The state registration of medicines is a prerequisite for the introduction of new medicines in the pharmaceutical market of the Republic of Kazakhstan.
The state registration and re-registration covers medicines produced in the Republic of Kazakhstan, as well as those registered in the country of origin imported into its territory, including:
- medicine bearing trade names specifying a dosage form, dosage, filling;
- bulk pharmaceuticals imported into the Republic of Kazakhstan;
- new combinations of medicines previously registered in the Republic of Kazakhstan specifying a dosage form, dosage, filling;
- medicines previously registered in the Republic of Kazakhstan but produced by other organizations in other dosage forms with a different dosage, filling, new packaging, a different composition of excipients and a under different name.
The following products are not subject to the state registration:
- medicines prepared in pharmacies;
- drug substances produced in accordance with Good Manufacturing Practices.
The state registration, re-registration and variation of registration dossiers is performed by a state authority in the area of drugs, medical devices and medical equipment circulation (hereinafter the Committee or the State agency).
The expert examination of medicines is performed by a state expert organization in the area of circulation of pharmaceuticals, medical devices and medical equipment, which is not directly involved in the design and manufacture of the medicine in question (hereinafter NCEM or the Expert Organization) under a contract with the applicant.
In the course of the state registration, re-registration and variation of the registration dossier in accordance with order № 735 of the Ministry of Health and Social Development of the Republic of Kazakhstan dated November 18, 2009 “On Approval of Rules for the State Registration, Re-registration and Variation of Registration Dossiers of Medicines, Medical Devices and Medical Equipment" the expertise of medicines involves the following steps:
- Initial expertise;
- Analytical expertise;
- Specialized pharmaceutical expertise;
- Specialized pharmacological expertise;
- Safety, efficacy and quality-related conclusions
Each subsequent stage of the expertise of a medicine is carried out on the basis of the positive conclusion of the previous stage.
Below is the list of documents required in the course of the expertise of medicines:
- The list of documents of the registration dossier provided in the course of the expertise of medicines in the Republic of Kazakhstan in the format of the Common Technical Document (for medicines manufactured under the Good Manufacturing Practice);
- The documents of the registration dossier provided in the course of the expertise of medicines manufactured under rules other than the Good Manufacturing Practice;
- A list of documents required for dossier variation;