Registration of prices for medicines and medical devices

Online

Individuals

 On the portal you can get the service in several ways:

Using EDS:

1.Log in to the portal or register

2. Click on "Request online" button

3. Fill all sections of e-request

4. Sign a request with digital signature 

5. In personal account ("History of obtained services") familiarize with notification on your request processing status, which will be sent within the stated period.

Online

Legal entities

 On the portal you can get the service in several ways:

Using EDS:

1.Log in to the portal or register

2. Click on "Request online" button

3. Fill all sections of e-request

4. Sign a request with digital signature 

5. In personal account ("History of obtained services") familiarize with notification on your request processing status, which will be sent within the stated period.

Service provider

Individuals

Documents required for submission to the service provider:

1. Application for registration and (or) re-registration of the price of a trade name of a medicinal product for a GOBMP and (or) in the MSHI system, with an appendix:

For domestic manufacturers:

1. A document confirming the applicant's right to register the price or re-register the registered price within the framework of the GOBMP and (or) in the MSHI system (power of attorney, contract, letter of authorization).
2. Information on expenses for registration of the price or re-registration of the registered price within the framework of the GOBMP and (or) in the MSHI system on the letterhead of the applicant, certified by the signature of an authorized person, in the form according to Appendix 7: data of the actual costs incurred for quality assessment.
3. For medicines, the validity period of the registration certificate of which has expired at the time of filing the application, produced on the territory of the Republic of Kazakhstan before the expiration of the registration certificate of the medicinal product, documents confirming the production of medicinal products are provided for registration of the price or re-registration of the registered price within the framework of the GOBMP and (or) in the MSHI system.
4. For medicines submitted for state registration, documents confirming the submission for state registration are provided – an application for state registration of medicines.​

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 GOBMP and (or) in the MSHI system (power of attorney, contract, letter of authorization), including the right to provide information on Ex-Factory prices in the reference countries and prices of actual supplies.
2. Copies of documents confirming the price of medicines (copies of invoices (waybill), invoices) for the last 12 months (if there are actual deliveries), indicating the actual delivery price, except in cases of importation on the grounds provided for in subparagraph 4) of Article 252 of the Code of the Republic of Kazakhstan "On the health of the people and the healthcare system".

If there are no actual deliveries for the last 12 months, copies of documents for the previous period of 12 months are provided:

1. A copy of the customs declaration.
2. A copy of the contract or agreement on the purchase of medicines with information on the price of medicines in force at the time of filing an application for registration or re-registration of the registered price of medicines;
   Information on the actual costs incurred within the framework of the GOBMP and (or) the MSHI system on the applicant's letterhead, certified by the signature of an authorized person, in the form according to Appendix 7: transport costs from the manufacturer to the border of the Republic of Kazakhstan, customs payments; quality assessment costs.

- 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 the medicinal product, for registration of the price or re-registration of the registered price within the framework of the GOBMP and (or) in the MSHI system, documents confirming import are provided: a copy of the conclusion on the quality of goods, as well as a copy of the customs declarations;
- 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 medicines submitted for state registration, documents confirming the submission for state registration are provided – an application for state registration of medicines.

For customers of contract production of original patented medicines:

1. A document confirming the applicant's right to register the price or re-register the registered price within the framework of the GOBMP and (or) in the MSHI system (power of attorney, contract, letter of authorization).
2. Information on expenses for registration of the price or re-registration of the registered price within the framework of the GOBMP and (or) in the MSHI system on the letterhead of the applicant, certified by the signature of an authorized person, in the form according to Appendix 7: data on the actual costs incurred for quality assessment.

- for medicines, the validity period of the registration certificate of which has expired at the time of filing the application, produced on the territory of the Republic of Kazakhstan before the expiration of the registration certificate of the medicinal product, documents confirming the production of medicinal products are provided for registration of the price or re-registration of the registered price within the framework of the GOBMP and (or) in the MSHI system;
- for medicines submitted for state registration, documents confirming the submission for state registration are provided – an application for state registration of medicines;
- a copy of the long-term supply agreement with the customer for the contract production of original patented medicines with information on the price of the manufacturer of the drug, valid at the time of filing an application for registration or re-registration of the registered price of the drug.

Service provider

Legal entities

Documents required for submission to the service provider:

1. Application for registration and (or) re-registration of the price of a trade name of a medicinal product for a GOBMP and (or) in the MSHI system, with an appendix:

For domestic manufacturers:

1. A document confirming the applicant's right to register the price or re-register the registered price within the framework of the GOBMP and (or) in the MSHI system (power of attorney, contract, letter of authorization).
2. Information on expenses for registration of the price or re-registration of the registered price within the framework of the GOBMP and (or) in the MSHI system on the letterhead of the applicant, certified by the signature of an authorized person, in the form according to Appendix 7: data of the actual costs incurred for quality assessment.
3. For medicines, the validity period of the registration certificate of which has expired at the time of filing the application, produced on the territory of the Republic of Kazakhstan before the expiration of the registration certificate of the medicinal product, documents confirming the production of medicinal products are provided for registration of the price or re-registration of the registered price within the framework of the GOBMP and (or) in the MSHI system.
4. For medicines submitted for state registration, documents confirming the submission for state registration are provided – an application for state registration of medicines.​

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 GOBMP and (or) in the MSHI system (power of attorney, contract, letter of authorization), including the right to provide information on Ex-Factory prices in the reference countries and prices of actual supplies.
2. Copies of documents confirming the price of medicines (copies of invoices (waybill), invoices) for the last 12 months (if there are actual deliveries), indicating the actual delivery price, except in cases of importation on the grounds provided for in subparagraph 4) of Article 252 of the Code of the Republic of Kazakhstan "On the health of the people and the healthcare system".

If there are no actual deliveries for the last 12 months, copies of documents for the previous period of 12 months are provided:

1. A copy of the customs declaration.
2. A copy of the contract or agreement on the purchase of medicines with information on the price of medicines in force at the time of filing an application for registration or re-registration of the registered price of medicines;
   Information on the actual costs incurred within the framework of the GOBMP and (or) the MSHI system on the applicant's letterhead, certified by the signature of an authorized person, in the form according to Appendix 7: transport costs from the manufacturer to the border of the Republic of Kazakhstan, customs payments; quality assessment costs.

- 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 the medicinal product, for registration of the price or re-registration of the registered price within the framework of the GOBMP and (or) in the MSHI system, documents confirming import are provided: a copy of the conclusion on the quality of goods, as well as a copy of the customs declarations;
- 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 medicines submitted for state registration, documents confirming the submission for state registration are provided – an application for state registration of medicines.

For customers of contract production of original patented medicines:

1. A document confirming the applicant's right to register the price or re-register the registered price within the framework of the GOBMP and (or) in the MSHI system (power of attorney, contract, letter of authorization).
2. Information on expenses for registration of the price or re-registration of the registered price within the framework of the GOBMP and (or) in the MSHI system on the letterhead of the applicant, certified by the signature of an authorized person, in the form according to Appendix 7: data on the actual costs incurred for quality assessment.

- for medicines, the validity period of the registration certificate of which has expired at the time of filing the application, produced on the territory of the Republic of Kazakhstan before the expiration of the registration certificate of the medicinal product, documents confirming the production of medicinal products are provided for registration of the price or re-registration of the registered price within the framework of the GOBMP and (or) in the MSHI system;
- for medicines submitted for state registration, documents confirming the submission for state registration are provided – an application for state registration of medicines;
- a copy of the long-term supply agreement with the customer for the contract production of original patented medicines with information on the price of the manufacturer of the drug, valid at the time of filing an application for registration or re-registration of the registered price of the drug.

Grounds for refusal to provide the public service established by the laws of the Republic of Kazakhstan

1) the establishment of the inaccuracy of documents submitted by the service recipient to receive the public service, and (or) data (information) contained therein;

2) the non-compliance of service recipient and (or) submitted materials, objects, data and information necessary for the public service provision with the requirements established by these Rules;

3) the absence of consent of the service recipient provided in accordance with Article 8 of the Law of the Republic of Kazakhstan "On Personal Data and Their Protection" to access sensitive personal data required for the public service provision.

Grounds for institution of an administrative procedure

• appeal;
• initiative of an administrative body or official.

 General requirements for the appeal

The appeal submitted in hard copy or electronic form shall indicate:

• Full name, IIN, postal address of a natural person, BIN of a legal entity;
• name of administrative body, official to whom the appeal is submitted;
• the essence of an appeal;
• date of filing an appeal;
• signature of the applicant or his representative;
• other information provided for by legislation of the Republic of Kazakhstan.

If the administrative procedure is on a paid basis, the applicant must submit a document confirming the payment.

 

 

Source: Administrative Procedural Code of Republic of Kazakhstan,
The Law of the RK "On Public services"