ГлавнаяDocumentsMedical product approval Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 6 Performance of State Registration of Medicinal Products - Article 25. Repeated Expert Examination of Medicines and Repeated Ethical Expert Examination
Article 25. Repeated Expert Examination of Medicines and Repeated Ethical Expert Examination
1. In case of insufficient feasibility or incompleteness of the conclusion issued by the expert institution or ethical council, presence of controversial data in such conclusion, falsification of the inferences based on the results of expert examination of a medicine and (or) ethical expert examination, concealment from the authorized federal executive body of any grounds for rejection of an expert due to his being interested in the results of the relevant expert examination, availability of data on direct or indirect interference in the expert examination procedure of any persons not participating in the performance thereof, however having influenced the procedure and the results thereof, the authorized federal executive body shall schedule repeated expert examination of the medicine and (or) repeated ethical examination.
2. Repeated expert examination of a medicine shall be carried out within the period prescribed by the authorized federal executive body, not exceeding forty business days from the date of receipt by the expert institution of an assignment to carry out repeated expert examination of the medicine; repeated ethical expert examination shall be carried out within the period not exceeding fifteen business days from the date of receipt by the ethical council of an assignment to perform repeated ethical expert examination.
3. Financing of repeated expert examination of a medicine is not provided, and the funds transferred for the performance of such expert examination earlier are subject to return to the federal budget.