Registration of prices for pharmaceuticals and medical devices

1. Application, along with the following documents:

For domestic manufacturers:

1. A document confirming the applicant's right to register the price or re-register the registered price under the statutory free medical assistance and/or in the CSHI system.
2. For pharmaceuticals, the validity period of registration certificate of which has expired at the time of submitting the application and which were produced in the territory of the Republic of Kazakhstan before the expiration of the registration certificate: documents confirming the production of the pharmaceutical are provided for the registration of the price or re-registration of the registered price under the statutory free medical assistance and (or) in the CSHI system.
3. For pharmaceuticals submitted for state registration, documents confirming the submission for state registration are provided: an application for state registration of pharmaceuticals.

For foreign manufacturers:

1. A document confirming the applicant's right to register the price or re-register the registered price under the statutory free medical assistance and/or in the CSHI system, including the right to provide information on prices in the reference countries and prices of actual supplies.
2. Copies of documents confirming the price of pharmaceuticals (copies of invoices, bills) for the last 12 months (if actual deliveries are available), indicating the actual delivery price, except in cases of import on the grounds provided for in subparagraph 4) of Article 252 of the Code of the Republic of Kazakhstan "On Public Health and the Healthcare System". If there are no actual deliveries for the past 12 months, copies of documents for the past 12 months must be provided.
3. A copy of the customs declaration.
4. A copy of the contract or agreement for the purchase of a pharmaceutical with information on the price of the pharmaceutical, valid at the time of submission of the application for registration or re-registration of the registered price of the pharmaceutical.
5. For pharmaceuticals, the registration certificate of which has expired at the time of submitting the application, which have been imported to the territory of the Republic of Kazakhstan prior to the expiry of the registration certificate, for registration of the price or re-registration of the registered price within the framework of the statutory free medical assistance and (or) in the CSHI system, documents confirming the import are submitted: a copy of the conclusion on the quality of the goods, as well as a copy of the customs declarations.
6. For pharmaceuticals imported into the territory of the Republic of Kazakhstan that do not have a registration certificate, a copy of the permit issued by the authorized body for import of pharmaceuticals into the territory of the Republic of Kazakhstan, obtained via the e-Government portal.
7. For pharmaceuticals submitted for state registration, documents confirming the submission for state registration are provided: an application for state registration of pharmaceuticals.

For contract manufacturers of original patented pharmaceuticals:

1. A document confirming the applicant's right to register the price or re-register the registered price under the statutory free medical assistance and/or in the CSHI system.
2. For pharmaceuticals, the validity period of registration certificate of which has expired at the time of submitting the application and which were produced in the territory of the Republic of Kazakhstan before the expiration of the registration certificate: documents confirming the production of the pharmaceutical are provided for the registration of the price or re-registration of the registered price under the statutory free medical assistance and (or) in the CSHI system.
3. For pharmaceuticals submitted for state registration, documents confirming the submission for state registration are provided: an application for state registration of pharmaceuticals.
4. A copy of the long-term supply agreement with the customer for the contract manufacture of original patented pharmaceuticals with information on the price of the pharmaceutical manufacturer, valid at the time of submission of the application for registration or re-registration of the price of the registered pharmaceutical.

1. Application, along with the following documents:

For domestic manufacturers:

1. A document confirming the applicant's right to register the price or re-register the registered price under the statutory free medical assistance and/or in the CSHI system.
2. Information on the actual delivery price with a link to the SK-Pharmacy LLP procurement portal, with supporting documents (minutes, purchase agreement and (or) delivery agreement) for the last purchase during the 12 months preceding the application date;
3. Information on the actual delivery price with a link to the public procurement portal, with supporting documents (minutes, purchase agreement and/or supply agreement) for the last purchase made during the 12 months preceding the application date;
4. Information on the actual costs incurred for quality assessment under the statutory free medical assistance and/or the CSHI system on the applicant's letterhead, certified by the signature of an authorized person, in accordance with Appendix 4.
5. Information with supporting documents (contract, invoice) on the prices of medical devices sold in other countries for the 12 months preceding the date of submission of the application for registration or re-registration of the medical device. If there is no implementation in other countries, the applicant confirms the absence of implementation on the applicant's letterhead, certified by the signature of an authorized person of the applicant.

For foreign manufacturers:

1. An apostilled power of attorney from the manufacturer confirming the applicant's right to register the price or re-register the registered price under the statutory free medical assistance and/or in the CSHI system, indicating the validity period of the document (notarized copy).
2. A copy of the documents confirming the medical device price (copies of invoices (waybills), invoices for the last 12 months (if actual deliveries are available), indicating the actual delivery price, except in cases of import on the grounds provided for in subparagraph 4) of Article 252 of the Code.
3. A copy of the customs declaration for the document referred to in subparagraph 2) of paragraph 14 (for foreign manufacturers).

Copies of documents for the previous 12 months are provided if there are no actual deliveries for the previous 12 months.

In the absence of actual shipments for the specified period, the applicant confirms the absence of import on the applicant's letterhead, signed by an authorized person of the applicant.

The state expert organization also uses copies of invoices (waybills) provided for quality assessment during the analysis;

4. A copy of the contract or purchase agreement for the medical device from the manufacturer's factory (notarized copy).
5. Information on the actual delivery price with a link to the SK-Pharmacy LLP procurement portal, with supporting documents (minutes, purchase agreement and (or) delivery agreement) for the last purchase during the 12 months preceding the application date.
6. Information on the actual delivery price with a link to the public procurement portal, with supporting documents (minutes, purchase agreement and/or supply agreement) for the last purchase made during the 12 months preceding the application date.