When a regulator launches a national hub ,the market already has millions of packs in circulation without serial numbers or reporting events.
So,
Do we serialize and report all existing stock?
Or do we start compliance only for new goods after a defined deadline?
Two Main Approaches
1. Full Stock Serialization (“Grandfathering” Model)
All current products available in stock in warehouses and pharmacies must be reported and uploaded to the national hub.
Pros
-100% visibility from day one.
-No “mixed market” of serialized and non-serialized packs.
Cons
-Extremely costly and resource-heavy.
-Logistically difficult for wholesalers and pharmacies (e.g., relabeling thousands of SKUs).
-Risk of mistakes in re-aggregation.
2. Forward-Looking Reporting (Most Common Model)
-Regulator sets a deadline (go-live date).
-Only products manufactured, imported, or received after this date must be serialized and reported.
-Existing stock continues to move without serialization until it is naturally consumed.
Pros
-Less disruption to market supply.
-Easier for stakeholders to implement.
-Aligns with production and import cycles.
Cons
-Transition period → market has both serialized and non-serialized products.
-Regulators have limited visibility until old stock is consumed.
Example
Tatmeen the national UAE compliance platform follow this model.
Operational Perspective
Manufacturers: Must ensure new batches after deadline are serialized and reported to the hub.
Wholesalers: Need processes to separate serialized vs non-serialized stock during transition.
Pharmacies: Must be able to verify serialized products, but also dispense older non-serialized packs until depletion.
Best Practice Recommendation
- Most regulators prefer forward-looking compliance with a grace period.
- This avoids supply disruption while gradually reaching full visibility.
- To smoothen the transition through Clear cut-off dates for import/manufacture.
- Grace periods for depletion of non-serialized stock.