Information for applicants of registration certificates

MEDICINES WITH INDEFINITE REGISTRATION

Information on the procedure of approval of the cost of services for annual evaluation of the benefit/risk ratio for medicines with indefinite registration certificates

Department of Pharmacovigilance and monitoring of safety, effectiveness and quality of medical devices reports that in accordance with Article 63-1. Code of the Republic of Kazakhstan "On Public Health and Health Care System", in force July 07, 2020, "Evaluation of safety and quality of medicines and medical devices registered in the Republic of Kazakhstan is carried out by determining the conformity of safety and quality of medicines and medical devices to registration dossier, regulatory documents on quality on the basis of which they were registered in the Republic of Kazakhstan.

2. Assessment of safety and quality of medicines and medical devices registered in the Republic of Kazakhstan falls within the state monopoly and is carried out by the state expert organization in the field of circulation of medicines and medical devices.

Prices for goods (works, services) produced and (or) sold by the subject of state monopoly shall be set by the authorized body in coordination with the anti-monopoly authority".

Currently a price list for the provision of services to perform an annual assessment of the benefit-risk ratio of medicines with an indefinite registration certificate is being coordinated with the relevant authorities. Information on the results of price approval will be available at www.ndda.kz.