The preparation of a PSAR, also referred to as a Periodic Safety Report, is an important part of the life cycle of any medicinal product. The periodic safety report is designed to minimize the risks of drug use and continually improve the benefit /safety ratio. PSAR are prepared either by special departments of pharmaceutical companies, or prepared by outsourcing firms to order. In this case, they usually provide a full range of pharmacovigilance services.

The preparation of the PSAR is carried out on the basis of the Order of Roszdravnadzor dated February 15, 2017 No. 1071 in the form and within the time frame given in the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU NPF Rules) by holders of registration certificates (DRU) of all medicinal products (MD) registered in the Russian Federation for medical use.

PSAR is submitted by the DRU using the recommended method – automatic registration in the “Periodic Report” section of the Federal AIS database of Roszdravnadzor. Firms providing a full range of pharmacovigilance services also have access to the system. The PSAR assessment is carried out by the expert organization FGBI “IMTSEUAOSMP” of Roszdravnadzor within 60 working days from the date of their receipt. If the submitted PSF is found to be inconsistent with the EAEU NPF Rules, Roszdravnadzor sends the DRU a request to amend the PSF within a period not exceeding 30 working days from the date of receipt of the request.

If adverse reactions and other information on safety and efficacy are detected that are not contained in the instructions for medical use, replacing the ratio of the expected benefit to the possible risk of using the drug, Roszdravnadzor has the right to request an extraordinary PHB from the holder of the registration certificate for the drug.