Pharma Plant Licenses May Now Be Suspended For Gross Violations

The State Duma has passed a bill in its third reading that tightens control over pharmaceutical manufacturers. The legislation amends three federal laws regarding state control (No. 248-FZ), the circulation of medicines (No. 61-FZ), and licensing (No. 99-FZ). These changes provide regulators with tools to react quickly to violations that pose threats to patient safety.

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A hospital doctor

A primary update is the introduction of a mechanism to suspend manufacturing licenses. If Roszdravnadzor detects gross violations creating a significant risk of producing medicines dangerous to life or health, the regulator may suspend the manufacturer's license or GMP (Good Manufacturing Practice) certificate for up to 120 days. Manufacturers can apply to extend this period by another 60 days to rectify the issues. If violations are not resolved within this timeframe, the license and certificate will be terminated within ten days.

The amendments also clarify the procedure for withdrawing and destroying batches of drugs from circulation, including based on pharmacovigilance results. 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.

Clinical pharmacologist Aleksey Ryabtsev noted that license suspension is a precautionary measure rather than a fine. He stated that when health risks are involved, the regulator must have the right to stop production until circumstances are clarified, adding that the fixed timelines balance patient protection with the manufacturer's right to correct errors.

The law takes effect ten days after official publication. Its effectiveness depends on Roszdravnadzor's resources for inspections and future judicial practice regarding license suspensions.