Roszdravnadzor is strengthening control over pharmaceutical organizations in terms of entering data into the “Federal Register of Medical Organizations” (FRMO). Previously, inspections concerned mainly medical institutions, but now pharmaceutical organizations are also under close scrutiny.
What do they check?
– Completeness and reliability of data in the FRMO (for example, information on equipment for pharmaceutical activities).
– Compliance with licensing requirements – failure to provide data may result in fines or suspension of operations.
What are the consequences of violations?
According to Part 4 of Article 14.1 of the Code of Administrative Offenses of the Russian Federation:
– Fine from 100 to 200 thousand rubles
– Suspension of activities for up to 90 days
Why do problems arise?
– ~40% of pharmaceutical organizations * have not yet entered complete data into the FRMO.
– The system is not adapted for pharmaceutical companies – technical difficulties arise.
– Industry associations have already contacted Roszdravnadzor for help in resolving these issues. Pharmaceutical organizations should urgently check their data in the FRMO to avoid fines and suspension of activities. If there are technical problems, you can contact industry associations or directly to Roszdravnadzor.
