The pharmacovigilance system in the EAEU member states is regulated by Decision No. 185 of 29.12.2015 “On Approval of the Rules of Good Pharmacovigilance of the Eurasian Economic Union”. 

The Marketing Authorization Holder must establish and maintain the pharmacovigilance system. For this purpose, a qualified person responsible for pharmacovigilance (hereinafter referred to as the “QPPV”) with the required qualification is designated. In case if MAH is not an EAEU resident, then a local contact person (LCP) within the territory of EAEU member states should be designated. 

A detailed description of the Pharmacovigilance System Master File (PSMF) and Risk Management Plan (RMP) be submitted to the competent authority. The PSMF must be located within the Member States, either at the place where the main pharmacovigilance activity is carried out or at the place of location of QPPV. The competent authority of the member state should be informed of the location of the Master File.

Name, contact details and CV of the LCP and QPPV are submitted as part of the Application and dossier for registration/renewal. Change of the LCP or QPPV is carried out as type IA variations.

Marketing Authorization Holder should periodically generare the Periodic Safety Update Report (PSUR). The PSUR may be submitted to the competent authority in Russian or in English, with mandatory translation into Russian of the following sections: summary, integrated benefit/risk analysis and conclusions. 

Frequency and timelines of PSUR submission are: 

• every 6 months from the international registration date during the first 2 years;
• annually for the following 2 years;
• further every 3 years.

The competent authority has the right to inspect the pharmacovigilance system of the MAH, both locally and globally. The inspection is carried out for compliance with the EAEU requirements to Good Pharmacovigilance Practice.

Routine pharmacovigilance includes the following actions by the QPPV or/and LCP:

• Maintenance of the pharmacovigilance database; 
• 24/7 monitoring of adverse events (hereinafter referred to as “AEs”) at the territories of EAEU member states from different sources (information from medical representatives, direct requests from physicians and patients etc.);
• Providing timely information to the competent authorities of EAEU member states regarding all reportable AE’s (see below); 
• Local specialized medical literature monitoring; 
• Obtaining timely information from the competent authorities of EAEU member states regarding all serious AE’s of the medicinal product (disability, death, and other serious AEs). This information can lead to the initiation of risk minimisation measures (for example, amending the instructions for human use) and should be distributed among the regulatory authorities of other countries;
• Obtaining retrospective information from the competent authorities of EAEU member states to form a registration dossier for registration/renewal of the medicinal product in other countries;
• Providing timely information to the competent authorities of EAEU member states regarding the lack of efficacy of the medicinal product in the treatment of life-threatening conditions, emergency conditions and conditions in which the absence of effect can threaten the patient’s life;
• Submission of PSUR according to the approved timelines; 
• Cooperation with the the competent authorities and other entities on different inquiries related to pharmacovigilance;
• Submission of RMP (Risk Management Plan) during registration/renewal of medicinal products, in the case of changes requiring a new registration, in the case of emergence/identification of new risks, at the request of the regulatory body;
• Training of the medical representatives and other employees of the MAH at the territory of EAEU member states; 
• Participation in the audit of the pharmacovigilance system by the competent authorities of EAEU member states. 

The MAH timelines for submission of information on AE’s: 

• serious adverse reaction in the territory of the EAEU member state: within 15 calendar days from the receipt of information;
• adverse reaction in the territory of the EAEU member state: within 15 calendar days from the moment of the occurrence of the event;
• serious unexpected adverse reaction to the investigational medicinal product in the EAEU member state, identified in clinical trials, if it caused death or life-threatening condition: within 7 calendar days from the date of receipt of information;
• for other cases of a serious unexpected adverse reaction to the investigational medicinal product in the territory of the EAEU member state: up to 15 calendar days from the date of receipt of information;
• serious unexpected adverse reaction that occurred outside the EAEU member state and was fatal and (or) life-threatening: within 15 calendar days from the date of receipt of the information.

Cratia provides professional services on establishment and maintenance of the pharmacovigilance system in EAEU. We have an excellent knowledge of national legislation, necessary experience and resources. 

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.