Noteikumi Par Zāļu Valsts Aģentūras Publisko Maksas Pakalpojumu Cenrādi

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

Price excl. Price incl. VAT # Description of Service Unit PVN VAT(LVL (LVL) (LVL) ) 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 Application 10 000.00 0.00 10 000.00 (except Subparagraphs 1.1.2 and 1.1.3) 1.1.2. Medicines containing a fixed combination of Application 4 000.00 0.00 4 000.00 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 1.1.3. Basically similar medicines – generic Application 3 000.00 0.00 3 000.00 medicines, compound registration application 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 Application 2 000.00 0.00 2 000.00 of an active substance with another salt, ester complex or isomer if their action and safety characteristics do not differ significantly 1.3. Each additional strength (concentration) or Application 1 000.00 0.00 1 000.00 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 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 Application 1 000.00 0.00 1 000.00 indications 1.6. Homeopathic medicines without therapeutic Application 400.00 0.00 400.00 indications by a simplified registration procedure 1.7. Anthroposophic medicines, which are Application 400.00 0.00 400.00 described in officially used pharmacopoeia and produced using a homeopathic method 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 Application 500.00 0.00 500.00 commercial packaging of a medicine, 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 2.2. Traditionally used phytogenic medicines Application 600.00 0.00 600.00 2.3. Homeopathic medicines with therapeutic Application 500.00 0.00 500.00 indications 2.4. Homeopathic medicines without therapeutic Application 200.00 0.00 200.00 indications (registered by a simplified registration procedure) 3. Regularly updated safety report expertise of Report 1 000.00 0.00 1 000.00 medicines registered by the national procedure - for one medicine* 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- One change 300.00 0.00 300.00 depth evaluation of research documentation 4.4. Significant changes of Type II not requiring an One change 100.00 0.00 100.00 in-depth evaluation of research documentation 4.5. Significant changes of Type II related with the One change 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) 4.6. Changes in user instructions or marking (not One change 100.00 0.00 100.00 related to changes in the medicine description) 5. Expert’s assessment of an application and the enclosed documentation for registration of medicinal 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 5.3. Each additional strength (concentration) or Application 600.00 0.00 600.00 commercial packaging of a medicine, 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 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 6. Expert’s assessment of an application and the enclosed documentation for registration of medicinal 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 Application 4 000.00 0.00 4 000.00 combination, for similar medicines of biological origin or widely used medicines 6.1.3. Basically similar medicines – generic Application 3 000.00 0.00 3 000.00 medicines, compound registration application or other application 6.2. Each extra medicinal form Application 2 000.00 0.00 2 000.00 6.3. Each additional strength (concentration) or Application 1 000.00 0.00 1 000.00 commercial packaging of a medicine, 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 6.4. For procedure (in addition to Subparagraphs Procedure number 9 000.00 0.00 9 000.00 6.1, 6.2 and 6.3 hereof) 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

7.1.2. Each additional strength (concentration) or Application 500,00 0,00 500,00 commercial packaging of a medicine, 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 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 8.1.2. Each additional strength (concentration) or Application 1 000.00 0.00 1 000.00 commercial packaging of a medicine, 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 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 9.1.2. Each extra medicinal form Application 1 000.00 0.00 1 000.00 9.1.3. Each additional strength (concentration) or Application 500.00 0.00 500.00 commercial packaging of a medicine, 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 9.1.4. For procedure (in addition to Subparagraphs Procedure number 3 000.00 0.00 3 000.00 9.1.1, 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 9.2.2. Each extra medicinal form Application 1 000.00 0.00 1 000.00 9.2.3. Each additional strength (concentration) or Application 500.00 0.00 500.00 commercial packaging of a medicine, 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 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 Procedure number 1 000.00 0.00 1 000.00 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 11.3. Significant changes of Type II requiring an in- One change 300.00 0.00 300.00 depth evaluation of research documentation 11.4. Significant changes of Type II not requiring an One change 100.00 0.00 100.00 in-depth evaluation of research documentation 11.5. Significant changes of Type II related with the One change 100.00 0.00 100.00 change of a registration certificate holder 11.6. Changes in user instructions or marking (not One change 100.00 0.00 100.00 related to changes in the medicine description) 11.7. For procedure if Latvia is the responsible (reference) state 11.7.1. Significant changes of Type II requiring an in- One change 600.00 0.00 600.00 depth scientific evaluation of documentation 11.7.2. Other changes except those mentioned in One change 300.00 0.00 300.00 Subparagraph 11.7.1 hereof 12. Post-registration surveillance of medicines (per annum)* 12.1. Each registered medicinal form and strength Registration number 350.00 0.00 350.00 (concentration), except for the products mentioned in Paragraph 13 hereof 12.2. Traditionally used phytogenic medicines and Registration number 100.00 0.00 100.00 medicines used for diagnostic purposes 12.3. Homeopathic medicines with therapeutic Registration number 100.00 0.00 100.00 indications 12.4. Homeopathic medicines without therapeutic Registration number 30.00 0.00 30.00 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 Application 300.00 0.00 300.00 does not require in-depth scientific expertise 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 Expertise 211.87 0.00 211.87 distribution of medicinal products in Latvia that were imported in parallel and making amendments* 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 Expertise 50.00 0.00 50.00 registered office of an entrepreneur) 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 Expertise 0.50 0.00 0.50 document 15.2. each subsequent entry of medicine in a Expertise 0.50 0.00 0.50 document 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 Expertise 15.00 0.00 15.00 document 16.2. each subsequent entry of medicine in a Expertise 4.75 0.00 4.75 document 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 Expertise of 50.00 0.00 50.00 entrepreneur or transfer of title for any documentation of 1 constant parts (shares) of the entrepreneur’s pharmaceutical or business veterinary pharmaceutical enterprise 18.2. Replacement of a pharmacy manager, Expertise of 50.00 0.00 50.00 responsible officials of a wholesaler of documentation medicinal or veterinary products, or change of regarding 1 official 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) 18.3. Change of the name of an entrepreneur’s firm Expertise of 50.00 0.00 50.00 or a pharmaceutical or veterinary documentation of 1 pharmaceutical enterprise (if different from the pharmaceutical or firm’s name) veterinary pharmaceutical enterprise 18.4. Change of the registered office (legal address) Expertise of 50.00 0.00 50.00 of an entrepreneur documentation of 1 pharmaceutical or veterinary pharmaceutical enterprise 18.5. Change of the surname of an individual Expertise of 50.00 0.00 50.00 entrepreneur documentation regarding 1 official 18.6. In view of closing of a pharmacy affiliate or Expertise of 30.00 0.00 30.00 branch of a wholesaler of medicines or documentation of 1 veterinary medicines pharmaceutical or veterinary pharmaceutical enterprise 18.7. In view of suspension of a special permit Expertise of 30.00 0.00 30.00 (licence) to perform pharmaceutical or documentation of 1 veterinary pharmaceutical activities pharmaceutical or veterinary pharmaceutical enterprise 18.8. In view of suspension of operations of a Expertise of 30.00 0.00 30.00 pharmacy affiliate or a branch of wholesaler of documentation of 1 medicines or veterinary medicines pharmaceutical or veterinary pharmaceutical enterprise 18.9. In view of any amendments in the annex to a Expertise of 30.00 0.00 30.00 special permit (licence) for pharmaceutical or documentation of 1 veterinary pharmaceutical activity if no pharmaceutical or expert’s assessment of pharmaceutical or veterinary veterinary pharmaceutical activities is required pharmaceutical enterprise 18.10. Amendments to documents and information if Expertise of 30.00 0.00 30.00 no re-registration of a special permit (licence) documentation of 1 for pharmaceutical or veterinary pharmaceutical or pharmaceutical activity is required veterinary pharmaceutical enterprise 18.11. Renewal of a special permit (licence) for 1 expertise 50.00 0.00 50.00 pharmaceutical or veterinary pharmaceutical operations if no conformity evaluation of the pharmaceutical or veterinary pharmaceutical enterprise is required 18.12. Renewal of a special permit (licence) for Expertise of 30.00 0.00 30.00 pharmaceutical or veterinary pharmaceutical documentation of 1 operations, or renewal of any special activity pharmaceutical or conditions as provided for in the special permit veterinary (licence) for pharmaceutical or veterinary pharmaceutical pharmaceutical operations, or resumption of enterprise production or importing of any concrete medicine or veterinary medicine, if no conformity evaluation of the pharmaceutical or veterinary pharmaceutical enterprise is required 18.13. Expertise of the documents of a Expertise of 30.00 0.00 30.00 pharmaceutical or veterinary pharmaceutical documentation of 1 enterprise if it commences (carries out) pharmaceutical or production or importing of raw materials veterinary pharmaceutical enterprise 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 Expertise of 100.00 0.00 100.00 territory (in a city) documentation of 1 pharmacy 19.1.2. If a pharmacy is located in a city (town) and Expertise of 80.00 0.00 80.00 has one affiliate documentation of 1 pharmacy and its affiliate 19.1.3. If a pharmacy is located in a city (town) and Expertise of 70.00 0.00 70.00 has two affiliates documentation of 1 pharmacy and 2 affiliates 19.1.4. If a pharmacy is located in the country (rural Expertise of 50.00 0.00 50.00 territory) documentation of 1 pharmacy 19.1.5. If a pharmacy is located in the country and Expertise of 40.00 0.00 40.00 has one affiliate documentation of 1 pharmacy 19.1.6. If a pharmacy is located in the country and Expertise of 35.00 0.00 35.00 has two affiliates documentation of 1 pharmacy 19.2. Pharmacy of closed type Expertise of 45.00 0.00 45.00 documentation of 1 pharmacy and its affiliates 19.3. One pharmacy affiliate if no conformity Expertise of 35.00 0.00 35.00 evaluation of the pharmacy is required documentation of 1 affiliate 21. Appraisal of conformity of a pharmaceutical company (wholesaler or manufacture of medicinal products)* 21.1. Manufacturer or importer of medicinal Expertise of the 400,00 0,00 400,00 products documentation of 1 manufacturer or importer of medicinal products 21.2. Manufacturer of medicinal products Expertise of the 300,00 0,00 300,00 documentation of 1 manufacturer of medicinal products 21.3. Manufacturer of medicinal products (partial Expertise of the 300,00 0,00 300,00 production process) documentation of 1 manufacturer of medicinal products 21.4. Company only producing medicinal products Expertise of the 200,00 0,00 200,00 for trial documentation of 1 manufacturer of medicinal products 21.5. Wholesaler of medicinal products Expertise of the 300,00 0,00 300,00 documentation of 1 wholesaler 21.6. Department of a wholesaler of medicinal Expertise of the 70,00 0,00 70,00 products documentation of 1 wholesaler department 21.7. Manufacturer of active substances or Expertise of the 300,00 0,00 300,00 controllable medicines documentation of 1 manufacturer 21.8. Company engaged in ethyl alcohol filling Expertise of the 200,00 0,00 200,00" (packing) only documentation of 1 manufacturer or wholesaler of medicinal products 23. Preparation & printing of ordered materials 1 page 0,85 0,18 1,03 35. Reviewing of an application for a clinical 1 expertise 1 000,00 0,00 1 000,00 reserach of medicinal products and the enclosed documentation* 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 246,00 0,00 246,00 institutiton 35.1 2. Two days (one inspector) 1 clinical research centre/ related 312,00 0,00 312,00 institutiton 35.1 3. Three days (one inspector) 1 clinical research centre/ related 378,00 0,00 378,00 institutiton 35.1 4. Four days (one inspector) 1 clinical research centre/ related 444,00 0,00 444,00 institutiton 35.1 5. Five days (one inspector) 1 clinical research centre/ related 510,00 0,00 510,00 institutiton 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, in connection with medicinal product certificate submission for re-registration of the medicinal product* 35.2 1. One day (one inspector) 1 clinical research 450,00 0,00 450,00 centre/ related institutiton 35.2 2. Two days (one inspector) 1 clinical research centre/ related 570,00 0,00 570,00 institutiton 35.2 3. Three days (one inspector) 1 clinical research centre/ related 690,00 0,00 690,00 institutiton 35.2 4. Four days (one inspector) 1 clinical research centre/ related 780,00 0,00 780,00 institutiton 35.2 5. Five days (one inspector) 1 clinical research centre/ related 910,00 0,00 910,00 institutiton 36. Reviewing of amendments to the protocol of 1 amendment 150.00 0.00 150.00 clinical trial of a medicinal product* 37. Reviewing of an application and the enclosed 1 expertise 200.00 0.00 200.00 documents regarding surveillance of the use of a medicinal product submitted on the initiative of the manufacturer of the medicinal product (its representative)* 38. Expertise of an application and the enclosed Expertise 15.00 0.00 15.00 documentation for import/export of psychotropic and narcotic substances, as well as precursors* 39. Annual fee for receipt of information from the Subscription for 1 182.60 38.35 220.95 database of the Latvian Register of Medicines year 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 1 test 26.65 0.00 26.65 chromatography (TLC) 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 1 test 5.46 0.00 5.46 from the mean mass 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 1 test 33.15 0.00 33.15 relevant quantitative analysis) 40.21. Determination of hardness of solid medicinal 1 test 5.98 0.00 5.98 forms 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 1 test 116.48 0.00 116.48 chromatography (HPLC) 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 1 test 81.38 0.00 81.38 chromatography (HPLC) 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 1 protocol 19.50 3.51 23.01 and presentation in English 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 1 test 8.19 0.00 8.19 herbal medicines 42.3. Determination of quantitative content 42.3.1. extractive substances content in therapeutic 1 test 32.11 0.00 32.11 herbal medicines 42.3.2. ether substances content in therapeutic herbal 1 test 32.11 0.00 32.11 medicines 42.4. Therapeutic herbal medicine comminution 1 test 4.29 0.00 4.29 level 43. Purified water quality control (in pharmacies) 1 sample 19.50 4.10 23.60 44. Preparation of titrated liquids, indicators and 1 name 3.90 0.00 3.90 reagents for pharmacies* 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 1 expert’s opinion 50.00 0.00 50.00 request* 48. Provision of data on consumption of 1 parameter 9.63 0.00 9.63 medicines* 49. Product expertise for distribution of remaining stocks of medicinal products* 49.1. Medicines were not re-registered or their re- for 1 medicine 10,00 0,00 10,00 registration was declined 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 Application 700,00 0,00 700,00 strength 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 52.3. Significant changes of Type II requiring an in- Application 300.00 0.00 300.00 depth evaluation of research documentation 52.4. Significant changes of Type II not requiring an Application 100.00 0.00 100.00 in-depth evaluation of research documentation 52.5. Significant changes of Type II related with the 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) 52.6. Changes in user instructions or marking (not Application 100.00 0.00 100.00 related to changes in the medicine description) 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 Application 400.00 0.00 400.00 packaging of a medicine, 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 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 packaging of a medicine, 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 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 Application 200,00 0,00 200,00 packaging of a medicine, 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 53.2 1.4. For a procedure (in addition to Subparagraphs Procedure number 1500,00 0,00 1500,00 53.2 1.1, 53.2 1.2 and 53.2 1.3) 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 packaging of a medicine, 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 54. Veterinary medicine post-registration surveillance (per annum)* 54.1. each registered medicine’s form and strength Registration number 350.00 0.00 350.00 (concentration) 54.2. each registered homeopathic veterinary Registration number 100.00 0.00 100.00 medicine 55. Appraisal of documents relating to good Expertise 100.00 0.00 100.00 veterinary manufacturing practice* 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 veterinary medicines veterinary medicines 56.2. Appraisal of conformity of a branch of a 1 branch of a 70.00 0.00 70.00 wholesaler of veterinary medicines wholesaler of veterinary medicines 56.3. Appraisal of conformity of an enterprise of a 1 enterprise of a 400.00 0.00 400.00 wholesaler of veterinary medicines wholesaler of veterinary medicines 56.4. Appraisal of conformity of veterinary 1 medicines or 300.00 0.00 300.00 medicines production (partial production veterinary medicines process) enterprise production enterprise 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 246.00 0.00 246.00 veterinary medicines production enterprise 57.2. Two days (one inspector) 1 medicines or 312.00 0.00 312.00 veterinary medicines production enterprise 57.3. Three days (one inspector) 1 medicines or 378.00 0.00 378.00 veterinary medicines production enterprise 57.4. Four days (one inspector) 1 medicines or 444.00 0.00 444.00 veterinary medicines production enterprise 57.5. Five days (one inspector) 1 medicines or 510.00 0.00 510.00 veterinary medicines production enterprise 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 veterinary medicines production enterprise 57.1 2. Two days (one inspector) 1 medicines or 468,00 0,00 468,00 veterinary medicines production enterprise 57.1 3. Three days (one inspector) 1 medicines or 567,00 0,00 567,00 veterinary medicines production enterprise 57.1 4. Four days (one inspector) 1 medicines or 666,00 0,00 666,00 veterinary medicines production enterprise 57.1 5. Five days (one inspector) 1 medicines or 765,00 0,00 765,00 veterinary medicines production enterprise 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 Application 600.00 0.00 600.00 packaging of a veterinary medicine, 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 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 Application 600.00 0.00 600.00 packaging of a veterinary medicine, 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 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 305.00 0.00 305.00 enterprise 59.2. Two days (one inspector) 1 medicines production 381.00 0.00 381.00 enterprise 59.3. Three days (one inspector) 1 medicines production 460.00 0.00 460.00 enterprise 59.4. Four days (one inspector) 1 medicines production 522.00 0.00 522.00 enterprise 59.5. Five days (one inspector) 1 medicines production 610.00 0.00 610.00 enterprise 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 veterinary medicines production enterprise 59.1 2. Two days (one inspector) 1 medicines or 570,00 0,00 570,00 veterinary medicines production enterprise 59.1 3. Three days (one inspector) 1 medicines or 690,00 0,00 690,00 veterinary medicines production enterprise 59.1 4. Four days (one inspector) 1 medicines or 780,00 0,00 780,00 veterinary medicines production enterprise 59.1 5. Five days (one inspector) 1 medicines or 910,00 0,00 910,00 veterinary medicines production enterprise 60. Appraisal of the background and professional 1 medicines producing 70.00 0.00 70.00 experience of the qualified persons of a person medicines manufacturer or importer in terms of conformity to the normative acts requirements to medicines manufacture* 61. Appraisal of the documents related to the 1 medicines production 150.00 0.00 150.00 good manufacturing practice of a medicines enterprise production enterprise, which is not located in an EU member-state – appraisal of the submitted description of the production facilities and procedures* 62. Selection of samples of medicines for 1 sample of medicine 3.00 0.00 3.00 testing* 63. Expertise of an application and Expertise 211.87 0.00 211.87 documentation for distribution of parallel imports of veterinary medicines in Latvia, and making relevant amendments* 63.1. Changes in user instructions of a veterinary Expertise 50.00 0.00 50.00 medicine 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 Expertise 50.00 0.00 50.00 entrepreneur’s registered office address) 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 Expertise 0.50 0.00 0.50 medicine 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 Expertise 4.75 0.00 4.75 medicine 77. Expertise of an application and documentation Expertise 10.00 0.00 10.00 for distribution of the remaining stocks of veterinary medicines if the said medicines were not re-registered or their re-registration was declined* 78. Expertise of an application and documentation Expertise 500.00 0.00 500.00 for distribution of non-registered medicines* 79. Expertise of an application and documentation Expertise 300.00 0.00 300.00 for distribution of non-registered veterinary medicines * 80. Special expertise of an application and Expertise 50.00 0.00 50.00 documentation for work with precursors* 81. Issue of precursors operator cards* Expertise 50.00 0.00 50.00 82. Expertise of an application and documentation 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 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 61.71 0.00 61.71 medicinal products 83.2. One day (one inspector) 1 wholesaler of 123.41 0.00 123.41 medicinal products 83.3. Two days (one inspector) 1 wholesaler of 156.32 0.00 156.32 medicinal products 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 veterinary medicines 84.2. One day (one inspector) 1 wholesaler of 123.41 0.00 123.41 veterinary medicines 84.3. Two days (one inspector) 1 wholesaler of 156.32 0.00 156.32 veterinary medicines 85. Copying of documents 1 page 0.13 0.03 0.16 86. Official publication of Latvian Register of 1 book 3.70 0.78 4.48 Medicines 87. Statistical publication on consumption of 1 compact disc 4.00 0.84 4.84 medicines 88. Official publication of Latvian Register of 1 book 2.50 0.53 3.03 Veterinary Medicines 89. Issue of Medicine Registration Certificate* Registration Certificate 50.00 0.00 50.00 90. Issue of Veterinary Medicine Registration Registration Certificate 50.00 0.00 50.00 Certificate* 91. Issue of a duplicate of Medicine Registration Duplicate of 30.00 0.00 30.00 Certificate* Registration Certificate 92. Issue of a duplicate of Veterinary Medicine Duplicate of 30.00 0.00 30.00 Registration Certificate * Registration Certificate 93. Issue of good manufacturing practice Certificate 65.00 0.00 65.00 certificate for medicines * 94. Issue of good manufacturing practice Certificate 65.00 0.00 65.00 certificate for veterinary medicines* 95. Issue of permit to distribute medicines or Permit 5.00 0.00 5.00 veterinary medicines that are imported in parallel* 96. Issue of permit to import samples of Permit 5.00 0.00 5.00 medicines or veterinary medicines* 97. Issue of permit to import or export Permit 15.00 0.00 15.00 psychotropic and narcotic substances and medicines, as well as precursors* 98. Issue of permit to distribute remaining stocks Permit 50.00 0.00 50.00 of medicines or veterinary medicines if the said medicines were not re-registered or their re-registration was declined* 99. Issue of product certificate* Certificate 65.00 0.00 65.00 99.1 Issue of an abbreviated product certificate Certificate 40,00 0,00 40,00 (pharmaceutical product certificate or free trade certificate)* 100. Issue of licence to work with precursors* Licence 50.00 0.00 50.00 101. Decision on approval of advertising of Decision 20.00 0.00 20.00 medicinal products* 102. Decision on approval of advertising of Decision 20.00 0.00 20.00 veterinary medicinal products * 103. Permit to carry out a clinical trial of medicinal Permit 20.00 0.00 20.00 products* 104. Expertise of medical devices/tools and related documentaton 104.1. Expertise of medical devices/tools made in Latvia and the related documentaton 104.1.1. Expertise of medical devices/tools of Class I 1 expertise 90,00 0,00 90,00 and and the related documentaton (except for the provisions of Subparagraph 104.1.2) 104.1.2. Expertise of medical devices/tools of Class I 1 expertise 95,00 0,00 95,00 in sterial packaging and Class I medical devices with a measuring function and the related documentaton 104.1.3. Expertise of medical devices/tools of Class II 1 expertise 100,00 0,00 100,00 A and and the related documentaton 104.1.4. Expertise of medical devices/tools of Class II 1 expertise 110,00 0,00 110,00 B and and the related documentaton 104.1.5. Expertise of medical devices/tools of Class III 1 expertise 120,00 0,00 120,00 and and the related documentaton 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 1 expertise 110,00 0,00 110,00 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 B, and the related documentation 104.1.8. Expertise of self-verifying medical devices 1 expertise 100,00 0,00 100,00 meant for IVD (in vitro diagnostics) and the related documentation 104.1.9. Expertise of other medical devices meant for 1 expertise 90,00 0,00 90,00 IVD (in vitro diagnostics) and the related documentation 104.1.10. Supplementation of expertise data if a new 1 expertise 45,00 0,00 45,00 medical device specimen is produced or the type specimen is changed or the production technology is changed for the already registered medical devices/tools 104.2. Expertise of other medical devices without CE marking and their quality-certifying documentaton* 104.2.1. Expertise of medical devices/tools of Class I 1 expertise 250,00 0,00 250,00 and and their quality-certifying documentaton (except for the provisions of Subparagraph 104.2.2) 104.2.2. Expertise of medical devices/tools of Class I 1 expertise 280,00 0,00 280,00 in sterial packaging and Class I medical devices with a measuring function and their quality-certifying documentaton 104.2.3. Expertise of medical devices/tools of Class II 1 expertise 300,00 0,00 300,00 A and and their quality-certifying documentaton 104.2.4. Expertise of medical devices/tools of Class II 1 expertise 320,00 0,00 320,00 B and and the quality-certifying documentaton 104.2.5. Expertise of medical devices/tools of Class III 1 expertise 350,00 0,00 350,00 and and their quality-certifying documentaton 104.2.6. Expertise of medical devices/tools meant for 1 expertise 350,00 0,00 350,00 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 quality-certifying documentation 104.2.7. Expertise of medical devices/tools meant for 1 expertise 320,00 0,00 320,00 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 B, and quality-certifying documentation 104.2.8. Expertise of self-verifying medical devices 1 expertise 300,00 0,00 300,00 meant for IVD (in vitro diagnostics) and their quality-certifying documentation 104.2.9. Expertise of other medical devices meant for 1 expertise 250,00 0,00 250,00 IVD (in vitro diagnostics) and their quality- 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 1 expertise 50,00 0,00 50,00 Class I and and the related documentaton (except for the provisions of Subparagraph 105.1.2) 105.1.2. One-time expertise of medical devices/tools of 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 105.1.3. One-time expertise of medical devices/tools of 1 expertise 55,00 0,00 55,00 Class II A and and the related documentaton 105.1.4. One-time expertise of medical devices/tools of 1 expertise 60,00 0,00 60,00 Class II B and and the related documentaton 105.1.5. One-time expertise of medical devices/tools of 1 expertise 70,00 0,00 70,00 Class III and and the related documentaton 105.1.6. One-time expertise of medical devices/tools 1 expertise 70,00 0,00 70,00 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 105.1.7. One-time expertise of medical devices/tools 1 expertise 60,00 0,00 60,00 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 B, and the related documentation 105.1.8. One-time expertise of self-verifying medical 1 expertise 55,00 0,00 55,00 devices meant for IVD (in vitro diagnostics) and the related documentation 105.1.9. One-time expertise of other medical devices 1 expertise 50,00 0,00 50,00 meant for IVD (in vitro diagnostics) and the related documentation 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) 105.2.1. One-time expertise of medical devices/tools of 1 expertise 120,00 0,00 120,00 Class I and and their quality-certifying documentaton (except for the provisions of Subparagraph 105.2.2) 105.2.2. One-time expertise of medical devices/tools of 1 expertise 140,00 0,00 140,00 Class I in sterial packaging and Class I medical devices with a measuring function and their quality-certifying documentaton 105.2.3. One-time expertise of medical devices/tools of 1 expertise 150,00 0,00 150,00 Class II A and and their quality-certifying documentaton 105.2.4. One-time expertise of medical devices/tools of 1 expertise 170,00 0,00 170,00 Class II B and and the quality-certifying documentaton 105.2.5. One-time expertise of medical devices/tools of 1 expertise 180,00 0,00 180,00 Class III and and their quality-certifying documentaton 105.2.6. One-time expertise of medical devices/tools 1 expertise 180,00 0,00 180,00 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 their quality-certifying documentation 105.2.7. One-time expertise of medical devices/tools 1 expertise 170,00 0,00 170,00 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 B, and their quality-certifying documentation 105.2.8. One-time expertise of self-verifying medical 1 expertise 150,00 0,00 150,00 devices meant for IVD (in vitro diagnostics) and their quality-certifying documentation 105.2.9. One-time expertise of other medical devices 1 expertise 120,00 0,00 120,00 meant for IVD (in vitro diagnostics) and their quality-certifying documentation 106. Preparation of documentation* 106.1. Issue of confirmation of a medical device Confirmation 20,00 0,00 20,00 registration certificate of registration certificate 106.2. Issue of confirmation of a medical device Duplicate of 10,00 0,00 10,00 registration certificate registration certificate 106.3. Issue of a medical device registration registration 50,00 0,00 50,00 certificate certificate 106.4. Issue of a permit for release of specially permit 20,00 0,00 20,00 delivered medical devices 106.5. Issue of a dublicate of permit for release of Duplicate of 10,00 0,00 10,00 specially delivered medical devices permit 107. Annual fee for the use of the Register of 1 annual 50,00 0,00 50,00 Medical Devices of the 1st and 2nd security subscription groups of the Latvian Database of Medical Devices* 108. Conformity appraisal of procurement of blood, tissues, cells and organs* 108.1. Conformity appraisal of a blood room, blood 1 institution 450,00 0,00 450,00 preparation department and centre 108.1.1. Appraisal of documentation on changes in the 1 expertise 50,00 0,00 50,00 operations of a blood room, blood preparation department and centre 108.2. Conformity appraisal of a Tissues, Cells and 1 institution 450,00 0,00 450,00 Organs Procurement and Storage Centre 108.2.1. Appraisal of documentation on changes in the 1 expertise 50,00 0,00 50,00 opeartions and standard procedures of a Tissues, Cells and Organs Procurement and Storage Centre

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.