Article 14. Principles of Expert Examination of Medicines and Ethical Expert Examination

1. Expert examination of medicines and ethical expert examination are based on the principles of legality, observance of human and citizen rights and freedoms, legal entity rights, expert independence, objectiveness, comprehensiveness and completeness of the trials conducted using the latest achievements of science and technology, responsibility of the federal state-financed institution for carrying out expert examination of medicines and responsibility of experts for performance and quality of expert examination.

2. Expert examination of medicines is carried out on a staged basis:

1) first stage: expert examination of documents submitted to obtain a permit to conduct a clinical trial of a medicinal product, excluding:

a) medicinal products permitted for medical use in the Russian Federation for over twenty years, for which bioequivalence study can not be conducted;
b) medicinal products for medical use for which international multicentre clinical trials have been conducted, partially on the territory of the Russian Federation;

2) second stage: expert examination of proposed methods of a medicine quality control, expert examination of the quality of medicine samples submitted using those methods (hereinafter – the “expert examination of the quality of a medicine”), and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product carried out after its clinical trial has been conducted.

3. Expert examination of medicines for veterinary use is carried out on a one stage basis and involves expert examination of the quality of the medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product.