An internal audit completed by Romania’s Ministry of Health has identified weaknesses in how medicine stocks, consumption and special-needs treatments are monitored. The review found that the electronic reporting system does not sufficiently automate risk alerts, while some authorisation stages were delayed, including for Lomustine. The ministry has issued 16 recommendations covering digital reporting, clearer data responsibilities, supply interruption information and stronger inspections.
Manual checks leave risks detected late
The audit examined the National Agency for Medicines and Medical Devices, along with ministry structures responsible for medicines. It found that the Electronic Reporting System cannot yet identify and flag in real time all risks involving stocks, consumption and information submitted by operators. Monitoring still relies largely on manual analysis, notifications and targeted checks. In procurement and supply-chain terms, this means that a reporting system is being used mainly as a repository rather than as an active control mechanism. The ministry said that this can delay intervention when a medicine may become unavailable. It also found no common, formal operational flow between the ministry and the medicines agency for using the system’s data.
Authorisation and demand planning were also exposed
The review found that public information on interruptions to the supply of some treatments was not always complete or current, making it harder to establish the actual market position of a medicine. Vulnerabilities were also identified in special-needs medicines, including the transmission of information about valid authorisations. The framework for ‘other cases of necessity’ was considered insufficiently clear and capable of producing different interpretations during authorisation. Delays were identified at some authorisation stages, including for Lomustine, which the ministry warned could postpone the provision of required quantities. The audit also found that demand for some national health programmes was not consistently matched against patient numbers, consumption and reimbursement data.
Inspection capacity and supplier data need stronger controls
The audit reported that specialist committees at the Health Ministry or the National Health Insurance House do not always issue the documents needed to classify a treatment as a special-needs medicine within the statutory period. They also do not always communicate estimated demand for 12 months of use. Separately, the medicines agency has limited control capacity relative to the number of units it monitors. The review found few unannounced inspections, creating a risk that missing or inaccurate reports, and differences between declared and physically available stocks, may not be identified quickly enough. For public buyers and suppliers, the transferable lesson is that declared stock needs defined verification routes and timely physical checks.
Sixteen recommendations set out a revised control model
The ministry and medicines agency received 16 recommendations, including automated stock and consumption monitoring, alerts for critical stocks and missing or erroneous reports, and clearly assigned responsibilities for checking data. The audit also called for standardised reporting of supply interruptions, regularly updated public information, closer monitoring of special-needs medicines and authorisation deadlines, and demand estimates linked to patient and programme data. It recommended greater inspection capacity, a plan for unannounced inspections, physical stock verification and consideration of sanctions for failing to report or submitting false data. In September, the ministry also simplified special-needs supply rules: authorisation of an additional quantity may begin when approved stock falls to 30%, rather than the previous 10%, with intervention required within three working days.
| Audit finding | Detail |
|---|---|
| Audit scope | The Health Ministry, the National Agency for Medicines and Medical Devices, and relevant ministry structures |
| Recommendations | 16 measures were issued |
| Stock monitoring | The Electronic Reporting System is not sufficiently automated for real-time risk alerts |
| Demand planning | Some programme needs are not consistently matched with patient, consumption and reimbursement data |
| Special-needs threshold | Additional authorisation may begin when approved stock falls to 30%, compared with 10% previously |
| Response deadline | Intervention is required within three working days of reaching the threshold |
We must move from reacting to anticipating risks, through a digital system in which stocks and consumption are monitored automatically and problems are flagged early.
WHY IT MATTERS
The audit shows why public medicine procurement depends on more than a contract award. Reliable stock data, shared workflows, demand evidence, authorisation deadlines and physical inspections help buyers and suppliers identify shortages before they affect patients. Automated alerts can support that process, but the recommendations also point to governance controls: named responsibilities, standard reporting and regular checks against what is physically held.
Reported from digi24.ro, 2026-10-07. The Tender Wire is published by Otnox.
