Amendment Of The Cabinet Of Ministers Of 17 January 2006 Rules No 61 "regulations On The State Agency Of Medicines Of The Public Paid Services Price List"

Original Language Title: Grozījums Ministru kabineta 2006.gada 17.janvāra noteikumos Nr.61 "Noteikumi par Zāļu valsts aģentūras publisko maksas pakalpojumu cenrādi"

Read the untranslated law here: https://www.vestnesis.lv/ta/id/157381

Cabinet of Ministers Regulations No. 321 in 2007 (15 May. No 29 5) amendment of the Cabinet of Ministers of 17 January 2006 rules No 61 "regulations on 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 paragraph of article 5 to make the Cabinet on 17 January 2006, rules No 61 "regulations on the State Agency of medicines of the public paid services price list" (Latvian journal, 2006, nr. 20) and make the following attachments : "The Cabinet of Ministers of 17 January 2006, the Regulation No 61 of the State Agency of Medicines a public charge service price list no BC public service unit price without VAT (Ls) SALES TAX ($) price with VAT (Ls) 1. Inspection of medicinal products: the first proposed 1.1. pharmaceutical form and strength: expertise 1200.00 0.00 1200.00 1.1.1. pharmaceutical form for each additional expertise for 600.00 0.00 600.00 1.1.2. for each additional strength for inspection 400.00 0.00 400.00 1.2. homeopathic medicinal products with a reasonable medical indications and used in diagnosis: inspection 170.00 0.00 170.00 1.2.1. dosage forms for each additional expertise to 80.00 0.00 80.00 1.3. homeopathic medicinal products without medical indications (simplified registration procedure) inspection 100.00 0.00 100.00 1.4. traditional herbal medicinal products: inspection 1.4.1. additional 400.00 0.00 400.00 each pharmaceutical form for inspection 200.00 0.00 200.00 1.4.2. each additional strength to the inspection inspection 2 80.00 0.00 80.00 registration of medicinal products : one of the medicinal product 2.1 form and strength: expertise 470.00 0.00 470.00 2.1.1. each additional dosage forms for inspection 240.00 0.00 240.00 2.1.2. each additional strength expertise to 90.00 0.00 90.00 2.2. homeopathic medicinal products with a reasonable medical indications and used diagnostic inspection 90.00 0.00 90.00 2.3. homeopathic medicinal products with medical indications (simplified registration procedure) inspection 50.00 0.00 50.00 2.4. traditional herbal medicinal products : expertise 240.00 0.00 240.00 2.4.1. pharmaceutical form for each additional expertise to 120.00 0.00 120.00 2.4.2. for each additional strength of expertise 3. Changes of 120.00 0.00 120.00 registration documentation and issuing a duplicate certificate of registration *: 3.1 (I) type inspection 100.00 0.00 100.00 3.2 I B type inspection 150.00 0.00 150.00 3.3. Type II changes that require an in-depth scientific evaluation expertise 300.00 0.00 300.00 3.4. Type II changes , which do not require an in-depth scientific evaluation expertise 100.00 0.00 100.00 3.5. registration certificate holder (owner) changes due to exchange expertise 100.00 0.00 100.00 3.6. changes in the instructions for use or on the label that are not related to changes in the summary of inspection 3.7. registration certificate of 100.00 0.00 100.00 duplicate registration certificate of issue of 50.00 0.00 50.00 4. Inspection for the registration of the medicinal product, the mutual-recognition procedure and the decentralised procedure, in which Latvia is responsible (reference) * : the first proposed 4.1 pharmaceutical form and strength: expertise 2000.00 0.00 2000.00 4.1.1. each additional dosage forms for inspection 1200.00 0.00 1200.00 4.1.2 for each additional strength to the expertise of the evaluation of the medicinal product 600.00 0.00 600.00 4.1.3. report evaluation report 800.00 0.00 800.00 4.2. medicines used in diagnosis: inspection 1000.00 0.00 1000.00 4.2.1. each additional dosage forms for inspection 800.00 0.00 800.00 4.2.2. each additional strength to 500.00 0.00 500.00 expertise 4.3. traditional herbal medicinal products : expertise 1200.00 0.00 1200.00 4.3.1. each additional dosage forms for inspection 800.00 0.00 800.00 4.3.2. each additional strength to 400.00 0.00 400.00 5. expertise expertise for marketing mutual registration recognition procedure and the decentralised procedure, in which Latvia is participating: 1000.00 0.00 1000.00 5.1 expertise for each additional dosage forms for inspection 600.00 0.00 600.00 5.2 for each additional strength for inspection 6. Medicinal 400.00 0.00 400.00 post-registration monitoring (year) * : each registered 6.1. pharmaceutical form and strength, except this list referred to in point 6.2 Hall registration number 6.2. traditionally used 350.00 0.00 350.00 herbal medicines and medicines that are used in diagnosis registration number of every registered 6.3 100.00 0.00 100.00 homeopathic medicine with reasonable medical indications registration number 6.4.100.00 0.00 100.00 registered homeopathic medicine without medical indications (simplified registration) registration number 30.00 0.00 30.00 7. evaluation product documentation to determine its conformity with the definition of a medicinal product shall: 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 of product exposure 60.00 0.00 60.00 7.2. physiological function and medical examination of inspection indicating 240.00 0.00 240.00 8. Medicine import, export and distribution authorisation and renewal *: 8.1. authorization for imports of the product in Latvia from third countries and distribution: 8.1.1. first record of medicinal products authorised in the permit 30.00 0.00 30.00 8.1.2. each subsequent entry in the authorisation of medicinal products authorised 10.00 0.00 10.00 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 0.00 15.00 8.2.2. If you changed the data for the permit holder or drug dealer change 8.00 0.00 8.00 9. Authorisation of parallel distribution of medicinal products imported into Latvia and changes in permissions: permission 211.87 0.00 211.87 9.1. changes in the package leaflet of the medicinal product inspection 50.00 0.00 50.00 9.2. changes in the labelling of the medicinal product inspection 50.00 0.00 50.00 9.3. changes to permit inspection 50.00 0.00 50.00 10. Authorisation of investigational medicinal products (clinical study of the preparation for the import or export in Latvia) of Latvia: 10.1 the first entry in the authorisation of medicinal products authorised 17.00 0.00 17.00 10.2. each subsequent entry in the authorisation of medicinal products authorised 7.75 0.00 7.75 11. Authorisation for the import 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 authorization of 0.17 0.00 0.17 12. unregistered importation of medicines (pharmaceutical law article 7, point "b" and "c" in the cases referred to in point) 12.1. the first medicine: entry permit authorization 5.00 0.00 5.00 12.2. each subsequent entry in the authorisation of medicinal products authorised 1.00 0.00 1.00 13. Authorisation of medicinal products not registered for distribution in Latvia (pharmaceutical law article 7, point "b" and "c" in the cases referred to in subparagraph): 13.1. first record of medicinal products authorised in the permit 15.00 0.00 15.00 13.2. each subsequent entry in the authorisation of medicinal products authorised 4.75 0.00 4.75 14. Authorisation for registration of medicinal products , or renewal of approval of changes in the documentation for the marketing of medicinal products for the import of a single sample or removal from Latvia Latvia: 14.1 to five entries in the authorisation of medicinal products authorised 5.00 0.00 5.00 14.2. each subsequent entry in the authorisation of medicinal products authorised 1.00 0.00 1.00 15. Pharmaceutical or veterinārfarmaceitisk activities company conformity assessment the supervisory expertise in the following cases: 15.1 the trader's legal status or change the type of merchant, and the merchant company of discretionary transfers of part 1 inspection 30.00 0.00 30.00 15.2. pharmacy manager or veterinary medicinal products or medicinal products of lieltirgotav officers whether the medicine or veterinary medicine production company change of qualified person 1 inspection 30.00 0.00 30.00 15.3. pharmaceutical or veterinārfarmaceitisk activities company restore or special operating conditions or particular medicine or veterinary medicine production or import of 1st renewal inspection 30.00 0.00 30.00 16. Good manufacturing practice for medicinal products the issue of the certificate, the certificate 17. Pharmaceutical activities 100.00 0.00 100.00 company conformity assessment: 17.1. General types of pharmacies : 17.1.1. If a pharmacy is located in the city 1. pharmacy 80.00 0.00 80.00 17.1.2 if pharmacy is located in the city and it is one branch of Pharmacy and 1 branch 70.00 0.00 70.00 17.1.3. If a pharmacy is located in the city and has two branches and 2 branches of Pharmacy 17.1.4. If a pharmacy is 60.00 0.00 60.00 fields 1 pharmacy pharmacy is 30.00 0.00 30.00 17.1.5. when the fields and it has one branch 1 pharmacy pharmacy is 35.00 0.00 35.00 17.1.6. If fields and has two branches 1 Pharmacy 40.00 0.00 40.00 17.2. closed type pharmacy pharmacy 30.00 0.00 30.00 17.3.1 one branch pharmacies, if it is not necessary to carry out the assessment of conformity with the pharmacy branch 20.00 0.00 20.00 17.4.1 drug lieltirgotav (good distribution practice) 1 lieltirgotav of medicine medicine lieltirgotav 17.5.200.00 0.00 200.00 divisions (good distribution practice) 1 Medicine Department of 50.00 0.00 50.00 10.9. lieltirgotav pharmaceutical company (good manufacturing practice) 1 pharmaceutical company 300.00 0.00 300.00 18.

Conformity assessment for the production of medicines in pharmacies: 18.1. If a pharmacy is located in the city of 1 drugstore 40.00 0.00 40.00 18.2. closed type pharmacy or pharmacies, located in fields 1 pharmacy 20.00 0.00 20.00 19. Conformity assessment for the manufacture of medicinal products (medicinal products, repackaging and packaging) 1 lieltirgotav lieltirgotav of medicinal products in the medicine videoreklām 20 100.00 0.00 100.00 evaluation *: 1 promotional material for the evaluation of the accelerated 80.00 0.00 80.00 20.1. within 10 working days after the receipt of the material required 1 promotional material for accelerated evaluation 160.00 0.00 160.00 20.2. within five working days after the required material receive 1 promotional material 320.00 0.00 320.00 20.3. 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 accelerated evaluation 20.00 0.00 20.00 20.3.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 40.00 0.00 40.00 20.3.2. within five working days after the receipt of the material required 1 promotional material 80.00 0.00 80.00 20.4. 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 for the evaluation of the accelerated 30.00 0.00 30.00 20.4.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 60.00 0.00 60.00 20.4.2. within five working days after the receipt of the material required 1 promotional material for deploying to 120.00 0.00 120.00 20.5. conveyor belts in medicine videoreklām beforehand for information evaluation : 1 promotional material for the evaluation of the accelerated 10.00 0.00 10.00 20.5.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 20.00 0.00 20.00 20.5.2. within five working days after the receipt of the material required 1 promotional material 40.00 0.00 40.00 21. Drug Evaluation of the collection videoreklām: 1 promotional material for the evaluation of the accelerated 10.00 0.00 10.00 21.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 20.00 0.00 20.00 21.2. within five working days after the receipt of the material required 1 promotional material 40.00 0.00
22. Audioreklām evaluation of 40.00 *: 1 promotional material for the evaluation of the accelerated 50.00 0.00 50.00 22.1. within 10 working days after the receipt of the material required 1 promotional material for accelerated evaluation 100.00 0.00 100.00 22.2. within five working days after the receipt of the material required 1 promotional material 200.00 0.00 200.00 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 fact referred to in advertising : 1 promotional material for accelerated evaluation 20.00 0.00 20.00 22.3.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 40.00 0.00 40.00 22.3.2. within five working days after the receipt of the material required 1 promotional material 80.00 0.00 80.00 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 for the evaluation of the accelerated 30.00 0.00 30.00 22.4.1. within 10 working days after the receipt of the material required 1 promotional material 60.00 0.00
22.4.2. speed up evaluation of 60.00 within five working days after the receipt of the material required 1 promotional material 120.00 0.00 120.00 23. Drug Evaluation of the collection audioreklām: 1 promotional material for the evaluation of the accelerated 10.00 0.00 10.00 23.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 20.00 0.00 20.00 23.2. within five working days after the receipt of the material required 1 promotional material Written ads 40.00 0.00 40.00 24. evaluation (one medicinal product) : 1 promotional material for accelerated evaluation 30.00 0.00 30.00 24.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 60.00 0.00 60.00 24.2. within five working days after the receipt of the material required 1 promotional material 120.00 0.00 120.00 24.3. for more information on the 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 review 24.3.1. accelerated 20.00 0.00 20.00 10 working days after the receipt of the material required 1 promotional material 40.00 0.00 40.00 24.3.2.
accelerated examination within five working days after the receipt of the material required 1 promotional material 80.00 0.00 80.00 24.4. for more information on the 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 for the evaluation of the accelerated 30.00 0.00 30.00 24.4.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 60.00 0.00 60.00 24.4.2. within five working days after the receipt of the material required 1 promotional material 120.00 0.00 120.00 24.5. evaluation of information, 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 for the evaluation of the accelerated 50.00 0.00 50.00 24.5.1. within 10 working days after the receipt of the material required 1 promotional material for accelerated evaluation 100.00 0.00 100.00 24.5.2. within five working days after the receipt of the material required 1 promotional material 200.00 0.00 200.00 24.6. 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 for the evaluation of the accelerated 80.00 0.00 80.00 24.6.1. within 10 working days after the receipt of the material required 1 160.00 0.00 160.00 24.6.2. promotional material accelerated examination within five working days after the receipt of the material required 1 320.00 0.00 320.00 promotional material 25. Previously approved written evaluation of changes of the ad (up to 200 characters) * : 1 promotional material for accelerated evaluation 10.00 0.00 10.00 25.1. within 10 working days after the receipt of the material required 1 promotional material for accelerated evaluation 20.00 0.00 20.00 25.2. within five working days after the receipt of the material required 1 promotional material written reminder 40.00 0.00 40.00 26 advertising evaluation (drugs): 1 promotional material for the evaluation of the accelerated 5.00 0.00 5.00 26.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 10.00 0.00 10.00 26.2. within five working days after the receipt of the material required 1 promotional material
27.20.00 0.00 20.00 submitted advertising material conformity of the information contained in the status review of the advertising of a medicinal product shall: (1) promotional material for the evaluation of the accelerated 30.00 0.00 30.00 27.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 60.00 0.00 60.00 27.2. within five working days after the receipt of the material required 1 promotional material 120.00 0.00 120.00 28. videoreklām medicinal the agreed evaluation for extension of authorization : 1 promotional material for accelerated evaluation 30.00 0.00 30.00 28.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 60.00 0.00 60.00 28.2. within five working days after the receipt of the material required 1 promotional material 120.00 0.00 120.00 29. audioreklām medicinal the agreed consideration for the extension of the authorisation: 1 promotional material for the evaluation of the accelerated 20.00 0.00 20.00 29.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 40.00 0.00 40.00 29.2. within five working days after the receipt of the material required 1 promotional material 30.80.00 0.00 80.00 beforehand written advertising medicinal products evaluation allows for extension: 1 promotional material for accelerated evaluation 10.00 0.00 10.00 30.1. within 10 working days after the receipt of the material required 1 promotional material for the evaluation of the accelerated 20.00 0.00 20.00 30.2. within five working days after the receipt of the material required 1 promotional material 31.40.00 0.00 40.00 medicine clinical trial application and review of documentation 1 800.00 0.00 800.00 expertise 32. Medicine clinical trial protocol review Amendment 1 120.00 0.00 120.0

33. Drug manufacturer (representative of) the proposed use of the observation application and attached documents 1 150.00 0.00 150.00 expertise examination 34. nark issue and the illegal psychotropic substances and drugs, as well as precursors to importation or exportation 1.35 * permission 15.00 0.00 15.00 product certificate 1 a certificate of Service Information 36.65.00 0.00 65.00 from the Latvian drug registry database 1 year subscription 152.16 27.39 179.55 37. quality control of medicinal products * : 37.1.

identity of the medicinal product: 37.1.1. through a chemical reaction 1 8.00 0.00 8.00 37.1.2. using the analysis of instrumental methods and thin-layer chromatography (PSH) 1 analysis determination of clarity 20.50 0.00 20.50 37.2. Analysis 1 color conformity 3.40 0.00 3.40 37.3. Discovery 1 analysis determination of solubility 3.40 0.00 3.40 37.4.1 analysis pH determination 1 3.40 0.00 3.40 37.5. analysis of the density determination of 6.90 0.00 6.90 23.4.1 analysis 7.60 0.00 7.60 37.7. refractive index detection analysis 3.40 0.00 3.40 23.5 1. melting point determination 1 analysis of the optical rotational 8.40 0.00 8.40 23.5. setting 1 analysis 9.30 0.00 9.30 37.10. mechanical impurities: Visual analysis 37.10.1 1 37.10.2 1 6.10 0.00 6.10. instrumental analysis 9.30 0.00 9.30 37.11. determination of impurities: 37.11.1. using the maintenance methods of test 1 37.11.2 6.70 0.00 6.70. analysis using thin-layer chromatography (PSH) 1 analysis 26.50 0.00 26.50 37.12. determination of nominal volume 1 analysis 1.20 0.00 1.20 37.13. average weight and the deviations from the mean weight determination 1 analysis 4.20 0.00 4.20 37.14. sulphate ash analysis of quantification 1 7.90 0.00 7.90 37.15. heavy metal content analysis 7.90 0.00 7.90 37.16 1. determination of the loss of mass on drying of 1 analysis 5.90 0.00 5.90 37.17. determination of the quantity of water analysis 1 8.80 0.00 8.80 37.18. determination of the decomposition analysis 8.50 0.00 8.50 1. nobirzum detection of 37.19 analysis 1. dissolution determination of 3.60 0.00 3.60 37.20 (without further analysis of relevant quantitative) analysis 25.50 0.00 25.50 37.21 1. solid pharmaceutical form of analysis for the determination of hardness 1 4.60 0.00 4.60 37.22. solid pharmaceutical form analysis of size 1. determination of 4.60 0.00 4.60 37.23 osmolality 1 analysis 4.00 0.00 4.00 37.24. determination of viscosity 1 analysis 12.70 0.00 12.70 37.25. active substances content uniformity: 37.25.1. by using titration 1 analysis using spectrophotometry 55.60 0.00 55.60 37.25.2.1 37.25.3. through the analysis of 61.10 0.00 61.10 polarimetrij 1 analysis using high 37.25.4 39.00 0.00 39.00. effective liquid chromatography (AEŠH) 1 37.25.5 89.60 0.00 89.60. analysis using gas chromatography (GC) analysis using atomabsorbcij-37.25.6.62.50 0.00 62.50 spectrometry (AAS)
1. quantitative analysis of contents 89.50 0.00 89.50 37.26 detection: 37.26.1. by using titration 1 analysis using spectrophotometry 22.40 0.00 22.40 37.26.2.1 37.26.3. through the analysis of 34.30 0.00 34.30 polarimetrij 1 analysis using high 37.26.4 16.20 0.00 16.20. effective liquid chromatography (AEŠH) 1 37.26.5 62.60 0.00 62.60. analysis using gas chromatography (GC) analysis using the 37.26.6. atomabsorbcij-36.40 0.00 36.40 spectrometry (AAS) analysis 57.80 0.00 57.80 37.27 1. sterility test 1 analysis microbiological purity 15.00 0.00 15.00 37.28. Discovery 1 analysis 45.00
38.0.00 45.00 medicine quality control analysis and design of Protocol translation in English 1 protocol 39.15.00 2.70 17.70 Purified Water quality control 1 copy of documents 40.10.00 1.80 11.80 1 page 41. Medicines consumption 0.09 0.02 0.11 data * 1 parameter 42 9.63 0.00 9.63. Reconciliation of remaining stocks of medicines for distribution, or when the product is not re-registered the renewal has been refused on 1 medication medicine 43.10.00 0.00 10.00 registry Gazette 1 book 44. Medicinal 2.97 0.53 3.50 consumption expenditure statistics of 1 book 9.32 1.68 11.00 45. Examinations for registration of veterinary medicinal products: 45.1. the first proposed medicine form and strengths: expertise 45.1.1.500.00 0.00 500.00 for each additional dosage forms of inspection for each additional 250.00 0.00 250.00 45.1.2. drug strength inspection 170.00 0.00 170.00 45.2. homeopathic medicinal products inspection 150.00 0.00 150.00 46. Examination for registration of veterinary medicinal products: 46.1. one pharmaceutical form and strength: expertise 300.00 0.00 300.00 46.1.1. pharmaceutical form for each additional expertise for every additional 150.00 0.00 150.00 46.1.2. drug strength inspection 90.00
0.00 90.00 46.2. homeopathic medicinal products inspection 90.00 0.00 90.00 47. Changes in registration of veterinary medicinal products and the issue of a duplicate certificate of registration *: 29.3. (I) the type of inspection type I B 100.00 0.00 100.00 47.2. change inspection 150.00 0.00 150.00 47.3. Type II variation that evaluation requires in-depth scientific evaluation expertise 300.00 0.00 300.00 47.4. Type II changes that do not require in-depth assessment of scientific evaluation expertise 100.00 0.00 100.00 29.5. the registration certificate holder (owner) changes due to exchange expertise 100.00 0.00
100.00 29.6. changes in the instructions for use or on the label that are not related to changes in the summary of the expertise of the registration certificate, 29.6 100.00 0.00 100.00. issue of duplicate registration certificate 50.00 0.00 50.00 48. Examination for registration of veterinary medicinal products, the mutual recognition procedure and decentralised procedure in which Latvia is participating: inspection 1000.00 0.00 1000.00 29.9. pharmaceutical form for each additional expertise for every additional 600.00 0.00 600.00 48.2. drug strength inspection 400.00 0.00 400.00 49. post-registration monitoring of veterinary medicines (year) * : 30.5. each registered pharmaceutical form and strength of the registration number of every registered 350.00 0.00 350.00 30.6. homeopathic veterinary medicinal products registration number 100.00 0.00 100.00 50. Veterinary medicinal products good manufacturing practices document evaluation and the issue of the certificate, the certificate is 51. steps Veterinārfarmaceitisk 100.00 0.00 100.00 company conformity assessment: 51.1. lieltirgotav veterinary medicinal product conformity assessment 1 lieltirgotav of veterinary medicine veterinary medicine 200.00 0.00 200.00 51.2. lieltirgotav Department of conformity assessment of veterinary medicinal products 1, lieltirgotav section 51.3. veterinary medicinal products 50.00 0.00 50.00 production company conformity assessment 1 veterinary pharmaceutical company 300.00 0.00 300.00 52. Fee for the provision of good manufacturing practice for medicinal products test the production or importation of enterprise: 52.1. If labour inspection in one day (one officer) 1 pharmaceutical company 123.41 0.00 123.41 52.2. If labour inspection in two days (one officer) 1 pharmaceutical company 156.32 0.00 156.32 52.3. If labour inspection object is three days (one officer) 1 pharmaceutical company 189.23 0.00 189.23 52.4. If labour inspection object contains four days (one Inspector) 1 pharmaceutical company 222.14 0.00 222.14 52.5. If labour inspection object has five days (one officer) 1 pharmaceutical company 255.05 0.00 255.05 53. Inspection for the registration of veterinary medicinal products, mutual recognition of registration and the decentralised procedure, in which Latvia is responsible (reference) national: inspection 2000.00 0.00 2000.00 53.1. each additional dosage forms for inspection 1200.00 0.00 1200.00 53.2. for each additional strength to 54 600.00 0.00 600.00 expertise. Fee for the provision of good manufacturing practice test at the request of the manufacturer of the medicinal products the raw materials for manufacture or import into the enterprise: 54.1. If labour inspection in one day (one officer) 1 pharmaceutical company 152.59 0.00 152.59 54.2. If labour inspection in two days (one officer) 1 pharmaceutical company 190.66 0.00 190.66 54.3. If labour inspection object has three days (one officer) 1 pharmaceutical company 230.14 0.00 230.14 54.4. If labour inspection object contains four days (one officer) 1 pharmaceutical company 261.16 0.00 261.16 54.5.
If labour inspection object has five days (one officer) 1 pharmaceutical company 305.08 0.00 305.08 55. Manufacture or import into the company's qualified person's education and professional experience of the law conformity assessment requirements of the manufacture of medicinal products 1 person 70.00 0.00 70.00 56. document good manufacturing practice-shop description and submission procedure for the evaluation of the pharmaceutical company, which is not located in a Member State of the European Union * 1 150.00 0.00 150.00 pharmaceutical company 57. Drug sampling testing * 1 drug sample medicine 3.00 0.00 3.00 58. quality control: 58.1. identity of the medicinal product: 58.1.1. external features (medicinal plant Drogas) 1 analysis 58.1.2 1.70 0.00 1.70. microscopy (medicinal plant Drogas) 1 analysis determination of impurities 7.20 0.00 7.20 58.2. medicinal plant-1 analysis of the drog 6.30 0.00 6.30 58.3. quantitative determination of the content of the substances ekstraktīv 58.3.1.: the content of medicinal plants in 58.3.2 drog analysis 1 24.70 0.00 24.70. essential substance content of medicinal plant-1 analysis of the drog 24.70 0.00 24.70 58.4. medicinal plant, the degree of grinding 1 drog analysis 59. Purified Water 3.30 0.00 3.30 quality control (pharmacies) 1 60. Titrated solution of 15.00 2.70 17.70, indicators, and preparation of reagent 1 name pharmacies 3.00 0.00 3.00 61. Water microbiological purity control analysis 5.00 0.90 5.90 1 "


Note the. * Value added tax shall be applied in accordance with the law "on value added tax" in article 2 of the twenty-second part.
Prime Minister a. Halloween health ministers-cultural Minister h. demakova