Conclusion on safety, quality and efficacy of medicines and medical devices

You can obtain a service via the Portal:

1. Click the "Request online" button on this page, after that the portal of "electronic licensing" will be opened in a new window.
2. In the service info sheet read the package of documents and click the "Order online service" button on the website of the National center for the examination of medicines and medical devices.

You can obtain a service via the Portal:

1. Click the "Request online" button on this page, after that the portal of "electronic licensing" will be opened in a new window.
2. In the service info sheet read the package of documents and click the "Order online service" button on the website of the National center for the examination of medicines and medical devices.

Documents required for submission to service provider:

1. An application for the examination of a medicinal product in accordance with Annex 1 To the rules for the examination of medicinal products, an application for the examination of a medical device on an electronic carrier in accordance with Annex 1 to the Rules for the examination of medical devices.
2. Registration dossier containing the information and documents on the form according to Appendix 2 to Rules of conducting expert examination of medicines for producers of the Republic of Kazakhstan or in the format of Common technical document in the form of Annex 3 to the Rules of examination of medicinal products, the registration dossier of medical products on electronic media, containing materials and documents under the form according to Appendix 2 to the Rules of examination of medical products.
3. Samples of medicines, medical devices (except for medical devices that are devices, devices, equipment), standard samples of chemicals, standard samples of biological preparations, test strains of microorganisms, cell cultures, specific reagents, consumables necessary for reproducibility of laboratory testing methods in quantities sufficient for three-time laboratory tests with a residual shelf life of at least 9 months (except in cases that do not require laboratory testing).
4. Copy of the document confirming payment by the service recipient of the amount for the examination.

Documents required for submission to service provider:

1. An application for the examination of a medicinal product in accordance with Annex 1 To the rules for the examination of medicinal products, an application for the examination of a medical device on an electronic carrier in accordance with Annex 1 to the Rules for the examination of medical devices.
2. Registration dossier containing the information and documents on the form according to Appendix 2 to Rules of conducting expert examination of medicines for producers of the Republic of Kazakhstan or in the format of Common technical document in the form of Annex 3 to the Rules of examination of medicinal products, the registration dossier of medical products on electronic media, containing materials and documents under the form according to Appendix 2 to the Rules of examination of medical products.
3. Samples of medicines, medical devices (except for medical devices that are devices, devices, equipment), standard samples of chemicals, standard samples of biological preparations, test strains of microorganisms, cell cultures, specific reagents, consumables necessary for reproducibility of laboratory testing methods in quantities sufficient for three-time laboratory tests with a residual shelf life of at least 9 months (except in cases that do not require laboratory testing).
4. Copy of the document confirming payment by the service recipient of the amount for the examination.

1) Establishing the unreliability of the documents submitted by the service recipient for the public service receipt and (or) data (information) contained therein.

2) The non-compliance of the service recipient and (or) submitted materials, objects, data and information necessary for the public services provision with requirements of the Rules for expertise of drugs and medical supplies.

3) In relation to the service recipient, there is a court decision (verdict) that has entered into legal force on the prohibition of activities or certain types of activities requiring the receipt of a certain public service.

4) With regard to the service recipient, there is a court decision that has entered into force, on the basis of which the service recipient is deprived of a special right related to the receipt of a public service.

• 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"