How to detect Falsified Medicines

Recommendation

3/4 May 2023
Vienna, Austria

The Responsible Person for Good Distribution Practice (GDP)

Despite the current guidance and improvements to detect falsified medicines in the supply chain, cases come up again and again. This is also emphasised by the British supervisory authority MHRA. In their blog "Falsified Medicines and the supply chain", the agency lists ways in which counterfeit medicines can be detected. A kind of checklist can be derived from this:

For deliveries in own vehicles from suppliers

• If a supplier arrives in a rented van, one should evaluate whether there is a justified reason for this or not.
• Boxes should be checked to see if they are unusual or if there are any indications that they may have been stored elsewhere.
• Check whether data loggers or corresponding printouts actually originate from this delivery.
• Does the duration of the journey fit? Are the transit route and conditions known?
• Deliveries in taxis/passenger cars should always be questioned more closely.
• Are rejected goods actually returned to the supplier? Or is the address different than expected?
• Are there any anomalies or even errors in the comparison of the delivered goods to the delivery note?

Large quantities of medicines are unexpectedly available or offered

• Check, why these amounts are now available?
• Is procurement staff trained to understand signs of potentially falsified stock?
• Ensure that all employees feel able to report unusual events to senior management such as the Responsible Person (RP) or the Qualified Person (QP).

There is also a special MHRA guidance available for checking and handling security features.