).

No.

Service (work) name

unit of measurement

Price in tenge without value added tax

1

2

3

4

1.1. Assessment of the safety and quality of drugs and medical devices by declaration

1

Assessment of the safety and quality of drugs and medical devices by declaration

1 drug / 1 product

10,983


Documentary expertise at:



2

Extension of the validity period of the conclusion on safety and quality without testing

1 conclusion

3969

3

Making a copy of the conclusion on safety and quality

1 copy

219

4

Making a duplicate of the conclusion on safety and quality

1 duplicate

1 438

1.2. Assessment of the safety and quality of medicines and medical devices of each batch (batch)

five

Evaluation of safety and quality of medicinal products of a batch (batch) - multicomponent medicinal product

1 drug

71,545

6

Evaluation of safety and quality of medicinal products of a batch (batch) - one-component medicinal product

1 drug

59555

7

Evaluation of safety and quality of medicinal products of a batch (batch) - multicomponent biological medicinal product

1 drug

97152

eight

Assessment of safety and quality of medicinal products in a batch (batch) - one-component biological medicinal product

1 drug

69899

nine

Assessment of the safety and quality of medicinal products in a batch (batch) - homeopathic medicinal product

1 drug

29868

ten

Evaluation of safety and quality of medicinal products of a batch (batch) - herbal medicinal product

1 drug

33,191

eleven

Evaluation of safety and quality of batch (batch) drugs - bulk- product

1 drug

62,276

12

Assessment of the safety and quality of medicinal products in a batch (batch) - medicinal plant raw materials

1 drug

32244

13

Evaluation of safety and quality of batch (batch) medical devices - Class 1

1 product

55 335

fourteen

Assessment of safety and quality of batch (batch) medical devices - Class 2A

1 product

68175

fifteen

Assessment of safety and quality of medical devices of a batch (batch) - Class 2B

1 product

84 122

sixteen

Evaluation of safety and quality of medical devices batch (batch) - Class 3

1 product

115,967

1.3. Serial assessment of the safety and quality of medicines and medical devices


Assessment of production conditions for:

17

Serial assessment of safety and quality of medicines and medical devices - 1 production workshop

1 examination

480,546


Laboratory tests at:

18

Serial assessment of safety and quality of medicinal products - multicomponent medicinal product

1 drug

59550

nineteen

Serial assessment of safety and quality of medicinal products - single-component medicinal product

1 drug

47560

20

Serial assessment of safety and quality of medicinal products - multicomponent biological medicinal product

1 drug

85156

21

Serial assessment of safety and quality of medicinal products - single-component biological medicinal product

1 drug

57902

22

Serial assessment of safety and quality of medicines - homeopathic medicinal product

1 drug

17873

23

Serial assessment of safety and quality of medicines - herbal medicinal product

1 drug

21196

24

Serial assessment of safety and quality of medicines - bulk -product

1 drug

50281

25

Serial assessment of the safety and quality of medicines - medicinal plant raw materials

1 drug

20249

26

Serial Assessment of Safety and Quality of Medical Devices - Class 1

1 product

43340

27

Serial Assessment of Safety and Quality of Medical Devices - Class 2A

1 product

56180

28

Serial assessment of safety and quality of medical devices - Class 2B

1 product

72127

29

Serial assessment of safety and quality of medical devices - Class 3

1 product

103,972


1.4. Laboratory testing of samples of medicines and medical devices withdrawn from the market

30

Laboratory testing of drug samples withdrawn from the market - multicomponent drug

1 drug

59550

31

Laboratory testing of drug samples withdrawn from the market - one-component drug

1 drug

47560

32

Laboratory testing of drug samples withdrawn from the market - multicomponent biological medicinal product

1 drug

85156

33

Laboratory testing of samples of medicinal products withdrawn from the market - one-component biological medicinal product

1 drug

57902

34

Laboratory testing of drug samples withdrawn from the market - homeopathic medicinal product

1 drug

17873

35

Laboratory testing of drug samples withdrawn from the market - herbal medicinal product

1 drug

21196

36

Laboratory testing of drug samples withdrawn from the market - bulk- product

1 drug

50281

37

Laboratory tests of samples of medicines withdrawn from the market - medicinal plant raw materials

1 drug

20249

38

Laboratory testing of medical device samples taken from the market - Class 1

1 product

43340

39

Laboratory testing of medical device samples taken from the market - Class 2A

1 product

56180

40

Laboratory testing of samples of medical devices withdrawn from the market - Class 2B

1 product

72127

41

Laboratory testing of medical device samples taken from the market - Class 3

1 product

103,972



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