In order to ensure transparency of its activities when providing recommendations for state registration of medicinal products, the Center has introduced the publication of information reports on the results of the expert evaluation of registration materials for medicinal products submitted for state registration (Public Reports).
This Public Report is intended for the general public – consumers, healthcare professionals, public organizations, manufacturers and representatives of manufacturers of medicinal products, etc. – and has been prepared for the purpose of providing information about a registered medicinal product.
The Public Report contains information, with the exception of confidential information, on the content of the data provided to confirm the safety, efficacy and quality of medicinal products, and the conclusions of the experts regarding the assessment of these data. The annexes to the Public Report contain publicly available information about the medicinal product – the instruction for medical use, data on the type of packaging, labelling, shelf life, manufacturer, etc., as well as, if available, a summary of product characteristics.
