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Cabinet Regulations No.61

Riga, 17 January 2006 (Minutes No.3, §34)

Regulations Regarding Pricelist for Paid Public Services Provided by the State Agency of Medicines

Issued pursuant to The Budgetary and Financial Control Act, Clause 5, Part Nine

1. These Regulations provide a pricelist for paid public services rendered by the State Agency of Medicines.

2. Prices for paid public services provided by the State Agency of Medicines shall be fixed in

accordance with the current pricelist (Annex).

3. Paragraphs 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100 and 103 and Subparagraphs 106.1, 106.2,

and 106.3 of the Annex shall be in effect till 31 December 2010.(As amended by the Cabinet Regulations No.1450 of 15.12.2009)

4. At the request of a medicine registration holder or an applicant for medicine registration, the State

Agency of Medicines is entitled to decide on the submitter’s exemption from the annual fee for post-

registration surveillance of the relevant medicine or veterinary medicine unless the turnover of the said

medicine or veterinary medicine for the previous calendar year exceeded LVL 1500 and provided that

such exemption is necessary to ensure a therapeutic process.(As amended by the Cabinet Regulations No.745 of 15.09.2008)

Prime Minister A.Kalvitis

Healthcare Minister G.Bērziņš

Annex

to Cabinet Regulations No.61

of 17 January 2006

Pricelist for Paid Public Services Rendered by the State Agency of Medicines

# Description of Service Unit

Price excl.

PVN

(LVL)

VAT

(LVL)

Price incl.

VAT(LV

L)

1. Expert’s assessment of an application and the enclosed documentation for registration of medicinal

product by the national procedure*

1.1. Medicinal form submitted for the first time

1.1.1. Medicines containing a new active substance

(except Subparagraphs 1.1.2 and 1.1.3)

Application 10 000.00 0.00 10 000.00

1.1.2. Medicines containing a fixed combination of

known active substances (new medicines

containing at least two active substances,

whose combination has never been earlier

registered as medicines with a constant

formulation), medicines of similar biological

origin or those which are widely used for therapeutic purposes

Application 4 000.00 0.00 4 000.00

1.1.3. Basically similar medicines – generic

medicines, compound registration application

Application 3 000.00 0.00 3 000.00



or other application, except such applications

as mentioned in Subparagraphs 1.4, 1.5, 1.6

and 1.7 hereof

1.2. Each additional medicinal form or substitution

of an active substance with another salt, ester

complex or isomer if their action and safety

characteristics do not differ significantly

Application 2 000.00 0.00 2 000.00

1.3. Each additional strength (concentration) or

commercial packaging of a medicine,

including if substitution of an active substance

with another salt, ester complex or isomer if

their action and safety characteristics do not

differ significantly, for each application

regarding medicines with identical registration

documentation but different names of

medicines and the same or different

registration holder (multiple application), if submitted at the same time

Application 1 000.00 0.00 1 000.00

1.4. Traditionally used phytogenic medicinal

products (phytogenic medicines eligible for a

simplified registration procedure)

1.4.1. containing three or less active substances Application 1 000.00 0.00 1 000.00

1.4.2. containing more than three active substances Application 1 500.00 0.00 1 500.00

1.5. Homeopathic medicines with therapeutic

indications

Application 1 000.00 0.00 1 000.00

1.6. Homeopathic medicines without therapeutic

indications by a simplified registration

procedure

Application 400.00 0.00 400.00

1.7. Anthroposophic medicines, which are

described in officially used pharmacopoeia and

produced using a homeopathic method

Application 400.00 0.00 400.00

2. Expert’s assessment of an application and the enclosed documentation for re-registration of

medicinal product by the national procedure *

2.1. One officinal form (of the medicine) Application 2 000.00 0.00 2 000.00

2.1.1. Each extra form of the medicine Application 1 000.00 0.00 1 000.00

2.1.2. Each additional strength (concentration) or

commercial packaging of a medicine, each

application regarding medicines with identicalregistration documentation but different names

of medicines and the same or different

registration holder (multiple application), if

submitted at the same time

Application 500.00 0.00 500.00



2.2. Traditionally used phytogenic medicines Application 600.00 0.00 600.00


indications

Application 500.00 0.00 500.00


indications (registered by a simplified

registration procedure)

Application 200.00 0.00 200.00

3. Regularly updated safety report expertise of

medicines registered by the national procedure

- for one medicine*

Report 1 000.00 0.00 1 000.00

4. Expertise of documentation of changes in such medicinal products as registered by the national

procedure*

4.1. Minor changes of Type I A One change 100.00 0.00 100.00

4.2. Minor changes of Type I B One change 150.00 0.00 150.00

4.3. Significant changes of Type II requiring an in-

depth evaluation of research documentation

One change 300.00 0.00 300.00

4.4. Significant changes of Type II not requiring an

in-depth evaluation of research documentation

One change 100.00 0.00 100.00

4.5. Significant changes of Type II related with the

change of a registration certificate holder (where the new registration certificate holder

and the existing holder are not one and the

same person)

One change 100.00 0.00 100.00

4.6. Changes in user instructions or marking (not

related to changes in the medicine description)

One change 100.00 0.00 100.00


product by an interstate recognition procedure, where Latvia is a reference state*

5.1. Medicinal form submitted for the first time Application 2 000.00 0.00 2 000.00

5.2. Each extra medicinal form Application 1 200.00 0.00 1 200.00



application regarding medicines with identical

registration documentation but different names




Application 600.00 0.00 600.00

5.4. For procedure (in addition to Subparagraphs

5.1, 5.2 and 5.3)



5.4.1. Initial procedure of interstate recognition Procedure number 5 000.00 0.00 5 000.00

5.4.2. Repeated procedure of interstate recognition Procedure number 3 000.00 0.00 3 000.00


product by a decentralized procedure, where Latvia is a reference state *

6.1. Firstly submitted medicinal form

6.1.1. With a new active substance Application 10 000.00 0.00 10 000.00

6.1.2. With a known active substance, for a fixed

combination, for similar medicines of

biological origin or widely used medicines

Application 4 000.00 0.00 4 000.00

6.1.3. Basically similar medicines – generic

medicines, compound registration application

or other application

Application 3 000.00 0.00 3 000.00

6.2. Each extra medicinal form Application 2 000.00 0.00 2 000.00








Application 1 000.00 0.00 1 000.00

6.4. For procedure (in addition to Subparagraphs

6.1, 6.2 and 6.3 hereof)

Procedure number 9 000.00 0.00 9 000.00

7. Expertise of an application and the enclosed documentation for medicinal product registration by an

interstate recognition procedure, where Latvia is an involved state*

7.1. Medicinal form submitted for the first time Application 2 000,00 0,00 2 000,00

7.1.1. Each extra medicinal form Application 1 000,00 0,00 1 000,00








Application 500,00 0,00 500,00

8. Expertise of an application and the enclosed documentation for medicinal product registration by a

decentralized procedure, where Latvia is an involved state*

8.1. Medicinal form submitted for the first time Application 3 000.00 0.00 3 000.00



8.1.1. Each extra medicinal form Application 2 000.00 0.00 2 000.00






registration holder (multiple application), if submitted at the same time

Application 1 000.00 0.00 1 000.00

9. Expert’s assessment of an application and the enclosed documentation for re-registration of

medicinal product by the interstate recognition procedure and the decentralized procedure, where

Latvia is

9.1. a reference state*

9.1.1. One officinal form (of a medicine) Application 2 000.00 0.00 2 000.00









Application 500.00 0.00 500.00

9.1.4. For procedure (in addition to Subparagraphs9.1.1, 9.1.2 and 9.1.3 hereof)


9.2. an involved member-state*

9.2.1. Firstly submitted medicinal form Application 2 000.00 0.00 2 000.00









Application 500.00 0.00 500.00

10. Regularly updated safety report expertise of medicines registered by an interstate recognition

procedure and a decentralized procedure, where Latvia is a reference state*

10.1. One medicine Report 1 000.00 0.00 1 000.00

10.2. For procedure (in addition to Subparagraph

10.1 hereof)




11. Expertise of documentation of changes in medicines registered by an interstate recognition

procedure and a decentralized procedure*

11.1. Minor changes of Type I A One change 100.00 0.00 100.00

11.2. Minor changes of Type I B One change 150.00 0.00 150.00



One change 300.00 0.00 300.00



One change 100.00 0.00 100.00


change of a registration certificate holder

One change 100.00 0.00 100.00



One change 100.00 0.00 100.00

11.7. For procedure if Latvia is the responsible

(reference) state

11.7.1. Significant changes of Type II requiring an in-

depth scientific evaluation of documentation

One change 600.00 0.00 600.00

11.7.2. Other changes except those mentioned in

Subparagraph 11.7.1 hereof

One change 300.00 0.00 300.00

12. Post-registration surveillance of medicines (per annum)*

12.1. Each registered medicinal form and strength

(concentration), except for the products

mentioned in Paragraph 13 hereof

Registration number 350.00 0.00 350.00

12.2. Traditionally used phytogenic medicines and

medicines used for diagnostic purposes



indications



indications (registered by a simplified

registration procedure) and anthroposophic

medicines


13. Evaluation of a product (e.g. food supplement, cosmetic product, biocide, medical device) with the

aim of deciding on its conformance to the definition of a medicinal product or veterinary product*

13.1. A products, whose documentation evaluation

does not require in-depth scientific expertise

Application 300.00 0.00 300.00

13.2. In-depth scientific expertise of product’s Application 600.00 0.00 600.00



formulation and pharmacologic properties

14. Expertise of application and documentation for

distribution of medicinal products in Latvia

that were imported in parallel and making

amendments*

Expertise 211.87 0.00 211.87

14.1. changes in user instructions of a medicine Expertise 50.00 0.00 50.00

14.2. changes in the marking of a medicine Expertise 50.00 0.00 50.00

14.3. Changes in a document (change of the

registered office of an entrepreneur)

Expertise 50.00 0.00 50.00

15. Expertise of the application and documentation for distribution of unregistered, individually

assigned medicinal products (in such cases as provided for The Pharmacy Act, Clause 10, Paragraph

7, Subparagraph "a")*

15.1. first entry of the medicinal product in a

document

Expertise 0.50 0.00 0.50

15.2. each subsequent entry of medicine in a

document

Expertise 0.50 0.00 0.50

16. Expertise of the application and documentation for distribution of unregistered, individually

assigned medicinal products (in such cases as provided for The Pharmacy Act, Clause 10, Paragraph

7, Subparagraph "b" and "c")*

16.1. first entry of the medicinal product in a

document

Expertise 15.00 0.00 15.00

16.2. each subsequent entry of medicine in a

document

Expertise 4.75 0.00 4.75

17. Expertise of the application and documentation for importing of samples of medicinal products*

17.1. up to five entries of medicine Expertise 5.00 0.00 5.00

17.2. each subsequent entry of medicine Expertise 1.00 0.00 1.00

18. Expertise of the application and the enclosed documentation of a pharmaceutical or veterinary

pharmaceutical enterprise in the following cases*

18.1. Change of the legal status or type of an

entrepreneur or transfer of title for any

constant parts (shares) of the entrepreneur’s

business

Expertise of

documentation of 1

pharmaceutical or

veterinary

pharmaceuticalenterprise

50.00 0.00 50.00

18.2. Replacement of a pharmacy manager,

responsible officials of a wholesaler of

Expertise of

documentation

50.00 0.00 50.00



medicinal or veterinary products, or change of

qualified persons of a manufacturer or

importer of medicines or veterinary medicines,

officials responsible for production of active

pharmaceutical substances or controllable

substances, heads of quality control structural

units or production structural units, officials

responsible for observance of special

requirements to medicinal or veterinary

product manufacturer or importer (as well as

change of surnames)

regarding 1 official

18.3. Change of the name of an entrepreneur’s firm

or a pharmaceutical or veterinary

pharmaceutical enterprise (if different from the

firm’s name)

Expertise of

documentation of 1

pharmaceutical or

veterinary

pharmaceutical

enterprise

50.00 0.00 50.00

18.4. Change of the registered office (legal address)

of an entrepreneur

Expertise of

documentation of 1

pharmaceutical or

veterinary

pharmaceutical

enterprise

50.00 0.00 50.00

18.5. Change of the surname of an individual

entrepreneur

Expertise of

documentation

regarding 1 official

50.00 0.00 50.00

18.6. In view of closing of a pharmacy affiliate or

branch of a wholesaler of medicines or

veterinary medicines

Expertise of

documentation of 1

pharmaceutical or

veterinary

pharmaceutical

enterprise

30.00 0.00 30.00

18.7. In view of suspension of a special permit

(licence) to perform pharmaceutical or

veterinary pharmaceutical activities

Expertise of

documentation of 1

pharmaceutical or

veterinary

pharmaceutical

enterprise

30.00 0.00 30.00

18.8. In view of suspension of operations of a

pharmacy affiliate or a branch of wholesaler of

medicines or veterinary medicines

Expertise of

documentation of 1

pharmaceutical or

veterinary

pharmaceutical

enterprise

30.00 0.00 30.00

18.9. In view of any amendments in the annex to aspecial permit (licence) for pharmaceutical or

veterinary pharmaceutical activity if no

expert’s assessment of pharmaceutical or

veterinary pharmaceutical activities is required

Expertise of documentation of 1

pharmaceutical or

veterinary

pharmaceutical

enterprise

30.00 0.00 30.00



18.10. Amendments to documents and information if

no re-registration of a special permit (licence)

for pharmaceutical or veterinary

pharmaceutical activity is required

Expertise of

documentation of 1

pharmaceutical or

veterinary

pharmaceutical

enterprise

30.00 0.00 30.00

18.11. Renewal of a special permit (licence) for pharmaceutical or veterinary pharmaceutical

operations if no conformity evaluation of the

pharmaceutical or veterinary pharmaceutical

enterprise is required

1 expertise 50.00 0.00 50.00

18.12. Renewal of a special permit (licence) for


operations, or renewal of any special activity

conditions as provided for in the special permit

(licence) for pharmaceutical or veterinary

pharmaceutical operations, or resumption of production or importing of any concrete

medicine or veterinary medicine, if no

conformity evaluation of the pharmaceutical or

veterinary pharmaceutical enterprise is

required

Expertise of

documentation of 1

pharmaceutical or

veterinary

pharmaceutical

enterprise

30.00 0.00 30.00

18.13. Expertise of the documents of a


enterprise if it commences (carries out)

production or importing of raw materials

Expertise of

documentation of 1

pharmaceutical or

veterinary

pharmaceutical

enterprise

30.00 0.00 30.00

19. Evaluation of documentation for commencement of pharmacy’s operations, commencement of

pharmaceutical operations at a new location (in new premises), commencement of observance of a

new special operation prerequisite and operation procedure documentation (certifications)*

19.1. Drugstores (pharmacies) of general type

19.1.1. If a pharmacy is located within an urban

territory (in a city)

Expertise of

documentation of 1

pharmacy

100.00 0.00 100.00

19.1.2. If a pharmacy is located in a city (town) and

has one affiliate

Expertise of

documentation of 1

pharmacy and its

affiliate

80.00 0.00 80.00

19.1.3. If a pharmacy is located in a city (town) and

has two affiliates

Expertise of

documentation of 1

pharmacy and 2

affiliates

70.00 0.00 70.00

19.1.4. If a pharmacy is located in the country (rural

territory)

Expertise of

documentation of 1

pharmacy

50.00 0.00 50.00



19.1.5. If a pharmacy is located in the country and

has one affiliate

Expertise of

documentation of 1

pharmacy

40.00 0.00 40.00

19.1.6. If a pharmacy is located in the country and

has two affiliates

Expertise of

documentation of 1

pharmacy

35.00 0.00 35.00

19.2. Pharmacy of closed type Expertise of

documentation of 1

pharmacy and its

affiliates

45.00 0.00 45.00

19.3. One pharmacy affiliate if no conformity

evaluation of the pharmacy is required

Expertise of

documentation of 1

affiliate

35.00 0.00 35.00

21. Appraisal of conformity of a pharmaceutical company (wholesaler or manufacture of medicinal

products)*

21.1. Manufacturer or importer of medicinal

products

Expertise of the

documentation of 1

manufacturer or

importer of medicinal

products

400,00 0,00 400,00

21.2. Manufacturer of medicinal products Expertise of the

documentation of 1

manufacturer of

medicinal products

300,00 0,00 300,00

21.3. Manufacturer of medicinal products (partial

production process)

Expertise of the

documentation of 1manufacturer of

medicinal products

300,00 0,00 300,00

21.4. Company only producing medicinal products

for trial

Expertise of the

documentation of 1

manufacturer of

medicinal products

200,00 0,00 200,00

21.5. Wholesaler of medicinal products Expertise of the

documentation of 1

wholesaler

300,00 0,00 300,00

21.6. Department of a wholesaler of medicinal

products

Expertise of the

documentation of 1wholesaler department

70,00 0,00 70,00

21.7. Manufacturer of active substances or

controllable medicines

Expertise of the

documentation of 1

manufacturer

300,00 0,00 300,00

21.8. Company engaged in ethyl alcohol filling

(packing) only

Expertise of the

documentation of 1

manufacturer or

wholesaler of

medicinal products

200,00 0,00 200,00"

23. Preparation & printing of ordered materials 1 page 0,85 0,18 1,0335. Reviewing of an application for a clinical

reserach of medicinal products and the

enclosed documentation*

1 expertise 1 000,00 0,00 1 000,00

35.1 Appraisal of conformity to the good clinical practice for a clinical research centre or a clinical



research-related institution in a country belonging to the European Economic Area in connection

with medicinal product certificate submission for re-registration of the medicinal product*

35.1 1.

One day (one inspector)

1 clinical research

centre/ related

institutiton

246,00 0,00 246,00

35.1 2.

Two days (one inspector)

1 clinical research

centre/ related

institutiton

312,00 0,00 312,00

35.1 3.

Three days (one inspector)

1 clinical research

centre/ related

institutiton

378,00 0,00 378,00

35.1 4.

Four days (one inspector)

1 clinical research

centre/ related

institutiton

444,00 0,00 444,00

35.1 5.

Five days (one inspector)

1 clinical research

centre/ related

institutiton

510,00 0,00 510,00

35.2 Appraisal of conformity to the good clinical practice for a clinical research centre or a clinical

research-related institution in a country, which does not belong to the European Economic Area, inconnection with medicinal product certificate submission for re-registration of the medicinal

product*

35.2 1.

One day (one inspector)

1 clinical research

centre/ related

institutiton

450,00 0,00 450,00

35.2 2.

Two days (one inspector)

1 clinical research

centre/ related

institutiton

570,00 0,00 570,00

35.2 3.

Three days (one inspector)

1 clinical research

centre/ related

institutiton

690,00 0,00 690,00

35.2 4.

Four days (one inspector)

1 clinical research

centre/ related

institutiton

780,00 0,00 780,00

35.2 5.

Five days (one inspector)

1 clinical research

centre/ related

institutiton

910,00 0,00 910,00

36. Reviewing of amendments to the protocol of

clinical trial of a medicinal product*

1 amendment 150.00 0.00 150.00

37. Reviewing of an application and the enclosed

documents regarding surveillance of the use of

a medicinal product submitted on the initiative

of the manufacturer of the medicinal product

(its representative)*

1 expertise 200.00 0.00 200.00

38. Expertise of an application and the enclosed

documentation for import/export of

psychotropic and narcotic substances, as well

as precursors*

Expertise 15.00 0.00 15.00

39. Annual fee for receipt of information from the

database of the Latvian Register of Medicines

Subscription for 1

year

182.60 38.35 220.95

40. Medicinal product quality control*



40.1. Identification of a medicinal product

40.1.1. using a chemical reaction 1 test 10.40 0.00 10.40

40.1.2. using instrumental methods and thin-layer

chromatography (TLC)

1 test 26.65 0.00 26.65

40.2. transparency determination 1 test 4.42 0.00 4.42

40.3. colour conformity determination 1 test 4.42 0.00 4.42

40.4. solubility determination 1 test 4.42 0.00 4.42

40.5. pH determination 1 test 8.97 0.00 8.97

40.6. density determination 1 test 9.88 0.00 9.88

40.7. refraction coefficient identification 1 test 4.42 0.00 4.42

40.8. melting point identification 1 test 10.92 0.00 10.92

40.9. optical rotation determination 1 test 12.09 0.00 12.09

40.10. Identification of mechanical admixtures

40.10.1. visually 1 test 7.93 0.00 7.93

40.10.2. instrumentally 1 test 12.09 0.00 12.09

40.11. Identification of admixtures

40.11.1. using limiting test methods 1 test 8.71 0.00 8.71

40.11.2. using thin-layer chromatography (TLC) 1 test 34.45 0.00 34.45

40.12. Rated capacity identification 1 test 1.56 0.00 1.56

40.13. Identification of the mean mass and deviations

from the mean mass

1 test 5.46 0.00 5.46

40.14. Sulphate ash content identification 1 test 10.27 0.00 10.27

40.15. Heavy metal content identification 1 test 10.27 0.00 10.27

40.16. Determination of mass losses by drying 1 test 7.67 0.00 7.67

40.17. Water content identification 1 test 11.44 0.00 11.44

40.18. Disintegration determination 1 test 11.05 0.00 11.05



40.19. Crumbling determination 1 test 4.68 0.00 4.68

40.20. Solvency determination (without further

relevant quantitative analysis)

1 test 33.15 0.00 33.15

40.21. Determination of hardness of solid medicinal

forms

1 test 5.98 0.00 5.98

40.22. Identification of sizes of solid medicinal forms 1 test 5.98 0.00 5.98

40.23. osmolality determination 1 test 5.20 0.00 5.20

40.24. viscosity determination 1 test 16.50 0.00 16.50

40.25. Determination of homogeneity of active

substance content

40.25.1. using titration 1 test 72.28 0.00 72.28

40.25.2. using spectrophotometry 1 test 79.43 0.00 79.43

40.25.3. using polarimetry 1 test 50.70 0.00 50.70

40.25.4. using high-performance liquid

chromatography (HPLC)

1 test 116.48 0.00 116.48

40.25.5. using gas chromatography (GC) 1 test 81.25 0.00 81.25

40.25.6. using atomic absorption spectrometry (AAS) 1 test 116.35 0.00 116.35

40.26. Quantitative content determination:

40.26.1. using titration 1 test 29.12 0.00 29.12

40.26.2. using spectrophotometry 1 test 44.59 0.00 44.59

40.26.3. using polarimetry 1 test 21.06 0.00 21.06

40.26.4. using high-performance liquid

chromatography (HPLC)

1 test 81.38 0.00 81.38

40.26.5. using gas chromatography (GC) 1 test 47.32 0.00 47.32

40.26.6. using atomic absorption spectrometry (AAS) 1 test 75.14 0.00 75.14

40.27. Test for sterility 1 test 19.50 0.00 19.50

40.28. Microbiological purity determination 1 test 58.50 0.00 58.50



41. Medicine Quality Control Protocol translation

and presentation in English

1 protocol 19.50 3.51 23.01

42. Therapeutic herbal medicine quality control*

42.1. Identification

42.1.1. outer indicators (therapeutic herbal medicines) 1 test 2.20 0.00 2.20

42.1.2. microscopy (therapeutic herbal medicines) 1 test 9.36 0.00 9.36

42.2. Determination of admixtures in therapeutic

herbal medicines

1 test 8.19 0.00 8.19

42.3. Determination of quantitative content

42.3.1. extractive substances content in therapeuticherbal medicines

1 test 32.11 0.00 32.11

42.3.2. ether substances content in therapeutic herbal

medicines

1 test 32.11 0.00 32.11

42.4. Therapeutic herbal medicine comminution

level

1 test 4.29 0.00 4.29

43. Purified water quality control (in pharmacies) 1 sample 19.50 4.10 23.60

44. Preparation of titrated liquids, indicators and

reagents for pharmacies*

1 name 3.90 0.00 3.90

45. Water microbiological purity control 1 test 6.50 1.37 7.87

46. Transportation costs 1 km 0.20 0.04 0.24

47. Preparation of expert’s opinion at an official

request*

1 expert’s opinion 50.00 0.00 50.00

48. Provision of data on consumption of

medicines*

1 parameter 9.63 0.00 9.63

49. Product expertise for distribution of remaining stocks of medicinal products*

49.1. Medicines were not re-registered or their re-

registration was declined

for 1 medicine 10,00 0,00 10,00

49.2. Amendments to registration documentation for 1 medicine 10,00 0,00 10,00

50. Expertise of an application and the enclosed documentation for veterinary medicine registration by

the national procedure*



50.1. for firstly submitted medicinal form and

strength

Application 700,00 0,00 700,00

50.1.1. for each additional medicinal form Application 300,00 0,00 300,00

50.1.2. for each additional strength of the medicine Application 200,00 0,00 200,00

50.2. Homeopathic medicines Application 150,00 0,00 150,00

51. Expertise of an application and the enclosed documentation for veterinary medicine re-registration

by the national procedure*

51.1. for one medicinal form and strength Application 300.00 0.00 300.00

51.1.1. for each additional medicinal form Application 150.00 0.00 150.00

51.1.2. for each additional strength of the medicine Application 90.00 0.00 90.00

51.2. For re-registration of homeopathic medicines Application 90.00 0.00 90.00

52. Making amendments to the registration documentation of veterinary medicinal products*

52.1. Minor changes of Type I A Application 100.00 0.00 100.00

52.2. Minor changes of Type I B Application 150.00 0.00 150.00



Application 300.00 0.00 300.00



Application 100.00 0.00 100.00


change of a registration certificate holder

(where the new registration certificate holder

and the existing holder are not one and the

same person)

Application 100.00 0.00 100.00



Application 100.00 0.00 100.00

53. Expertise of an application and the enclosed documentation for veterinary medicine registration by

the interstate recognition procedure, where Latvia is an involved state*

53.1. for firstly submitted medicinal form Application 1200.00 0.00 1 200.00

53.1.1. for each additional medicinal form Application 600.00 0.00 600.00

53.3 Each additional strength or commercial

packaging of a medicine, each application


Application 400.00 0.00 400.00







53.1 Expertise of an application and the enclosed documentation for veterinary medicine registration by

the decentralized procedure, where Latvia is an involved state *

53.11. for firstly submitted medicinal form Application 1200.00 0.00 1 200.00

53.12. for each additional medicinal form Application 600.00 0.00 600.00

53.13. Each additional strength or commercial







Application 400.00 0.00 400.00

53.2 Expertise of an application and the enclosed documentation for re-registration of veterinary

products, which were registered by the interstate recognition procedure or decentralized procedure,

where Latvia is

53.2 1. a reference state*

53.2 1.1.

for firstly submitted medicinal form Application

800,00 0,00 800,00

53.2 1.2.

for each additional medicinal form Application

500,00 0,00 500,00

53.2

1.3. Each additional strength or commercial packaging of a medicine, each application






Application200,00 0,00 200,00

53.2 1.4. For a procedure (in addition to Subparagraphs

53.2 1.1, 53.2 1.2 and 53.2 1.3)

Procedure number 1500,00 0,00 1500,00

53.2 2. an involved member-state*

53.2 2.1.

for firstly submitted medicinal form Application

800,00 0,00 800,00

53.2 2.2.

for each additional medicinal form Application

500,00 0,00 500,00

53.2 2.3. Each additional strength or commercial







Application

200,00 0,00 200,00

54. Veterinary medicine post-registration surveillance (per annum)*

54.1. each registered medicine’s form and strength

(concentration)




54.2. each registered homeopathic veterinary

medicine


55. Appraisal of documents relating to good

veterinary manufacturing practice*

Expertise 100.00 0.00 100.00

56. Appraisal of conformity of veterinary pharmaceutical businesses*

56.1. Appraisal of conformity of a wholesaler of


1 wholesaler of


300.00 0.00 300.00

56.2. Appraisal of conformity of a branch of a

wholesaler of veterinary medicines

1 branch of a

wholesaler of


70.00 0.00 70.00

56.3. Appraisal of conformity of an enterprise of a

wholesaler of veterinary medicines

1 enterprise of a

wholesaler of


400.00 0.00 400.00

56.4. Appraisal of conformity of veterinary

medicines production (partial production

process) enterprise

1 medicines or


production enterprise

300.00 0.00 300.00

57. Fee for verification of the assurance of good manufacturing practice at an enterprise producing or

importing medicines or veterinary medicines, or a laboratory that carries out quality control on a

contractual basis* and if the inspection at the site lasts for:

57.1. One day (one inspector) 1 medicines or veterinary medicines


246.00 0.00 246.00

57.2. Two days (one inspector) 1 medicines or



312.00 0.00 312.00

57.3. Three days (one inspector) 1 medicines or



378.00 0.00 378.00

57.4. Four days (one inspector) 1 medicines or



444.00 0.00 444.00

57.5. Five days (one inspector) 1 medicines or



510.00 0.00 510.00

57.1 Fee for verification of the assurance of good manufacturing practice in a country, which does not

belong to the European Economic Area, at an enterprise producing medicines or veterinary

medicines, or a laboratory that carries out quality control on a contractual basis* and if the inspection

at the site lasts for:



57.1 1.

One day (one inspector) 1 medicines or



369,00 0,00 369,00

57.1 2.

Two days (one inspector) 1 medicines or



468,00 0,00 468,00

57.1 3.Three days (one inspector) 1 medicines or



567,00 0,00 567,00

57.1 4.

Four days (one inspector) 1 medicines or



666,00 0,00 666,00

57.1 5.

Five days (one inspector) 1 medicines or



765,00 0,00 765,00

58. Expertise of the application and enclosed documentation for registration of a veterinary medicine by

the procedure of interstate recognition of veterinary medicines, where Latvia is a reference state*

58.1. for firstly submitted veterinary medicine form Application 2 000.00 0.00 2 000.00

58.1.1. for each additional veterinary medicine form Application 1 200.00 0.00 1 200.00

58.1.2. Each additional strength or commercial packaging of a veterinary medicine, each


registration documentation but different

names of medicines and the same or different



Application 600.00 0.00 600.00

58.2. Expertise of an application and the enclosed documentation for veterinary medicine registration by

the decentralized procedure, where Latvia is a reference state*

58.2.1. for firstly submitted veterinary medicine form Application 2 000.00 0.00 2 000.00

58.2.2. for each additional veterinary medicine form Application 1 200.00 0.00 1 200.00

58.2.3. Each additional strength or commercial

packaging of a veterinary medicine, each


registration documentation but different

names of medicines and the same or different



Application 600.00 0.00 600.00

59. Fee for verification of the assurance of good manufacturing practice at an enterprise producing or

importing raw materials, which is performed at the request of the medicine or veterinary medicine

manufacturer,* and if the inspection at the site lasts for:



59.1. One day (one inspector) 1 medicines production

enterprise

305.00 0.00 305.00

59.2. Two days (one inspector) 1 medicines production

enterprise

381.00 0.00 381.00

59.3. Three days (one inspector) 1 medicines production

enterprise

460.00 0.00 460.00

59.4. Four days (one inspector) 1 medicines production

enterprise

522.00 0.00 522.00

59.5. Five days (one inspector) 1 medicines production

enterprise

610.00 0.00 610.00

59.1 Fee for verification of the assurance of good manufacturing practice, which is performed at the

request of the medicine or veterinary medicine manufacturer,* in a country, which does not belong

to the European Economic Area, and if the inspection at the site lasts for:

59.1 1.

One day (one inspector) 1 medicines or



450,00 0,00 450,00

59.1 2.

Two days (one inspector) 1 medicines or



570,00 0,00 570,00

59.1 3.

Three days (one inspector) 1 medicines or

veterinary medicines production enterprise

690,00 0,00 690,00

59.1 4.

Four days (one inspector) 1 medicines or



780,00 0,00 780,00

59.1 5.

Five days (one inspector) 1 medicines or



910,00 0,00 910,00

60. Appraisal of the background and professionalexperience of the qualified persons of a

medicines manufacturer or importer in terms

of conformity to the normative acts

requirements to medicines manufacture*

1 medicines producing person

70.00 0.00 70.00

61. Appraisal of the documents related to the

good manufacturing practice of a medicines

production enterprise, which is not located in

an EU member-state – appraisal of the

submitted description of the production

facilities and procedures*

1 medicines production

enterprise

150.00 0.00 150.00

62. Selection of samples of medicines for

testing*

1 sample of medicine 3.00 0.00 3.00



63. Expertise of an application and

documentation for distribution of parallel

imports of veterinary medicines in Latvia,

and making relevant amendments*

Expertise 211.87 0.00 211.87

63.1. Changes in user instructions of a veterinary

medicine

Expertise 50.00 0.00 50.00

63.2. changes in marking of a veterinary medicine Expertise 50.00 0.00 50.00

63.3. amendments in a document (change of the

entrepreneur’s registered office address)

Expertise 50.00 0.00 50.00

64. Expertise of the application and documentation for distribution of non-registered veterinary

medicines (in such cases as provided for The Pharmacy Act, Clause 10, Paragraph 7, Subparagraph

"a")*

64.1. first entry of a veterinary medicine Expertise 0.50 0.00 0.50

64.2. each subsequent entry of a veterinary

medicine

Expertise 0.50 0.00 0.50

65. Expertise of the application and documentation for distribution of non-registered, individually

assigned veterinary medicines (in such cases as provided for The Pharmacy Act, Clause 10,

Paragraph 7, Subparagraph "b" and "d")*

65.1. first entry of a veterinary medicine Expertise 15.00 0.00 15.00

65.2. each subsequent entry of a veterinary

medicine

Expertise 4.75 0.00 4.75

77. Expertise of an application and documentation

for distribution of the remaining stocks of

veterinary medicines if the said medicines

were not re-registered or their re-registration

was declined*

Expertise 10.00 0.00 10.00


for distribution of non-registered medicines*

Expertise 500.00 0.00 500.00


for distribution of non-registered veterinary

medicines *

Expertise 300.00 0.00 300.00

80. Special expertise of an application and

documentation for work with precursors*

Expertise 50.00 0.00 50.00

81. Issue of precursors operator cards* Expertise 50.00 0.00 50.00


for the use of plants, substances and

medicines, which are on the list of narcotic,

psychotropic substances and precursors I, II

Expertise 50.00 0.00 50.00



un III, that are under control in Latvia, for the

purposes of medical and veterinary medical

research studies, and determination of

physical and chemical properties, as well as

for training purposes*

83. Conformity appraisal, verification of good manufacturing practice assurance at the facilities of a

wholesaler of medicinal products*, if the inspection at the site lasts for:

83.1. Half a day (one inspector) 1 wholesaler of

medicinal products

61.71 0.00 61.71

83.2. One day (one inspector) 1 wholesaler of

medicinal products

123.41 0.00 123.41

83.3. Two days (one inspector) 1 wholesaler of

medicinal products

156.32 0.00 156.32

84. Appraisal of conformity of a veterinary medicines wholesaler’s facilities, equipment, installations

and personnel to the requirements of the normative acts regarding distribution of veterinary

medicines*, if the inspection at the site lasts for:

84.1. Half a day (one inspector) 1 wholesaler of


61.71 0.00 61.71

84.2. One day (one inspector) 1 wholesaler of


123.41 0.00 123.41

84.3. Two days (one inspector) 1 wholesaler of


156.32 0.00 156.32

85. Copying of documents 1 page 0.13 0.03 0.16

86. Official publication of Latvian Register of

Medicines

1 book 3.70 0.78 4.48

87. Statistical publication on consumption of

medicines

1 compact disc 4.00 0.84 4.84

88. Official publication of Latvian Register of

Veterinary Medicines

1 book 2.50 0.53 3.03

89. Issue of Medicine Registration Certificate* Registration Certificate 50.00 0.00 50.00

90. Issue of Veterinary Medicine Registration

Certificate*

Registration Certificate 50.00 0.00 50.00

91. Issue of a duplicate of Medicine RegistrationCertificate* Duplicate of Registration Certificate 30.00 0.00 30.00

92. Issue of a duplicate of Veterinary Medicine

Registration Certificate *

Duplicate of

Registration Certificate

30.00 0.00 30.00



93. Issue of good manufacturing practice

certificate for medicines *

Certificate 65.00 0.00 65.00

94. Issue of good manufacturing practice

certificate for veterinary medicines*

Certificate 65.00 0.00 65.00

95. Issue of permit to distribute medicines or

veterinary medicines that are imported in parallel*

Permit 5.00 0.00 5.00

96. Issue of permit to import samples of

medicines or veterinary medicines*

Permit 5.00 0.00 5.00

97. Issue of permit to import or export

psychotropic and narcotic substances and

medicines, as well as precursors*

Permit 15.00 0.00 15.00

98. Issue of permit to distribute remaining stocksof medicines or veterinary medicines if the

said medicines were not re-registered or their

re-registration was declined*

Permit 50.00 0.00 50.00

99. Issue of product certificate* Certificate 65.00 0.00 65.00

99.1 Issue of an abbreviated product certificate

(pharmaceutical product certificate or free

trade certificate)*

Certificate 40,00 0,00 40,00

100. Issue of licence to work with precursors* Licence 50.00 0.00 50.00

101. Decision on approval of advertising of

medicinal products*

Decision 20.00 0.00 20.00

102. Decision on approval of advertising of

veterinary medicinal products *

Decision 20.00 0.00 20.00

103. Permit to carry out a clinical trial of medicinal

products*

Permit 20.00 0.00 20.00

104. Expertise of medical devices/tools and related documentaton104.1. Expertise of medical devices/tools made in Latvia and the related documentaton

104.1.1. Expertise of medical devices/tools of Class I

and and the related documentaton (except for

the provisions of Subparagraph 104.1.2)

1 expertise 90,00 0,00 90,00


in sterial packaging and Class I medical

devices with a measuring function and the

related documentaton

1 expertise 95,00 0,00 95,00

104.1.3. Expertise of medical devices/tools of Class II

A and and the related documentaton

1 expertise 100,00 0,00 100,00

104.1.4. Expertise of medical devices/tools of Class IIB and and the related documentaton

1 expertise 110,00 0,00 110,00

104.1.5. Expertise of medical devices/tools of Class III

and and the related documentaton

1 expertise 120,00 0,00 120,00

104.1.6. Expertise of medical devices/tools meant for 1 expertise 120,00 0,00 120,00



IVD (in vitro diagnostics) as provided for in

the Cabinet Regulations No.581 of 2 August

2005 ‘Medical Devices/Tools Registration,

Conformity Appraisal, Distribution, Operation

and Technical Control Procedure’, Annex 2,

List A, and the related documentation

104.1.7. Expertise of medical devices/tools meant for



2005 ‘Medical Devices/Tools Registration,Conformity Appraisal, Distribution, Operation


List B, and the related documentation

1 expertise 110,00 0,00 110,00

104.1.8. Expertise of self-verifying medical devices

meant for IVD (in vitro diagnostics) and the

related documentation

1 expertise 100,00 0,00 100,00

104.1.9. Expertise of other medical devices meant for

IVD (in vitro diagnostics) and the related

documentation

1 expertise 90,00 0,00 90,00

104.1.10. Supplementation of expertise data if a new

medical device specimen is produced or thetype specimen is changed or the production

technology is changed for the already

registered medical devices/tools

1 expertise 45,00 0,00 45,00

104.2. Expertise of other medical devices without CE marking and their quality-certifying documentaton*


and and their quality-certifying documentaton

(except for the provisions of Subparagraph

104.2.2)

1 expertise 250,00 0,00 250,00


in sterial packaging and Class I medical

devices with a measuring function and their quality-certifying documentaton

1 expertise 280,00 0,00 280,00


A and and their quality-certifying

documentaton

1 expertise 300,00 0,00 300,00


B and and the quality-certifying documentaton

1 expertise 320,00 0,00 320,00

104.2.5. Expertise of medical devices/tools of Class III

and and their quality-certifying documentaton

1 expertise 350,00 0,00 350,00



the Cabinet Regulations No.581 of 2 August2005 ‘Medical Devices/Tools Registration,



List A, and quality-certifying documentation

1 expertise 350,00 0,00 350,00




2005 ‘Medical Devices/Tools Registration,



List B, and quality-certifying documentation

1 expertise 320,00 0,00 320,00

104.2.8. Expertise of self-verifying medical devices

meant for IVD (in vitro diagnostics) and their

quality-certifying documentation

1 expertise 300,00 0,00 300,00

104.2.9. Expertise of other medical devices meant for

IVD (in vitro diagnostics) and their quality-

1 expertise 250,00 0,00 250,00



certifying documentation

105. Expertise of documentation of specially delivered medical devices/tools and/or accessories*

105.1. Medical devises/tools made in Latvia without CE marking, which have not undergone the conformity

appraisal procedures as provided for in the Cabinet Regulations No.581 of 2 August 2005 ‘Medical

Devices/Tools Registration, Conformity Appraisal, Distribution, Operation and Technical Control

Procedure’

105.1.1. One-time expertise of medical devices/tools of

Class I and and the related documentaton

(except for the provisions of Subparagraph105.1.2)

1 expertise 50,00 0,00 50,00


Class I in sterial packaging and Class I

medical devices with a measuring function

and the related documentaton

1 expertise 50,00 0,00 50,00


Class II A and and the related documentaton

1 expertise 55,00 0,00 55,00


Class II B and and the related documentaton

1 expertise 60,00 0,00 60,00


Class III and and the related documentaton

1 expertise 70,00 0,00 70,00

105.1.6. One-time expertise of medical devices/tools

meant for IVD (in vitro diagnostics) as

provided for in the Cabinet Regulations

No.581 of 2 August 2005 ‘Medical

Devices/Tools Registration, Conformity

Appraisal, Distribution, Operation and

Technical Control Procedure’, Annex 2, List

A, and the related documentation

1 expertise 70,00 0,00 70,00




No.581 of 2 August 2005 ‘MedicalDevices/Tools Registration, Conformity



B, and the related documentation

1 expertise 60,00 0,00 60,00

105.1.8. One-time expertise of self-verifying medical

devices meant for IVD (in vitro diagnostics)

and the related documentation

1 expertise 55,00 0,00 55,00

105.1.9. One-time expertise of other medical devices

meant for IVD (in vitro diagnostics) and the

related documentation

1 expertise 50,00 0,00 50,00

105.2. Medical devises/tools without CE marking, which have not undergone the conformity appraisal procedures as provided for in the Cabinet Regulations No.581 of 2 August 2005 ‘Medical

Devices/Tools Registration, Conformity Appraisal, Distribution, Operation and Technical Control

Procedure’ (except such devices as made in Latvia)


Class I and and their quality-certifying

documentaton (except for the provisions of

Subparagraph 105.2.2)

1 expertise 120,00 0,00 120,00


Class I in sterial packaging and Class I

medical devices with a measuring function

and their quality-certifying documentaton

1 expertise 140,00 0,00 140,00


Class II A and and their quality-certifying

documentaton

1 expertise 150,00 0,00 150,00


Class II B and and the quality-certifying

1 expertise 170,00 0,00 170,00



documentaton


Class III and and their quality-certifying

documentaton

1 expertise 180,00 0,00 180,00








A, and their quality-certifying documentation

1 expertise 180,00 0,00 180,00








B, and their quality-certifying documentation

1 expertise 170,00 0,00 170,00

105.2.8. One-time expertise of self-verifying medicaldevices meant for IVD (in vitro diagnostics)

and their quality-certifying documentation

1 expertise 150,00 0,00 150,00

105.2.9. One-time expertise of other medical devices

meant for IVD (in vitro diagnostics) and their

quality-certifying documentation

1 expertise 120,00 0,00 120,00

106. Preparation of documentation*

106.1. Issue of confirmation of a medical device

registration certificate

Confirmation

of

registration

certificate

20,00 0,00 20,00

106.2. Issue of confirmation of a medical deviceregistration certificate

Duplicate of registration

certificate

10,00 0,00 10,00

106.3. Issue of a medical device registration

certificate

registration

certificate

50,00 0,00 50,00

106.4. Issue of a permit for release of specially

delivered medical devices

permit 20,00 0,00 20,00

106.5. Issue of a dublicate of permit for release of

specially delivered medical devices

Duplicate of

permit

10,00 0,00 10,00

107. Annual fee for the use of the Register of

Medical Devices of the 1st and 2nd security

groups of the Latvian Database of MedicalDevices*

1 annual

subscription

50,00 0,00 50,00

108. Conformity appraisal of procurement of blood, tissues, cells and organs*

108.1. Conformity appraisal of a blood room, blood

preparation department and centre

1 institution 450,00 0,00 450,00

108.1.1. Appraisal of documentation on changes in the

operations of a blood room, blood preparation

department and centre

1 expertise 50,00 0,00 50,00

108.2. Conformity appraisal of a Tissues, Cells and

Organs Procurement and Storage Centre

1 institution 450,00 0,00 450,00

108.2.1. Appraisal of documentation on changes in the

opeartions and standard procedures of aTissues, Cells and Organs Procurement and

Storage Centre

1 expertise 50,00 0,00 50,00



Note: * The Value-Added Tax is inapplicable as provided by The Value-Added Tax Act , Clause 2, Part

Twenty Two, and Clause 6, Part One, Paragraph 9.1.

zva cenradis 1008 en

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