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Pharma Plant Licenses May Now Be Suspended For Gross Violations
['Angela Antonova', 'Yury Bocharov', 'Lyuba Lulko', 'Andrey Nikolaev']
PravdaReport
Pharma Plant Licenses May Now Be Suspended For Gross ViolationsThe State Duma has passed a bill in its third reading that tightens control over pharmaceutical manufacturers.
These changes provide regulators with tools to react quickly to violations that pose threats to patient safety.
If violations are not resolved within this timeframe, the license and certificate will be terminated within ten days.
Additionally, the law legalizes the import of samples collected during inspections of EAEU (Eurasian Economic Union) production sites to verify compliance with GPP (Good Production Practice) rules, removing previous customs delays.
Its effectiveness depends on Roszdravnadzor's resources for inspections and future judicial practice regarding license suspensions.