All medicines manufactured in the Russian Federation and imported into the Russian Federation are subject to federal state control over circulation of medicines (hereinafter referred to as - state control). The procedure of state supervision is established by the Federal Law dated April 12, 2010 № 61-FZ “On Circulation of Medicines” and other regulatory legal acts of the Russian Federation thereunder.
The main functions of the state control are prevention, detection, suppression of violations of the legislation of the Russian Federation for circulation of medicines in the course of activity of the subjects of such circulation.
The state control is performed by the Federal Service for Surveillance in Healthcare (hereinafter referred to as - Roszdravnadzor) and by territorial authorities in the constituent entities of the Russian Federation according to the procedure established by paragraph 5.1.4 of the Resolution of the Government of the Russian Federation dated June 30, 2004 № 323 “On Approval of the Regulations on the Federal Service for Surveillance in Healthcare”.
The state control includes organization and conducting of inspections of the subjects of circulation of medicines for compliance with the requirements for storage, transportation, dispensation, distribution of medicines and administration of medicines.
Activities related to state control, organization and conducting of inspections of the subjects of circulation of medicines are subject to the Federal Law dated December 26, 2008 “On Protection of Rights of Legal Entities and Individual Entrepreneurs When Exercising State Control (Supervision) and Municipal Control”.
Control over completeness and quality of state supervision includes carrying out inspections, detection and elimination of violations of applicants rights, taking measures for suppression of violations of mandatory requirements and (or) elimination of such violations, examination, taking decisions and preparation of answers to addresses of applicants.
If violations of the legislation have been reported based on the results of such inspections persons guilty of violating shall be held liable by the Laws of the Russian Federation.