List of documents for registration/re-registration of prices for medicines for wholesale and retail sales
16.06.2021For registration or re-registration of prices for medicines, you must provide a list of documents in accordance with the order of the Minister of Health of the Republic of Kazakhstan dated December 11, 2020 No. KR DSM-247/2020
List of documents for registration/re-registration of prices for medicines for wholesale and retail sales
For domestic manufacturers:
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For foreign manufacturers:
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1) a document confirming the applicant's right to register the price or re-register the registered price for wholesale retail sales (power of attorney, contract, authorization letter, etc.); 2) the manufacturer's ceiling price for the wholesale and retail sale of the medicines on the applicant's letterhead, certified by the signature of the authorized person; 3) information on expenses for wholesale and retail sales on the applicant's letterhead, certified by the signature of the authorized person, in the form according to appendix 2 and includes: data on the actual costs incurred for quality assessment; data of marketing expenses. For medicines that were not sold on the territory of the Republic of Kazakhstan before the price was registered, data on projected costs are provided; 4) a copy of the document confirming the effective patent protection of the original medicinal product or biological original medicinal product under the INN, indicating the expiration date of the patent protection, or a letter from the manufacturer or the holder of the registration certificate confirming the originality of the drug under the INN (if available);
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1) a document confirming the applicant's right to register the price or re-register the registered price (power of attorney, contract, letter of authorization, etc.), including the right to provide information on EXW prices in the reference countries and on the prices of actual deliveries; 2) the manufacturer's ceiling price for the wholesale and retail sale of the medicines on the applicant's letterhead, certified by the signature of the authorized person; 3) the table of prices EXW in the reference countries (for imported medicines) on the letterhead of the applicant, certified by the signature of the authorized person. The EXW price table displays information on the quantity of medicines in consumer packaging in each country, recalculated by the quantity registered in the Republic of Kazakhstan in accordance with Appendix 3 to these Rules; If the application does not contain information about the EXW prices for medicines in any reference country or the actual price of supplies to the Republic of Kazakhstan, the applicant indicates in the appropriate column of the EXW price table in accordance with Appendix 3 to these Rules the reason for its absence; 4) information about the EXW price in the country of manufacture (in case of absence of state registration of the medicine in the reference countries) in the form, according to Appendix 3 to these Rules on the letterhead of the applicant, certified by the signature of the authorized person; 5) a copy of the document confirming the price of the medicine (a copy of the invoice (waybill), invoice or customs declaration) for the last 12 months (if there are actual deliveries), except for cases of import on the grounds provided for in subparagraph 4) article 252 The Code of the Republic of Kazakhstan dated July 7, 2020 "On the Public Health and Health Care System"(hereinafter referred to as the Code). If there are no actual deliveries for the last 12 months, copies of documents for the previous period of 12 months are provided if there are any remaining medicines; 6) a copy of the contract or an agreement for the purchase of medicines; 7) information on expenses for wholesale and retail sales of medicines is submitted on the applicant's letterhead certified by the signature of an authorized person, in the form according to Appendix 2 and include: data on actual transport costs incurred from the manufacturer to the border of the Republic of Kazakhstan; customs expenses data; data on quality assessment costs; data of marketing expenses. For medicines that were not sold on the territory of the Republic of Kazakhstan before the price was registered, data on projected costs are provided; 4) a copy of the document confirming the effective patent protection of the original medicinal product or biological original medicinal product under the INN, indicating the expiration date of the patent protection, or a letter from the manufacturer or the holder of the registration certificate confirming the originality of the medicine under the INN (if available);
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5. For medicines, the validity period of the registration certificate of which has expired at the time of filing the application, produced in the territory of the Republic of Kazakhstan before the expiration of the registration certificate of medicinal products, documents confirming the production of medicines are provided. 6. For medicines submitted for registration, documents confirming the submission for registration are provided – an application for registration.
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9. Documents confirming the import of medicines: a copy of the conclusion on the quality of goods, as well as a copy of the customs declaration; 6. For medicines submitted for registration, documents confirming the submission for registration are provided – an application for registration. 11. For medicines, the validity period of the registration certificate of which has expired at the time of filing the application, imported into the territory of the Republic of Kazakhstan before the expiration of the registration certificate of medicines, documents confirming the import of medicinal products are provided: a copy of the conclusion on the quality of goods, as well as a copy of the customs declaration; |
List of documents for registration/re-registration of prices for medicines within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance
For domestic manufacturers:
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For foreign manufacturers: |
1) a document confirming the applicant's right to register the price or re-register the registered price within the framework of the Guaranteed Volume of Free Medical Care and (or) in the Compulsory Social Health Insurance system (power of attorney, contract, authorization letter, etc.); 2) the manufacturer's price within the framework of the Guaranteed Volume of Free Medical Care and (or) in the Compulsory Social Health Insurance system on the applicant's letterhead, certified by the signature of the authorized person; 3) information on expenses for price registration or re-registration of the registered price within the framework of the Guaranteed Volume of Free Medical Care and (or) in the Compulsory Social Health Insurance system on the applicant's letterhead, certified by the signature of the authorized person, in the form according to Appendix 7: data on the actual costs incurred for quality assessment; 4) a copy of the document confirming the effective patent protection of the original medicinal product or biological original medicinal product under the INN, indicating the expiration date of the patent protection, or a letter from the manufacturer or the holder of the registration certificate confirming the originality of the drug under the INN (if available);
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1) a document confirming the applicant's right to register the price or re-register the registered price (power of attorney, contract, letter of authorization, etc.), including the right to provide information on EXW prices in the reference countries and on the prices of actual deliveries; 2) the manufacturer's price within the framework of the Guaranteed Volume of Free Medical Care and (or) in the Compulsory Social Health Insurance system on the applicant's letterhead, certified by the signature of the authorized person; 3) the EXW price table for registering the price or re-registering the registered price in the framework of the Guaranteed Volume of Free Medical Care and (or) in the Compulsory Social Health Insurance system in the reference countries (for imported medicines), in the framework of the Guaranteed Volume of Free Medical Care and the Compulsory Social Health Insurance system on the applicant's letterhead, certified by the signature of an authorized person. The EXW price table for registering the price or re-registering the registered price under the Guaranteed Volume of Free Medical Care and (or) in the Compulsory Social Health Insurance system displays information about the quantity of medicines in consumer packaging in each country, recalculated per unit of measurement of medicines in accordance with Appendix 8 to these Rules. If the application does not contain information about the EXW prices for medicines in any reference country or the actual price of supplies to the Republic of Kazakhstan, the applicant justifies the reason for its absence in the appropriate column of the EXW price table for the registration of the price or re-registration of the registered price in the framework of the Guaranteed Volume of Free Medical Care and (or) the Compulsory Social Health Insurance system in accordance with Appendix 8 to these Rules; 4) information on the EXW price in the country of manufacture (in case of absence of state registration of medicines in the reference countries) in the form according to Appendix 8 to the Rules on the applicant's letterhead, certified by the signature of an authorized person; 5) copies of documents confirming the price of the medicines (copies of invoices( waybill), commercial invoice or customs declaration) for the last 12 months (if there are actual deliveries), indicating the actual delivery price, except for cases of import on the grounds stipulated by subparagraph 4) of Article 252 of the Code. If there are no actual deliveries for the last 12 months, copies of documents for the previous period of 12 months are provided if there are any remaining medicines; 6) a copy of the contract or an agreement for the purchase of medicines; 7) information on expenses for registration of the price or re-registration of the registered price in the framework of the Guaranteed Volume of Free Medical care and (or) in the Compulsory Social Health Insurance system on the applicant's letterhead, certified by the signature of the authorized person, in the form according to Appendix 7: data on actual transport costs incurred from the manufacturer to the border of the Republic of Kazakhstan; customs expenses, data on quality assessment costs; For medicines, the delivery of which to the territory of the Republic of Kazakhstan before the registration of the price in the framework of the Guaranteed Volume of Free Medical Care and (or) in the Compulsory Social Health Insurance system was not carried out, the data of the projected costs are provided; 4) a copy of the document confirming the effective patent protection of the original medicinal product or biological original medicinal product under the INN, indicating the expiration date of the patent protection, or a letter from the manufacturer or the holder of the registration certificate confirming the originality of the medicine under the INN (if available);
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5) for medicines, the validity period of the registration certificate of which has expired at the time of filing the application, produced in the territory of the Republic of Kazakhstan before the expiration of the registration certificate of medicines, for registration of the price or re-registration of the registered price within the framework of the Guaranteed Volume of Free Medical Care and (or) in the Compulsory Social Health Insurance system, documents confirming the production of medicines are provided;
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9) for medicines, the validity of the registration certificate of which has expired at the time of filing the application, imported into the territory of the Republic of Kazakhstan before the expiration of the registration certificate of medicinal products, for registration of the price or re-registration of the registered price under the Guaranteed Volume of Free Medical Care and (or) in the Compulsory Social Health Insurance system, documents confirming the import are provided: a copy of the conclusion on the quality of goods, as well as a copy of the customs declaration; |
6. For medicines submitted for registration, documents confirming the submission for registration are provided – an application for registration.
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10) for medicines imported into the territory of the Republic of Kazakhstan that do not have a registration certificate - a copy of the permission of the authorized body for the import of medicines into the territory of the Republic of Kazakhstan, obtained through the e-government web portal. For orphan drugs, it is allowed to provide documents without a copy of the permission of the authorized body for import;
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6. For medicines submitted for registration, documents confirming the submission for registration are provided – an application for registration.
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