Immediate steps
Product suspected of being falsified should be physically segregated in a clearly identified quarantine area and prevented from entering saleable stock. Chapter 6 treats this as immediate, not contingent on confirming the suspicion.
The suspicion should be recorded at the point it arises, including what prompted it. Suspicions that are resolved as unfounded still belong in the record, because the pattern of what triggers them is useful.
Who to notify
The competent authority and the marketing authorisation holder should be informed without delay. In the UK that means MHRA, and the notification is not deferred until the wholesaler has completed its own enquiry.
Where the product was received from another wholesaler or supplied onward, those parties will also need to be notified so the chain can be reconstructed and any onward stock secured.
What tends to trigger a suspicion
- Packaging, print quality, batch coding or language inconsistent with the expected presentation.
- Product obtained outside the usual supply chain or from a newly approached supplier.
- Documentation that does not reconcile with the physical goods.
- Batch numbers or expiry dates that do not match manufacturer records.
- Price materially below the expected market level.
- Safety features that fail verification where applicable.
Investigation and disposition
The investigation should establish how the product entered the chain, what other stock from the same source or batch exists, whether any of it has been supplied onward, and what recall action is required.
Disposition of suspected falsified product is an RP decision under Chapter 2. Product confirmed or reasonably suspected as falsified should not return to saleable stock, and destruction should be documented and, where required, agreed with the authority.
Relationship to defective products
Falsification and defect are different categories with different routes. A genuine product with a manufacturing quality problem is a defective medicinal product and is handled through the MHRA defect reporting route, which has its own guidance and classification. Procedures should make the distinction clear so staff choose the right path rather than defaulting to one.
Common questions
- Do we notify MHRA before or after we investigate?
- Notification should not wait for the investigation to conclude. GDP expects the competent authority and the MAH to be informed without delay once falsification is suspected.
- Can suspected falsified stock be returned to the supplier?
- Not as a routine disposal route. Returning the product can remove evidence and move the problem elsewhere; disposition should follow the RP decision and any instruction from the authority.
- What if the suspicion turns out to be unfounded?
- The stock can be released through the normal disposition process, and the record should show the basis for the conclusion. Raising a suspicion that proves unfounded is a functioning system, not a failure.