The Russian Government has approved a new resolution updating the procedure for licensing pharmaceutical manufacturing. The document, prepared by the Ministry of Industry and Trade, aims to digitalize supervision, introduce a risk-based approach, and significantly reduce administrative timelines for manufacturers.
Key Takeaways:
- Authority: Government of the Russian Federation.
- Main Goal: Digitalization of supervision and reduction of bureaucracy.
- New Timeline: License issuance in 27 days (down from 30).
- Innovation: Remote inspections via the “Inspector” mobile app.
- Risk Model: High-risk facilities inspected annually; low-risk exempted from planned checks.
Risk-Based Approach and Categories
The new regulations introduce a risk-oriented model for licensing control. Manufacturing facilities are now categorized into risk levels, which determine the frequency of inspections:
- High Risk: Planned inspections once a year.
- Medium Risk: Inspections once every 3 years.
- Low Risk: Exempt from planned inspections.
Risk criteria are calculated based on specific indicators. For example, if a manufacturer has been denied a license twice within a year due to non-compliance, they receive 4 risk points.
Digital Supervision and Remote Inspections
The state control system is now officially integrating the “Inspector” mobile app. This allows preventive visits and even on-site inspections to be conducted remotely using video conferencing (VCS) and photo/video recording features.
Reduced Timelines for Manufacturers
The Government has streamlined the provision of state services. The timeline for issuing a pharmaceutical manufacturing license has been reduced to 27 working days (previously 30). For veterinary medicines, the period is set at 30 days.
In specific cases — such as operations limited to packaging, storage, or release control at a single address — the timeline for issuing a license or amending the registry is cut to just 12 working days.
| Key Change | Details |
|---|---|
| License Issuance Time | Reduced to 27 working days |
| Expedited Procedure | 12 days (for packaging/storage only) |
| Remote Inspections | Allowed via “Inspector” app |
| Planned Inspections | Abolished (except for High Risk facilities) |
| Appeal Process | Review time reduced from 20 to 15 days |
Appeal Mechanism
To protect business rights, a special collegiate body will be established under the Ministry of Industry and Trade to review complaints regarding departmental decisions. The review period for such appeals has been shortened from 20 to 15 working days.
Source:
Decree of the Government of the Russian Federation No. 2143 dated December 25, 2025
