Information for Professionals

1. TERMS AND DEFINITIONS

1.1. Pharmacovigilance is defined as the activities concerned with the detection, assessment, and prevention of adverse events/reactions to drug products.

1.2. The goals of the pharmacovigilance (including the goals of drug manufacturer/marketing authorization holder) are risk assessment of medical use of the drug and early prevention of identified risks as defined by international regulations.

1.3. Drug products are substances used to prevent, diagnose, and cure a disease or prevent a pregnancy. These substances can be obtained from human or animal blood, plasma, and organs as well as from plants and minerals by synthesis or using biotechnologies.

1.4. Adverse Event (AE) is any undesirable experience (health problem) or any unlabeled event (including favorable ones) occurring during the use or after the use of drug product in a patient (or clinical study subject).

1.5. Adverse/side drug reaction is any harmful reaction associated with the use of drug product in normal doses used to prevent, diagnose, or cure a disease, as well as to change physiological functions.

1.6. Unexpected adverse drug reaction is adverse drug reaction (including reactions associated with the use of drug product in accordance with product label) the nature or severity of which is not consistent with the product information in the product label.

1.7. Serious Adverse Event (SAE)/Drug Reaction is any adverse drug event of patient or subject clinical research occurring at any dose that results in any of the following outcomes:

• death;
• life-threatening adverse drug experience;
• inpatient hospitalization or prolongation of existing hospitalization;
• persistent or significant disability or incapacity;
• congenital anomaly or birth defect.

 

Any important adverse event that is not immediately life threatening or do not result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the undesirable outcomes, should also be considered serious.

2. GENERAL

Drug manufacturer or marketing authorization holder is obliged to identify, collect, and analyze all reports of adverse drug events/reactions occurring during the use or after the use of drug product, and to notify the national regulatory authority (Federal Service on Surveillance in Healthcare and Social Development of Russian Federation) of all known adverse events occurred in the Russian Federation and abroad within the time limit set by the legislation of the Russian Federation.

3. REPORTING REQUIREMENTS

3.1. Adverse drug event/reaction reports

Adverse drug event/reaction reports obtained from drug circulation subjects in the Russian Federation should be submitted electronically to the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation via www.roszdravnadzor.ru with submission (if applicable) of CIOMS report to pharm@roszdravnadzor.ru.

3.2. Drugs which are being clinically studied in Russia

Information on adverse drug events/reactions, related to the drugs being studied in the Russian Federation, from any country should be submitted to appropriate ethics committee.

Primary and secondary data on adverse drug events/reactions should be submitted to the national regulatory authority within the time limit set by the legislation of the Russian Federation - as soon as possible but no more than 15 consecutive days.

3.3. Drugs that are being circulated in the Russian Federation (registered drug products)

Primary and secondary data obtained from drug circulation subjects and related to the adverse drug events/reactions occurred in the Russian Federation, should be submitted to the national regulatory authority to the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

3.4. Primary and secondary data on adverse drug events/reactions should be submitted to the national regulatory authority within the time limit set by the legislation of the Russian Federation - as soon as possible but no more than 15 consecutive days.

4. THE LEGAL FRAMEWORK OF PHARMACOVIGILANCE

4.1. Federal Law N 61-FZ “On Circulation of Medicines” d/d April 26, 2010 as amended up to November 25, 2013, Chapter 13 “Safety Monitoring of Medicinal Products Being in Circulation in the Russian Federation”.

4.2. Federal Law N 152-FZ “On Personal Data” d/d July 27, 2006.

4.3. Order 757-n of Ministry of Health and Social Development of the Russian Federation d/d August 26, 2010 on “Safety Monitoring of Drug Products for Human Use, Registration of Adverse Events, Serious Adverse Events and Unexpected Adverse Events Associated with the Use of Drug Products for Human Use”.

4.4. PSUR Preparation Guideline for Developers and Manufacturers of Drug Products being in Circulation in the Russian Federation.

4.5. Guideline “Interaction Algorithm for Pharmacovigilance System Participants on Identification and Handling of Spontaneous Reports” d/d October 22, 2009.

4.6. GVP modules, EU d/d December 13, 2012.