A new edition of the Rules for Expert Examination of Medicinal Products and Medical Devices was approved.
Dear Partners and Colleagues!
We would like to inform you that a new edition of the Rules for Expert Examination of Medicinal Products and Medical Devices was approved
The new edition of the Rules for Expert Examination of Medicinal Products and Medical Devices was approved by Order No.ҚР ДСМ-10 of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021.
According to the approved procedure, Chapter 2. «The Procedure for Providing Registration Dossiers for Expert Examination of Medicinal Products» was supplemented with Item 10 to read as follows: The Applicant shall in the event of natural or man-made emergencies, organization and implementation of sanitary-anti-epidemic and sanitary-prophylactic measures and related restrictive measures, including quarantine, when applying for expert examination during registration, re-registration and amending of the registration dossier, provide as part of the registration dossier a letter of guarantee on the provision of documents requiring notarization or apostille, before the completion of the stage of specialized expert examination. The expert examination procedure shall be terminated, should the Applicant fail to provide the notarized or apostilled documents.
With regard to letters of requests from an expert organization, the term shall be considered to have commenced from the date of signing the outgoing request, certified by an electronic digital signature.
Also, at the stage of laboratory testing of medicinal products, specialists of the testing laboratory shall additionally examine the analytical normative documentation for medicinal products to verify test methods. Medicinal products laboratory testing shall be carried out in testing laboratories of the state expert organization in order to confirm the compliance of the medicinal products safety and quality indicators.
If there is no possibility to carry out laboratory testing of medicinal products under individual indicators, the expert organization's laboratory shall acknowledge the results of laboratory testing under individual indicators specified in the certificate (report) of analysis provided by the manufacturer based on the decision of the Expert Council.
According to the updated Order, residual shelf life of medicinal products, standard samples of chemicals, biologicals standard samples, test strains of microorganisms, cell cultures was reduced from 12 to 9 months (except in cases where no laboratory tests are required). When conducting laboratory tests of medicinal products, the Applicant shall expressly and under a certificate of transfer and acceptance provide samples within 5 (five) working days from the date of submission of the application to the Applicant Service Center of the state expert organization (hereinafter the ASC).
It should be noted that in Chapter 6 «Terms of Medicinal Products Expert Examination», the period of confirmation of the authenticity or translation into Kazakh of the medicinal product summary characteristics and Basic Prescribing Information (leaflet), labeling and packaging layouts, labels, stickers was added to in the period of specialized expert examination (ninety calendar days).
The Applicant shall in the course of re-registration submit an application for expert examination under medicinal products re-registration before and (or) within six months upon expiry of the registration certificate.
Manufacturers of the Republic of Kazakhstan shall provide Parts I and II of the List of Appendix 2 to these Rules for expert examination during the medicinal product state re-registration, while foreign manufacturers shall provide Modules 1-2 in accordance with Appendix 3 to these Rules.
The general quality report shall contain an overview of chemical, pharmaceutical and biological information. Module 2 documents cover the issues and describe the relevant data, which are detailed in Module 3. For pharmacopoeial procedures, verification data shall be provided.
The expert organization shall, in case evidence is identified in the course of the expert examination that casts doubt on the accuracy of the information provided in Module 2 of the registration dossier regarding the quality of the medicinal product, request the documents of Module 3.
Appendices 2, 3 to the Rules of the Expert Examination of Medicinal Products were supplemented. For each clinical study (including bioequivalence studies) the following documents shall be provided: an approved study protocol, an approved study report, a regulatory authorization to conduct the study (if any), an ethics committee approval, a copy of the sponsor's liability insurance in case of harm to life and health of a study subject, copies of Case Report Forms (20% for international, multicenter clinical trials), chromatograms (when submitting documentation for a bioequivalence study), copies of contracts between the clinical study sponsor and the study site (contract research organization) (if necessary, after confidential information is withdrawn).