Issue of conclusion on safety, quality and efficacy of medicines and medical devices
Legal person
Natural person
It is established in accordance with the price list of the service provider, approved by Order of the Minister of Health of the Republic of Kazakhstan No. 671 of 31.08.2017
The amount of payments should not exceed 10% of the amount required for payment (for amounts up to 1000 tenge, the allowable overpayment is 100 tenge)
According to paragraph 4. of Annex 5 of the Regulation
The application for this service is submitted through the elicense.kz and through integration interaction is sent (for processing) to the information system "National Center for the Examination of Medicines and Medical Devices" (NCEMMD) of the Ministry of Health of the Republic of Kazakhstan. If you have any questions about the provision of the service, please contact the authorized state body.
In addition, we inform that after the service is provided by the state body, the result goes to the personal account on elicense.kz portal.
Issue of conclusion on safety, quality and efficacy of medicines and medical devices
For individuals
- Application in electronic form for the examination of a medicinal product in accordance with Annex 1 To the rules for the examination of medicinal products, for the examination of a medical device in accordance with Annex 1 to the Rules for the examination of medical products (necessarily , job specifications )(Data form)
- An electronic copy of the 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 medicines, an electronic copy of the registration dossier of medical devices according to Appendix 2 to the Rules of examination of medical products (necessarily , job specifications )
- Samples of medicines, medical devices, standard samples, specific reagents, consumables necessary for reproducibility of laboratory testing methods, the applicant provides to the applicant service Center of the service provider in quantities sufficient for three-time tests with a residual shelf life of at least six months (except for cases that do not require laboratory tests) (necessarily , job specifications )
- An electronic copy of the document confirming payment by the service recipient of the amount for the examination (necessarily , job specifications )
- Application for recjgnition of the organization or testing Laboratory in form according to Annex 3 hereto (mandatory) (Form of information) (necessarily )(Data form)
- Application in electronic form for the examination of a medicinal product in accordance with Annex 1 To the rules for the examination of medicinal products, for the examination of a medical device in accordance with Annex 1 to the Rules for the examination of medical products (necessarily , job specifications )(Data form)
- An electronic copy of the 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 medicines, an electronic copy of the registration dossier of medical devices according to Appendix 2 to the Rules of examination of medical products (necessarily , job specifications )
- Samples of medicines, medical devices, standard samples, specific reagents, consumables necessary for reproducibility of laboratory testing methods, the applicant provides to the applicant service Center of the service provider in quantities sufficient for three-time tests with a residual shelf life of at least six months (except for cases that do not require laboratory tests) (necessarily , job specifications )
- An electronic copy of the document confirming payment by the service recipient of the amount for the examination (necessarily , job specifications )
- Application for recjgnition of the organization or testing Laboratory in form according to Annex 3 hereto (mandatory) (Form of information) (necessarily )(Data form)