The European Medicines Verification System (EMVS) employs a hierarchical structure to manage pharmaceutical product statuses across three levels: Product State, Batch State, and Pack State. Understanding these statuses and their implications is crucial for maintaining compliance and ensuring patient safety throughout the supply chain.
Status changes affect all lower levels in the hierarchy. For example, withdrawing a product affects all associated batches and packs, making them non-dispensable.
Product is authorized for distribution and dispensing
Product removed from market
Product State changes affect all associated batches and packs. A withdrawn product makes all related items non-dispensable.
Batch is available for distribution and dispensing
Batch removed due to safety concerns
Batch State changes affect all packs within that batch. A recalled batch decommissions all associated packs.
Pack is available for dispensing
Pack has been dispensed to a patient
Pack designated for export outside EEA
Pack temporarily locked in system
Pack reported as stolen
Pack designated as a sample
Pack has been destroyed
Pack temporarily removed for quality control
Pack has reached its expiration date
Mapping real-world scenarios to system statuses
| Scenario / Action | Required System Status | Reversible? | Notes |
|---|---|---|---|
| Dispensing medicine to a patient | Supplied | Yes (10 days) | Standard pharmacy action |
| Shipping to Non-EU Country | Exported | Yes (10 days) | Must be done before shipment leaves |
| Pack is broken, damaged, or discarded | Destroyed | NO | Physical pack should not exist afterwards |
| Providing to authorities (e.g. Police/Ministry) | Sample | Yes (10 days) | For official sampling or analysis |
| Theft discovered or reported | Stolen | NO | Triggers immediate high-level alert |
| Temporarily moving stock (no change of ownership) | Locked | Yes (Anytime) | Prevents dispensing while investigating |
Always verify product status before performing any status changes to ensure compliance.
Remember the 10-day limit for pack decommissioning reversals and act promptly when needed.
Exercise extreme caution with withdrawals and recalls as these actions cannot be undone.
Understand your entity's specific permissions and stay within authorized actions.
Information may be outdated. Always consult official documentation from EMVO, EMA, GS1, and national regulatory bodies for current requirements.