In accordance with paragraph 1 of Article 64 of the Federal Law dated April 12, 2010 № 61-FZ “On Circulation of Medicines” medicines which are in circulation in the territory of the Russian Federation are subject to safety monitoring to reveal possible negative effects resulted from their use, to prevent and to protect patients from use of such medicines.
In accordance with the Resolution of the Government of the Russian Federation № 650 “On Making Amendments to Certain Legal Acts of the Russian Federation due to Adoption of the Federal Law dated August 20, 2010 “On Circulation of Medicines” Roszdravnadzor exercises its state-mandated function of monitoring of the safety of medicines which are in circulation in the territory of the Russian Federation.
Pursuant to the Federal Law dated April 12, 2010№ 61-FZ “On Circulation of Medicines” (Art.64) the subjects of circulation of medicines should provide Roszdravnadzor with information of any cases of side effects, which are not specified in a package leaflet for medicines, of serious adverse events and unexpected adverse events which have occurred when administering the medicines, and of particularities of interaction of the medicines with other medicines registered in clinical trials, as well as when administering medicines.
Besides, in compliance with the Order of the Ministry of Healthcare and Social Development (Minzdravsotsrazvitiya) of Russia dated August 26, 2010 № 757н “On Approval of the Procedure of Safety Monitoring of Medicines for Medicinal Use, Record of Side Effects, Serious Adverse Reactions and Unexpected Adverse Reactions when Administering Medicines for Medicinal Use” within the safety monitoring of medicines Roszdravnadzor conducts an analysis of periodical reports on safety of medicines, provided by manufacturers and developers.
In accordance with the Order of the Ministry of Healthcare and Social Development (Minzdravsotsrazvitiya) of Russia dated August 26, 2010 №757н Roszdravnadzor analyzes information obtained through safety monitoring. The results are sent to the Ministry of Health (Minzdrav) of Russia to take decisions on making amendments to a package leaflet of medicines, as well as on suspension of circulation, withdrawal from circulation or renewal of circulation of medicines.