On legislative requirements for urgent informing of Roszdravnadzor about adverse reactions and drug safety issues
The Federal Service for Supervision of Health Care again draws the attention of drug circulation entities (medical organizations, holders of registration certificates for medicines), which, in accordance with Article 64 of Federal Law dated 12.04.2010 No. 61-FZ “On the Circulation of Medicines”, medicines that are in circulation in the Russian Federation are subject to monitoring of efficiency and safety in order to identify possible negative consequences of their use, which are individually intolerable usty, warnings of medical workers and patients from the use of such drugs.
The procedure for monitoring the effectiveness and safety, the submission to Roszdravnadzor of information about adverse reactions when using drugs is regulated by the order of Roszdravnadzor dated 02.15.2017 No. 1071 “On approval of the procedure for pharmacovigilance”.
In accordance with the said order, adverse reactions with a fatal or life threat need to be reported within a period not exceeding 3 working days from the date of detection.
In a period not exceeding 15 calendar days, medical organizations should inform Roszdravnadzor of serious adverse reactions, cases of transmission of an infectious disease through a drug, cases of lack of the declared effectiveness of drugs used in diseases that pose a threat to human life, vaccines for the prevention of infectious diseases, drugs to prevent pregnancy when the lack of clinical effect is not caused by individual the patient’s illnesses and (or) the specificity of his illness, as well as adverse reactions resulting from drug abuse, in cases of deliberate overdose of the drug, during exposure associated with professional activity, or in cases of using the drug to intentionally cause harm to human life and health.