The Russian Ministry of Health has submitted for public discussion a draft law that, for the first time, will grant the Ministry of Industry and Trade the authority to conduct unscheduled inspections of pharmaceutical manufacturers. The document has been posted on the federal portal of draft regulatory legal acts (ID 167833), and the discussion will conclude on June 9, 2026.
The essence of the changes
Amendments are being made to Federal Laws No. 61-FZ (“On the Circulation of Medicines”) and No. 99-FZ (“On Licensing”). The current regulation (Resolution No. 686) does not explicitly provide for unscheduled inspections by the Ministry of Industry and Trade when the life and health of citizens are at risk—this gap is proposed to be addressed.
Inspection procedure
The basis is the agency’s receipt of information about potential or actual harm to citizens. The inspection must begin within 72 hours of receipt of the information (the general inspection period is 24 hours, but this takes into account the complexity of pharmaceutical production and the training of inspectors). The manufacturer is not required to be notified of the visit, but the Ministry of Industry and Trade is obligated to inform the prosecutor’s office.
Responsibility for violations
If gross violations of licensing requirements are detected, the following consequences occur:
- suspension of the license for a period of up to 120 days (upon the company’s request, an extension for another 60 days is possible);
- simultaneous suspension of the EAEU GMP certificate;
- If the violations are not corrected within the allotted time, the license and GMP certificate will be terminated within 10 working days after its expiration.
Thus, the company may simultaneously lose the right to produce and sell products on the EAEU market.
