Rules Of The State Agency Of Medicines Of The Public Paid Services Price List

Original Language Title: Noteikumi par Zāļu valsts aģentūras publisko maksas pakalpojumu cenrādi

Read the untranslated law here: https://www.vestnesis.lv/ta/id/127125

Cabinet of Ministers Regulations No. 61 in Riga in 2006 (17 January. 3. § 34) rules of the State Agency of medicines of the public paid services price list Issued in accordance with the law on budget and financial management of the ninth article 5 part 1. determines the State Agency of medicines to the public provided by the paid service price list.
2. the State Agency of medicines shall provide public services in accordance with the fee schedule (annex).
Prime Minister a. Halloween Health Minister g. Smith Editorial Note: rules shall enter into force on the 3 February 2006.
 
Annex to the Cabinet of Ministers of 17 January 2006, the Regulation No 61 of the State Agency of Medicines a public charge service price list 1 2 3 4 5 6 no PO box
Public service unit of Measure you Izcen (Ls) VAT (Ls) price 1 2 3 4 5 6 1.
Examination registration: 1.1.
the first proposed medicine form and strengths: expertise 1200.00 216.00 1416.00 1.1.1.
each additional dosage forms for inspection 600.00 106.00 708.00 1.1.2.
for each additional strength for inspection 400.00 72.00 472.00 1.2.
homeopathic medicinal products with a reasonable medical indications and medications used in diagnosis: inspection 170.00 30.60 200.60 1.2.1.
each additional dosage forms for inspection 80.00 14.40 94.40 1.3.
homeopathic medicine without medical indications (simplified registration procedure) inspection 100.00 18.00 118.00 1.4.
traditional herbal medicinal products: expertise 400.00 72.00 472.00 1.4.1.
each additional dosage forms for inspection 200.00 36.00 236.00 1.4.2.
for each additional strength to 80.00 14.40 94.40 expertise 2.
Expertise in medicine for renewal: 2.1.
one pharmaceutical form and strength: expertise 470.00 84.60 554.60 2.1.1.
each additional dosage forms for inspection 240.00 43.20 283.20 2.1.2.
for each additional strength expertise to 90.00 16.20 106.20 2.2.
homeopathic medicinal products with a reasonable medical indications and used diagnostic inspection 90.00 16.20 106.20 2.3.
homeopathic medicinal products with medical indications (simplified registration procedure) inspection 50.00 9.00 59.00 2.4.
traditional herbal medicinal products: expertise 240.00 43.20 283.20 2.4.1.
each additional dosage forms for inspection 120.00 21.60 14.60 2.4.2.
for each additional strength to 120.00 21.60 141.60 expertise 3.
Changes in the documentation for the registration and issue of a duplicate certificate of registration: 3.1.
Type IA expertise 100.00 18.00 118.00 3.2.
I type B inspection 150.00 27.00 177.00 3.3.
Type II changes that evaluation requires an in-depth scientific evaluation expertise 300.00 54.00 354.00 3.4.
Type II changes that do not require in-depth assessment of scientific evaluation expertise 100.00 18.00 118.00 3.5.
the holder of the registration certificate (ownership) changes due to exchange expertise 100.00 18.00 118.00 3.6.
changes in the instructions for use or on the label that are not related to changes in the summary of inspection 100.00 18.00 118.00 3.7.
the issue of a duplicate certificate of registration in the registration certificate 50.00 9.00 59.00 4.
Examination registration mutual registration recognition procedure and the decentralised procedure, in which Latvia is responsible (reference): 4.1.
the first proposed medicine form and strengths: expertise 2000.00 360.00 2360.00 4.1.1.
each additional dosage forms for inspection 1200.00 216.00 1416.00 4.1.2.
for each additional strength for inspection 600.00 108.00 708.00 4.1.3.
drug evaluation report evaluation report 800.00 144.00 944.00 4.2.
the drug, which is used in diagnosis: inspection 1000.00 180.00 1180.00 4.2.1.
each additional dosage forms for inspection 800.00 144.00 944.00 4.2.2.
for each additional strength to 500.00 90.00 590.00 expertise 4.3.
traditional herbal medicinal products: expertise 1200.00 216.00 1416.00 4.3.1.
each additional dosage forms for inspection 800.00 144.00 944.00 4.3.2.
for each additional strength to 400.00 72.00 472.00 expertise 5.
Expertise in registration for the mutual recognition of the registration procedure and the decentralised procedure, in which Latvia is participating: 1000.00 180.00 1180.00 5.1 expertise.
each additional dosage forms for inspection 600.00 108.00 708.00 5.2.
for each additional strength to 400.00 72.00 472.00 expertise 6.
Post-marketing surveillance of medicines (year): 6.1.
each registered pharmaceutical form and strength, except this list referred to in point 6.2 Hall registration number 350.00 63.00 413.00 6.2.
traditionally used in herbal medicine and drugs which are used in diagnosis 100.00 18.00 118.00 number 6.3.
each registered homeopathic medicine with reasonable medical indications registration number 100.00 18.00 118.00 6.4.
registered homeopathic medicine without medical indications (simplified registration) registration number 30.00 5.40 35.40 7.
Review the product documentation to determine its compliance with the definition: 7.1.
products (food supplements, cosmetics, biocides, medical devices) on the label and in the instructions for use included in the evaluation of the information expertise 60.00 10.80 70.80 7.2.
effects of physiological function of the product and the medical evaluation of the inspection indicating 240.00 43.20 283.20 8.
Medicine import, export and distribution authorisation and renewal: 8.1.
the authorization for imports of the product in Latvia from third countries and distribution: 8.1.1.
the first entry in the authorisation of medicinal products authorised 30.00 5.40 35.40 8.1.2.
each subsequent entry in the authorisation of medicinal products authorised 10.00 1.80 11.80 8.2.
renewal of authorization: 8.2.1.
If you changed the name of the medicinal product, shape, strength, registration number Latvia register of medicinal products, the manufacturer of the medicinal product change 15.00 2.70 17.70 8.2.2.
If you changed the data for the permit holder or drug dealer change 8.00 1.44 9.44 9.
The issue of the parallel distribution of medicinal products imported into Latvia and changes in the authorization: permission 211.87 38.14 250.01 9.1.
changes to the package leaflet of the medicinal product inspection 50.00 9.00 59.00 9.2.
changes in the labelling of the medicinal product inspection 50.00 9.00 59.00 9.3.
changes to permit inspection 50.00 9.00 59.00 10.
Authorisation of clinical investigational medicinal product (preparation study) introduction in Latvia or removal from Latvia: 10.1.
the first entry in the authorisation of medicinal products authorised 17.00 3.06 20.06 10.2.
each subsequent entry in the authorisation of medicinal products authorised 7.75 1.40 9.15 11.
The issue of the importation of medicinal products not registered in Latvia and unreported distribution of medicinal products (article 10 of the law on Pharmacy 7 "a" in the case referred to in subparagraph) permit 0.17 0.03 0.20 12.
The issue of the importation of medicinal products not registered in Latvia (pharmaceutical law article 7, point "b" and "c" in the cases referred to in subparagraph): 12.1.
the first entry in the authorisation of medicinal products authorised 5.00 0.90 5.90 12.2.
each subsequent entry in the authorisation of medicinal products authorised 1.00 0.18 1.18 13.
The issue of the distribution of medicinal products not registered in Latvia (pharmaceutical law article 7, point "b" and "c" in the cases referred to in subparagraph): 13.1.
the first entry in the authorisation of medicinal products authorised 15.00 2.70 17.70 13.2.
each subsequent entry in the authorisation of medicinal products authorised 4.75 0.86 5.61 14.
The issue of the registration, renewal or change registration documentation for approval of medicines in the sample for single admission or removal from Latvia in Latvia: 14.1.
up to five entries in the authorisation of medicinal products authorised 5.00 0.90 5.90 14.2.
each subsequent entry in the authorisation of medicinal products authorised 1.00 0.18 1.18 15.
Special permission (license) the pharmaceutical activity in re-registering when changes to the data of the person licensed to: 15.1.
the legal status of the person licensed or merchant change forms for international transactions 1 company 30.00 5.40 35.40 15.2.
merchant name (branded) and pharmaceutical activities of company name (if different from company name) forms for the international exchange of 1 operations the company license 30.00 5.40 35.40 15.3.
the operator's legal address change forms for international transactions 1 company license 30.00 5.40 35.40 15.4.
the individual's last name, legal address change forms for international transactions 1 company license 30.00 5.40 35.40 15.5.
Pharmacy, medicine for lieltirgotav officers or pharmaceutical company officers last name change forms for international transactions 1 company license 30.00 5.40 35.40 15.6.
the Pharmacy Department of the branch or of the closure of the lieltirgotav forms of international activities 1 corporate license 30.00 5.40 35.40 15.7.
changes to special permission (license) the pharmaceutical activities in the annex are not pharmaceutical activities evaluation of conformity of the company forms the international activities of 1 company license 30.00 5.40 35.40 15.8.

changes in special pharmaceutical operations terms, if failure to comply with any of the licenses mentioned in the annexes to the special operating conditions 1 for the international activities of the enterprise forms license 30.00 5.40 35.40 16.
Consideration of the application of the special permission (license) the pharmaceutical activity in suspension for illegal activities forms 1 company license 10.00 1.80 11.80 17.
Consideration of the application of the special permission (license) the pharmaceutical activity in restore, if you do not want the pharmaceutical activities evaluation of conformity of the company forms the international activities of 1 company license 10.00 1.80 11.80 18.
Of good manufacturing practice certificate of issue of the certificate 100.00 18.00 118.00 19.
Pharmaceutical company conformity assessment activities: 19.1.
the General type of Pharmacy: 19.1.1.
If the pharmacy is located in the city of 1 drugstore 80.00 14.40 94.40 19.1.2.
If the pharmacy is located in the city and it is one branch of Pharmacy and 1 branch 70.00 12.60 82.60 19.1.3.
If the pharmacy is located in the city and has two branches and 2 branches of Pharmacy 60.00 10.80 70.80 19.1.4.
If the pharmacy is located in the countryside 1 pharmacy 30.00 5.40 35.40 19.1.5.
If the pharmacy is located in the countryside and it has one branch 1 pharmacy 35.00 6.30 41.30 19.1.6.
If the pharmacy is located in the countryside and has two branches 1 pharmacy 40.00 7.20 47.20 19.2.
closed type of Pharmacy 1 pharmacy 30.00 5.40 35.40 19.3.
drugstore one branch, if it is not necessary to carry out the assessment of conformity with the pharmacy 1 branch 20.00 3.60 23.60 19.4.
drug lieltirgotav (good distribution practice) 1 200.00 36.00 236.00 19.5 of medicine lieltirgotav
lieltirgotav Division of medicinal products (good distribution practice) 1 Medicine Department lieltirgotav 50.00 9.00 59.00 12.2.
pharmaceutical company (good manufacturing practice) 1 pharmaceutical company 300.00 54.00 354.00 20.
Evaluation of conformity of the manufacture of medicinal products in pharmacies: 20.1.
If the pharmacy is located in the city of 1 drugstore 40.00 7.20 47.20 20.2.
closed type pharmacy or pharmacies, located in fields 1 pharmacy 20.00 3.60 23.60 21.
Conformity assessment for the manufacture of medicinal products (medicinal products, repackaging and packaging) 1 lieltirgotav lieltirgotav of medicinal 100.00 18.00 118.00 22.
Videoreklām evaluation of the medicinal product: 1 promotional material 80.00 14.40 94.40 22.1.
accelerated assessment within 10 working days after the receipt of the material required 1 160.00 28.80 188.80 22.2 promotional material.
accelerated examination within five working days after the receipt of the material required 1 promotional material 320.00 57.60 377.60 22.3.
additional information evaluation, if it is not included in the summary of product characteristics and the source of the information submitted is accurate indication of advertising that fact: 1 promotional material 20.00 3.60 23.60 22.3.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 40.00 7.20 47.20 22.3.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 80.00 14.40 94.40 22.4.
additional information evaluation, if it is not included in the summary of product characteristics and information submitted in the source is not a precise indication of the facts referred to in advertising: 1 promotional material 30.00 5.40 35.40 22.4.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 60.00 10.80 70.80 22.4.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 120.00 21.60 141.60 22.5.
deployment on conveyor belts in medicine beforehand video advertising for information evaluation: 1 promotional material 10.00 1.80 11.80 22.5.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 20.00 3.60 23.60 22.5.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 40.00 7.20 47.20 23.
Medicine reminder videoreklām evaluation: 1 promotional material 10.00 1.80 11.80 23.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 20.00 3.60 23.60 23.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 40.00 7.20 47.20 24.
Evaluation of Audioreklām: 1 promotional material 50.00 9.00 59.00 24.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 100.00 18.00 118.00 15.0.
accelerated examination within five working days after the receipt of the material required 1 200.00 36.00 236.00 24.3 promotional material.
additional information evaluation, if it is not included in the summary of product characteristics and the source of the information submitted is accurate indication of advertising that fact: 1 promotional material 20.00 3.60 23.60 24.3.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 40.00 7.20 47.20 24.3.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 80.00 14.40 94.40 24.4.
additional information evaluation, if it is not included in the summary of product characteristics and information submitted in the source is not a precise indication of the facts referred to in advertising: 1 promotional material 30.00 5.40 35.40 24.4.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 60.00 10.80 70.80 24.4.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 120.00 21.60 141.60 25.
Medicine reminder audioreklām evaluation: 1 promotional material 10.00 1.80 11.80 25.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 20.00 3.60 23.60 25.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 40.00 7.20 47.20 26.
Written advertising evaluation (one medicinal product): 1 promotional material 30.00 5.40 35.40 26.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 60.00 10.80 70.80 26.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 120.00 21.60 141.60 26.3.
additional information evaluation, if it is not included in the summary of product characteristics and the source is a precise indication of the facts referred to in advertising: 1 promotional material 20.00 3.60 23.60 26.3.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 40.00 7.20 47.20 26.3.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 80.00 14.40 94.40 26.4.
additional information evaluation, if it is not included in the summary of product characteristics and information submitted in the source is not a precise indication of the facts referred to in advertising (volume 30 p.): 1 promotional material 30.00 5.40 35.40 26.4.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 60.00 10.80 70.80 26.4.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 120.00 21.60 141.60 26.5.
additional information evaluation, if it is not included in the summary of product characteristics and information submitted in the source is not a precise indication of the facts referred to in the ad (from 31 to 50 p.): 1 promotional material 50.00 9.00 59.00 26.5.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 100.00 18.00 118.00 26.5.2.
accelerated examination within five working days after the receipt of the material required 1 200.00 36.00 236.00 16.5 promotional material.
additional information evaluation, if it is not included in the summary of product characteristics and information submitted in the source is not a precise indication of the facts referred to in the advertisement (amount more than 51 p.): 1 promotional material 80.00 14.40 94.40 26.6.1.
accelerated assessment within 10 working days after the receipt of the material required 1 160.00 28.80 188.80 26.6.2 in the promotional material.
accelerated examination within five working days after the receipt of the material required 1 promotional material 320.00 57.60 377.60 27.
Previously approved written promotional evaluation of changes (up to 200 characters): 1 promotional material 10.00 1.80 11.80 27.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 20.00 3.60 23.60 27.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 40.00 7.20 47.20 28.
Written reminder advertising evaluation (drugs): 1 promotional material 5.00 0.90 5.90 28.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 10.00 1.80 11.80 28.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 20.00 3.60 23.60 29.
Advertising material submitted, on the basis of the information contained in the conformity evaluation of the advertising of a medicinal product status: 1 promotional material 30.00 5.40 35.40 29.1.

accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 60.00 10.80 70.80 29.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 120.00 21.60 141.60 30.
The above concerted drug videoreklām evaluation permit extension: 1 promotional material 30.00 5.40 35.40 30.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 60.00 10.80 70.80 30.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 120.00 21.60 141.60 31.
The above concerted drug audioreklām evaluation permit extension: 1 promotional material 20.00 3.60 23.60 31.1.
accelerated promotional material evaluation within 10 working days after the receipt of the material required 1 promotional material 40.00 7.20 47.20 31.2.
accelerated promotional material evaluation within five working days after the receipt of the material required 1 promotional material 80.00 14.40 94.40 32.
The above concerted drug ads written permission of extension evaluation: 1 promotional material 10.00 1.80 11.80 32.1.
accelerated assessment within 10 working days after the receipt of the material required 1 promotional material 20.00 3.60 23.60 32.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 40.00 7.20 47.20 33.
Application of clinical trials of medicinal products and the inspection of documentation review 1 800.00 144.00 944.00 34.
Drug clinical trial protocol review 1 Amendment 120.00 21.60 141.60 35.
Drug manufacturer (representative of) the proposed use of the observation application and attached documents 1 inspection 150.00 27.00 177.00 review 36.
Authorisation of psychotropic and narcotic substances and precursors, as well as medicinal products on importation or exportation permit 15.00 2.70 17.70 37 1.
The issue of the certificate of the product certificate 65.00 11.70 76.70 38 1.
Information service of the Latvian drug registry database 1 year subscription 152.16 27.39 179.55 39.
Quality control of medicinal products: 24.3.
identity of the medicinal product: 39.1.1.
through a chemical reaction 1 analysis 8.00 1.44 9.44 39.1.2.
using instrumental methods and thin-layer chromatography (PSH) 1 Analysis 20.50 3.69 24.19 24.4.
determination of clarity 1 analysis 3.40 0.61 4.01 39.3.
color analysis of conformity determination 1 3.40 0.61 4.01 24.5.
determination of solubility analysis 1 3.40 0.61 4.01 24.5.
Ph determination 1 analysis 6.90 1.24 8.14 24.6.
density determination analysis 7.60 1.37 8.97 24.7 1.
determination of the refractive index 1 analysis 3.40 0.61 4.01 24.7.
determination of the melting temperature 1 analysis 8.40 1.51 9.91 24.8.
determination of the optical rotation analysis 1 9.30 1.67 10.97 39.10.
mechanical impurities: 39.10.1.
Visual analysis of 6.10 1.10 7.20 1 39.10.2.
instrumental analysis 1 9.30 1.67 10.97 39.11.
determination of impurities: 39.11.1.
using the maintenance methods of test 1 39.11.2 6.70 1.21 7.91 analysis.
using thin-layer chromatography (PSH) 1 analysis 26.50 4.77 31.27 39.12.
determination of nominal volume 1 analysis 1.20 0.22 1.42 39.13.
mean weight and the deviations from the mean weight determination 1 analysis 4.20 0.76 4.96 39.14.
sulphate ash 1 quantification analysis 7.90 1.42 9.32 39.15.
determination of the content of heavy metals analysis 1 7.90 1.42 9.32 39.16.
determination of the loss of mass on drying of 1 analysis 5.90 1.06 6.96 39.17.
determination of the quantity of water analysis 1 8.80 1.58 10.38 39.18.
the determination analysis of decomposition of 1 8.50 1.53 10.03 39.19.
determination of nobirzum 1 analysis 3.60 0.65 4.25 39.20.
determination of the dissolution (without further quantitative analysis concerned) 1 analysis 25.50 4.59 30.09 39.21.
solid dosage forms of analysis for the determination of hardness 1 4.60 0.83 5.43 39.22.
solid pharmaceutical form size 1 analysis 4.60 0.83 5.43 No 39.23.
1 analysis of osmolality 4.00 0.72 4.72 39.24.
determination of viscosity 1 analysis 12.70 2.29 14.99 39.25.
the active substance of uniformity: 39.25.1.
using titration analysis 55.60 10.01 65.61 39.25.2 1.
using the spectrophotometry analysis 61.10 11.00 72.10 39.25.3 1.
through the analysis of polarimetrij 1 39.25.4 39.00 7.02 46.02.
using high-performance liquid chromatography (AEŠH) 1 analysis 89.60 16.13 105.73 39.25.5.
using gas chromatography (GC) analysis 62.50 11.25 73.75 39.25.6 1.
using atomabsorbcij spectrometry (AAS) analysis 1 89.50 16.11 105.61 39.26.
quantitative determination of the content: 39.26.1.
using titration analysis 22.40 4.03 26.43 39.26.2 1.
using the spectrophotometry analysis 34.30 6.17 40.47 39.26.3 1.
through the analysis of polarimetrij 1 39.26.4 16.20 2.92 19.12.
using high-performance liquid chromatography (AEŠH) 1 analysis 62.60 11.27 73.87 39.26.5.
using gas chromatography (GC) analysis 36.40 6.55 42.95 39.26.6 1.
using atomabsorbcij spectrometry (AAS) analysis 57.80 10.40 68.20 1 39.27.
sterility testing: 1 analysis 15.00 2.70 17.70 39.28.
microbiological purity 1 determining analysis 45.00 8.10 53.10 40.
Pharmaceutical quality control analysis and design of Protocol translation in English 1 Protocol 15.00 2.70 17.70 41.
Purified water quality control sample 10.00 1.80 11.80 42 1.
Copying a document 1 page 43 0.09 0.02 0.11.
Drug consumption data provision 1 parameter 9.63 1.73 11.36 44.
Reconciliation reports on the distribution of free samples of medicinal products 1 10.00 1.80 11.80 45.
Reconciliation of remaining inventory for distribution, or when the product is not re-registered the renewal has been refused for 1 medicine 10.00 1.80 11.80 46.
Latvian medicine registry Gazette 1 book 2.97 0.53 3.50 47.
Drug consumption statistics published 1 book 9.32 1.68 11.00 Health Minister g. Smith