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
# / Description of Service / Unit / Price excl. PVN (LVL) / VAT (LVL) / Price incl. VAT(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 (except Subparagraphs 1.1.2 and 1.1.3) / Application / 10 000.00 / 0.00 / 10 000.00
1.1.2. / Medicines containing a fixed combination of known active substances (new medicines containing at least two active substances, whose combination has never been earlier registered as medicines with a constant formulation), medicines of similar biological origin or those which are widely used for therapeutic purposes / Application / 4 000.00 / 0.00 / 4 000.00
1.1.3. / Basically similar medicines – generic medicines, compound registration application or other application, except such applications as mentioned in Subparagraphs 1.4, 1.5, 1.6 and 1.7 hereof / Application / 3 000.00 / 0.00 / 3 000.00
1.2. / Each additional medicinal form or substitution of an active substance with another salt, ester complex or isomer if their action and safety characteristics do not differ significantly / Application / 2 000.00 / 0.00 / 2 000.00
1.3. / Each additional strength (concentration) or commercial packaging of a medicine, including if substitution of an active substance with another salt, ester complex or isomer if their action and safety characteristics do not differ significantly, for each application regarding medicines with identical registration documentation but different names of medicines and the same or different registration holder (multiple application), if submitted at the same time / Application / 1 000.00 / 0.00 / 1 000.00
1.4. / Traditionally used phytogenic medicinal products (phytogenic medicines eligible for a simplified registration procedure)
1.4.1. / containing three or less active substances / Application / 1 000.00 / 0.00 / 1 000.00
1.4.2. / containing more than three active substances / Application / 1 500.00 / 0.00 / 1 500.00
1.5. / Homeopathic medicines with therapeutic indications / Application / 1 000.00 / 0.00 / 1 000.00
1.6. / Homeopathic medicines without therapeutic indications by a simplified registration procedure / Application / 400.00 / 0.00 / 400.00
1.7. / Anthroposophic medicines, which are described in officially used pharmacopoeia and produced using a homeopathic method / Application / 400.00 / 0.00 / 400.00
2. / Expert’s assessment of an application and the enclosed documentation for re-registration of medicinal product by the national procedure *
2.1. / One officinal form (of the medicine) / Application / 2 000.00 / 0.00 / 2 000.00
2.1.1. / Each extra form of the medicine / Application / 1 000.00 / 0.00 / 1 000.00
2.1.2. / Each additional strength (concentration) or commercial packaging of a medicine, each application regarding medicines with identical registration documentation but different names of medicines and the same or different registration holder (multiple application), if submitted at the same time / Application / 500.00 / 0.00 / 500.00
2.2. / Traditionally used phytogenic medicines / Application / 600.00 / 0.00 / 600.00
2.3. / Homeopathic medicines with therapeutic indications / Application / 500.00 / 0.00 / 500.00
2.4. / Homeopathic medicines without therapeutic indications (registered by a simplified registration procedure) / Application / 200.00 / 0.00 / 200.00
3. / Regularly updated safety report expertise of medicines registered by the national procedure - for one medicine* / Report / 1 000.00 / 0.00 / 1 000.00
4. / Expertise of documentation of changes in such medicinal products as registered by the national procedure*
4.1. / Minor changes of Type I A / One change / 100.00 / 0.00 / 100.00
4.2. / Minor changes of Type I B / One change / 150.00 / 0.00 / 150.00
4.3. / Significant changes of Type II requiring an in-depth evaluation of research documentation / One change / 300.00 / 0.00 / 300.00
4.4. / Significant changes of Type II not requiring an in-depth evaluation of research documentation / One change / 100.00 / 0.00 / 100.00
4.5. / Significant changes of Type II related with the change of a registration certificate holder (where the new registration certificate holder and the existing holder are not one and the same person) / One change / 100.00 / 0.00 / 100.00
4.6. / Changes in user instructions or marking (not related to changes in the medicine description) / One change / 100.00 / 0.00 / 100.00
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 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 / Application / 600.00 / 0.00 / 600.00
5.4. / For procedure (in addition to Subparagraphs 5.1, 5.2 and 5.3)
5.4.1. / Initial procedure of interstate recognition / Procedure number / 5 000.00 / 0.00 / 5 000.00
5.4.2. / Repeated procedure of interstate recognition / Procedure number / 3 000.00 / 0.00 / 3 000.00
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 combination, for similar medicines of biological origin or widely used medicines / Application / 4 000.00 / 0.00 / 4 000.00
6.1.3. / Basically similar medicines – generic medicines, compound registration application or other application / Application / 3 000.00 / 0.00 / 3 000.00
6.2. / Each extra medicinal form / Application / 2 000.00 / 0.00 / 2 000.00
6.3. / Each additional strength (concentration) or 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 / Application / 1 000.00 / 0.00 / 1 000.00
6.4. / For procedure (in addition to Subparagraphs 6.1, 6.2 and 6.3 hereof) / Procedure number / 9 000.00 / 0.00 / 9 000.00
7. / Expertise of an application and the enclosed documentation for medicinal product registration by an interstate recognition procedure, where Latvia is an involved state*
7.1. / Medicinal form submitted for the first time / Application / 2 000,00 / 0,00 / 2 000,00
7.1.1. / Each extra medicinal form / Application / 1 000,00 / 0,00 / 1 000,00
7.1.2. / Each additional strength (concentration) or 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 / Application / 500,00 / 0,00 / 500,00
8. / Expertise of an application and the enclosed documentation for medicinal product registration by a decentralized procedure, where Latvia is an involved state*
8.1. / Medicinal form submitted for the first time / Application / 3 000.00 / 0.00 / 3 000.00
8.1.1. / Each extra medicinal form / Application / 2 000.00 / 0.00 / 2 000.00
8.1.2. / Each additional strength (concentration) or 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 / Application / 1 000.00 / 0.00 / 1 000.00
9. / Expert’s assessment of an application and the enclosed documentation for re-registration of medicinal product by the interstate recognition procedure and the decentralized procedure, where Latvia is
9.1. / a reference state*
9.1.1. / One officinal form (of a medicine) / Application / 2 000.00 / 0.00 / 2 000.00
9.1.2. / Each extra medicinal form / Application / 1 000.00 / 0.00 / 1 000.00
9.1.3. / Each additional strength (concentration) or 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 / Application / 500.00 / 0.00 / 500.00
9.1.4. / For procedure (in addition to Subparagraphs 9.1.1, 9.1.2 and 9.1.3 hereof) / Procedure number / 3 000.00 / 0.00 / 3 000.00
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 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 / Application / 500.00 / 0.00 / 500.00
10. / Regularly updated safety report expertise of medicines registered by an interstate recognition procedure and a decentralized procedure, where Latvia is a reference state*
10.1. / One medicine / Report / 1 000.00 / 0.00 / 1 000.00
10.2. / For procedure (in addition to Subparagraph 10.1 hereof) / Procedure number / 1 000.00 / 0.00 / 1 000.00
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-depth evaluation of research documentation / One change / 300.00 / 0.00 / 300.00
11.4. / Significant changes of Type II not requiring an in-depth evaluation of research documentation / One change / 100.00 / 0.00 / 100.00
11.5. / Significant changes of Type II related with the change of a registration certificate holder / One change / 100.00 / 0.00 / 100.00
11.6. / Changes in user instructions or marking (not related to changes in the medicine description) / One change / 100.00 / 0.00 / 100.00
11.7. / For procedure if Latvia is the responsible (reference) state
11.7.1. / Significant changes of Type II requiring an in-depth scientific evaluation of documentation / One change / 600.00 / 0.00 / 600.00
11.7.2. / Other changes except those mentioned in Subparagraph 11.7.1 hereof / One change / 300.00 / 0.00 / 300.00
12. / Post-registration surveillance of medicines (per annum)*
12.1. / Each registered medicinal form and strength (concentration), except for the products mentioned in Paragraph 13 hereof / Registration number / 350.00 / 0.00 / 350.00
12.2. / Traditionally used phytogenic medicines and medicines used for diagnostic purposes / Registration number / 100.00 / 0.00 / 100.00
12.3. / Homeopathic medicines with therapeutic indications / Registration number / 100.00 / 0.00 / 100.00
12.4. / Homeopathic medicines without therapeutic indications (registered by a simplified registration procedure) and anthroposophic medicines / Registration number / 30.00 / 0.00 / 30.00
13. / Evaluation of a product (e.g. food supplement, cosmetic product, biocide, medical device) with the aim of deciding on its conformance to the definition of a medicinal product or veterinary product*
13.1. / A products, whose documentation evaluation does not require in-depth scientific expertise / Application / 300.00 / 0.00 / 300.00
13.2. / In-depth scientific expertise of product’s formulation and pharmacologic properties / Application / 600.00 / 0.00 / 600.00
14. / Expertise of application and documentation for distribution of medicinal products in Latvia that were imported in parallel and making amendments* / Expertise / 211.87 / 0.00 / 211.87
14.1. / changes in user instructions of a medicine / Expertise / 50.00 / 0.00 / 50.00
14.2. / changes in the marking of a medicine / Expertise / 50.00 / 0.00 / 50.00
14.3. / Changes in a document (change of the registered office of an entrepreneur) / Expertise / 50.00 / 0.00 / 50.00
15. / Expertise of the application and documentation for distribution of unregistered, individually assigned medicinal products (in such cases as provided for The Pharmacy Act, Clause 10, Paragraph 7, Subparagraph "a")*
15.1. / first entry of the medicinal product in a document / Expertise / 0.50 / 0.00 / 0.50
15.2. / each subsequent entry of medicine in a document / Expertise / 0.50 / 0.00 / 0.50
16. / Expertise of the application and documentation for distribution of unregistered, individually assigned medicinal products (in such cases as provided for The Pharmacy Act, Clause 10, Paragraph 7, Subparagraph "b" and "c")*
16.1. / first entry of the medicinal product in a document / Expertise / 15.00 / 0.00 / 15.00
16.2. / each subsequent entry of medicine in a document / Expertise / 4.75 / 0.00 / 4.75
17. / Expertise of the application and documentation for importing of samples of medicinal products*
17.1. / up to five entries of medicine / Expertise / 5.00 / 0.00 / 5.00
17.2. / each subsequent entry of medicine / Expertise / 1.00 / 0.00 / 1.00
18. / Expertise of the application and the enclosed documentation of a pharmaceutical or veterinary pharmaceutical enterprise in the following cases*
18.1. / Change of the legal status or type of an entrepreneur or transfer of title for any constant parts (shares) of the entrepreneur’s business / Expertise of documentation of 1 pharmaceutical or veterinary pharmaceutical enterprise / 50.00 / 0.00 / 50.00
18.2. / Replacement of a pharmacy manager, responsible officials of a wholesaler of medicinal or veterinary products, or change of qualified persons of a manufacturer or importer of medicines or veterinary medicines, officials responsible for production of active pharmaceutical substances or controllable substances, heads of quality control structural units or production structural units, officials responsible for observance of special requirements to medicinal or veterinary product manufacturer or importer (as well as change of surnames) / Expertise of documentation regarding 1 official / 50.00 / 0.00 / 50.00
18.3. / Change of the name of an entrepreneur’s firm or a pharmaceutical or veterinary pharmaceutical enterprise (if different from the firm’s name) / Expertise of documentation of 1 pharmaceutical or veterinary pharmaceutical enterprise / 50.00 / 0.00 / 50.00
18.4. / Change of the registered office (legal address) of an entrepreneur / Expertise of documentation of 1 pharmaceutical or veterinary pharmaceutical enterprise / 50.00 / 0.00 / 50.00
18.5. / Change of the surname of an individual entrepreneur / Expertise of documentation regarding 1 official / 50.00 / 0.00 / 50.00
18.6. / In view of closing of a pharmacy affiliate or branch of a wholesaler of medicines or veterinary medicines / Expertise of documentation of 1 pharmaceutical or veterinary pharmaceutical enterprise / 30.00 / 0.00 / 30.00
18.7. / In view of suspension of a special permit (licence) to perform pharmaceutical or veterinary pharmaceutical activities / Expertise of documentation of 1 pharmaceutical or veterinary pharmaceutical enterprise / 30.00 / 0.00 / 30.00
18.8. / In view of suspension of operations of a pharmacy affiliate or a branch of wholesaler of medicines or veterinary medicines / Expertise of documentation of 1 pharmaceutical or veterinary pharmaceutical enterprise / 30.00 / 0.00 / 30.00
18.9. / In view of any amendments in the annex to a special permit (licence) for pharmaceutical or veterinary pharmaceutical activity if no expert’s assessment ofpharmaceutical or veterinary pharmaceutical activities is required / Expertise of documentation of 1 pharmaceutical or veterinary pharmaceutical enterprise / 30.00 / 0.00 / 30.00
18.10. / Amendments to documents and information if no re-registration of a special permit (licence) for pharmaceutical or veterinary pharmaceutical activity is required / Expertise of documentation of 1 pharmaceutical or veterinary pharmaceutical enterprise / 30.00 / 0.00 / 30.00
18.11. / Renewal of a special permit (licence) for pharmaceutical or veterinary pharmaceutical operations if no conformity evaluation of the pharmaceutical or veterinary pharmaceutical enterprise is required / 1 expertise / 50.00 / 0.00 / 50.00
18.12. / Renewal of a special permit (licence) for pharmaceutical or veterinary pharmaceutical operations, or renewal of any special activity conditions as provided for in the special permit (licence) for pharmaceutical or veterinary pharmaceutical operations, or resumption of production or importing of any concrete medicine or veterinary medicine, if no conformity evaluation of the pharmaceutical or veterinary pharmaceutical enterprise is required / Expertise of documentation of 1 pharmaceutical or veterinary pharmaceutical enterprise / 30.00 / 0.00 / 30.00
18.13. / Expertise of the documents of a pharmaceutical or veterinary pharmaceutical enterprise if it commences (carries out) production or importing of raw materials / Expertise of documentation of 1 pharmaceutical or veterinary pharmaceutical enterprise / 30.00 / 0.00 / 30.00
19. / Evaluation of documentation for commencement of pharmacy’s operations, commencement of pharmaceutical operations at a new location (in new premises), commencement of observance of a new special operation prerequisite and operation procedure documentation (certifications)*
19.1. / Drugstores (pharmacies) of general type
19.1.1. / If a pharmacy is located within an urban territory (in a city) / Expertise of documentation of 1 pharmacy / 100.00 / 0.00 / 100.00
19.1.2. / If a pharmacy is located in a city (town) and has one affiliate / Expertise of documentation of 1 pharmacy and its affiliate / 80.00 / 0.00 / 80.00
19.1.3. / If a pharmacy is located in a city (town) and has two affiliates / Expertise of documentation of 1 pharmacy and 2 affiliates / 70.00 / 0.00 / 70.00
19.1.4. / If a pharmacy is located in the country (rural territory) / Expertise of documentation of 1 pharmacy / 50.00 / 0.00 / 50.00
19.1.5. / If a pharmacy is located in the country and has one affiliate / Expertise of documentation of 1 pharmacy / 40.00 / 0.00 / 40.00
19.1.6. / If a pharmacy is located in the country and has two affiliates / Expertise of documentation of 1 pharmacy / 35.00 / 0.00 / 35.00
19.2. / Pharmacy of closed type / Expertise of documentation of 1 pharmacy and its affiliates / 45.00 / 0.00 / 45.00
19.3. / One pharmacy affiliate if no conformity evaluation of the pharmacy is required / Expertise of documentation of 1 affiliate / 35.00 / 0.00 / 35.00
21. / Appraisal of conformity of a pharmaceutical company (wholesaler or manufacture of medicinal products)*
21.1. / Manufacturer or importer of medicinal products / Expertise of the documentation of 1 manufacturer or importer of medicinal products / 400,00 / 0,00 / 400,00
21.2. / Manufacturer of medicinal products / Expertise of the documentation of 1 manufacturer of medicinal products / 300,00 / 0,00 / 300,00
21.3. / Manufacturer of medicinal products (partial production process) / Expertise of the documentation of 1 manufacturer of medicinal products / 300,00 / 0,00 / 300,00
21.4. / Company only producing medicinal products for trial / Expertise of the documentation of 1 manufacturer of medicinal products / 200,00 / 0,00 / 200,00
21.5. / Wholesaler of medicinal products / Expertise of the documentation of 1 wholesaler / 300,00 / 0,00 / 300,00
21.6. / Department of a wholesaler of medicinal products / Expertise of the documentation of 1 wholesaler department / 70,00 / 0,00 / 70,00
21.7. / Manufacturer of active substances or controllable medicines / Expertise of the documentation of 1 manufacturer / 300,00 / 0,00 / 300,00
21.8. / Company engaged in ethyl alcohol filling (packing) only / Expertise of the documentation of 1 manufacturer or wholesaler of medicinal products / 200,00 / 0,00 / 200,00"
23. / Preparation & printing of ordered materials / 1 page / 0,85 / 0,18 / 1,03
35. / Reviewing of an application for a clinical reserach of medicinal products and the enclosed documentation* / 1 expertise / 1 000,00 / 0,00 / 1 000,00
35.1 / Appraisal of conformity to the good clinical practice for a clinical research centre or a clinical research-related institutionin a country belonging to the European Economic Area in connection with medicinal product certificate submission for re-registration of the medicinal product*
35.1 1. / One day (one inspector) / 1 clinical research centre/ related institutiton / 246,00 / 0,00 / 246,00
35.1 2. / Two days (one inspector) / 1 clinical research centre/ related institutiton / 312,00 / 0,00 / 312,00
35.1 3. / Three days (one inspector) / 1 clinical research centre/ related institutiton / 378,00 / 0,00 / 378,00
35.1 4. / Four days (one inspector) / 1 clinical research centre/ related institutiton / 444,00 / 0,00 / 444,00
35.1 5. / Five days (one inspector) / 1 clinical research centre/ related institutiton / 510,00 / 0,00 / 510,00
35.2 / Appraisal of conformity to the good clinical practice for a clinical research centre or a clinical research-related institution in a country, which does not belong to the European Economic Area, in connection with medicinal product certificate submission for re-registration of the medicinal product*
35.2 1. / One day (one inspector) / 1 clinical research centre/ related institutiton / 450,00 / 0,00 / 450,00
35.2 2. / Two days (one inspector) / 1 clinical research centre/ related institutiton / 570,00 / 0,00 / 570,00
35.2 3. / Three days (one inspector) / 1 clinical research centre/ related institutiton / 690,00 / 0,00 / 690,00
35.2 4. / Four days (one inspector) / 1 clinical research centre/ related institutiton / 780,00 / 0,00 / 780,00
35.2 5. / Five days (one inspector) / 1 clinical research centre/ related institutiton / 910,00 / 0,00 / 910,00
36. / Reviewing of amendments to the protocol of clinical trial of a medicinal product* / 1 amendment / 150.00 / 0.00 / 150.00
37. / Reviewing of an application and the enclosed documents regarding surveillance of the use of a medicinal product submitted on the initiative of the manufacturer of the medicinal product (its representative)* / 1 expertise / 200.00 / 0.00 / 200.00
38. / Expertise of an application and the enclosed documentation for import/export of psychotropic and narcotic substances, as well as precursors* / Expertise / 15.00 / 0.00 / 15.00
39. / Annual fee for receipt of information from the database of the Latvian Register of Medicines / Subscription for 1 year / 182.60 / 38.35 / 220.95
40. / Medicinal product quality control*
40.1. / Identification of a medicinal product
40.1.1. / using a chemical reaction / 1 test / 10.40 / 0.00 / 10.40
40.1.2. / using instrumental methods and thin-layer chromatography (TLC) / 1 test / 26.65 / 0.00 / 26.65
40.2. / transparency determination / 1 test / 4.42 / 0.00 / 4.42
40.3. / colour conformity determination / 1 test / 4.42 / 0.00 / 4.42
40.4. / solubility determination / 1 test / 4.42 / 0.00 / 4.42
40.5. / pH determination / 1 test / 8.97 / 0.00 / 8.97
40.6. / density determination / 1 test / 9.88 / 0.00 / 9.88
40.7. / refraction coefficient identification / 1 test / 4.42 / 0.00 / 4.42
40.8. / melting point identification / 1 test / 10.92 / 0.00 / 10.92
40.9. / optical rotation determination / 1 test / 12.09 / 0.00 / 12.09
40.10. / Identification of mechanical admixtures
40.10.1. / visually / 1 test / 7.93 / 0.00 / 7.93
40.10.2. / instrumentally / 1 test / 12.09 / 0.00 / 12.09
40.11. / Identification of admixtures
40.11.1. / using limiting test methods / 1 test / 8.71 / 0.00 / 8.71
40.11.2. / using thin-layer chromatography (TLC) / 1 test / 34.45 / 0.00 / 34.45
40.12. / Rated capacity identification / 1 test / 1.56 / 0.00 / 1.56
40.13. / Identification of the mean mass and deviations from the mean mass / 1 test / 5.46 / 0.00 / 5.46
40.14. / Sulphate ash content identification / 1 test / 10.27 / 0.00 / 10.27
40.15. / Heavy metal content identification / 1 test / 10.27 / 0.00 / 10.27