Aggregating individual packs makes sense even if it is not mandatory
In its recently published Delegated Regulation concerning the Falsified Medicines Directive, the EU only requires a code with a unique serial number to be indicated on individual packs containing prescription medicines. The number is registered in a central database, which enables the pharmacist to ascertain whether the medicine is genuine before it is handed over to the consumer. The regulation does not require that the issued codes are aggregated – assigned to bundles, cases and pallets by creating, storing and sharing packaging hierarchies (parent-child relationships). This is or will however become compulsory in some other regions like Turkey, China, USA or Brazil.
Lack of aggregation hampers logistical efficiency
Although some pharmaceutical manufacturers may have been pleased that the EU has not foreseen aggregation, the procedure actually offers considerable benefits. In the absence of any indication of the individual codes contained within a pallet, many logistical processes are more difficult to perform efficiently. If an aggregation hierarchy exists, returns can be processed relatively easily, for example. „Simply reading the pallet code is all that is required to re-enter the codes of all the individual packs into the merchandise management system or connected serialization database“, explains Michael Urso, Product Manager Pharma & Packaging Solutions at Atlantic Zeiser.
Knowing the location of individual products within the logistics chain can also be a critical advantage in recall campaigns. „Manufacturers can then respond quickly and, in particular, without withdrawing unnecessarily large batches from the market,“ says Urso. If products are stolen, furthermore, it is relatively easy to produce „blacklists“ of all the packages that have entered the market illegally.
Wholesalers likely to demand rapid introduction of aggregated data
Even though the EU does not explicitly call for aggregation in its Delegated Regulation, the subtext does appear at least to recommend its introduction.
When medicinal products are being supplied to a public institution and if a wholesaler procures medicinal products other than directly from the manufacturer, the wholesaler must verify the authenticity of every package. According to Recital 19 of the Delegated Regulation, for example, „The authenticity of those medicinal products should therefore be subject to additional verifications by wholesalers throughout the supply chain to minimise the risk that falsified products (entering) the legal supply chain“.
As a logical consequence, the wholesaler would have to scan each individual package if he were unable to verify authenticity by means of a higher-level code indicating the aggregation hierarchy. Recital 20 addresses this problem as well, but in a rather neutral way. It should, it says, „be left to the choice of the wholesaler whether to scan individual unique identifiers or aggregated codes, where available“. In view of their obligations and the considerable time they will need to invest, it is therefore likely to be only a matter of time until wholesalers urge pharmaceutical manufacturers to introduce aggregation. Although partially justified at first, the predominant concern that aggregation would reduce the throughput of packaging lines has been defuisng by high performance vision systems and other equipment for case packers that are also available for retrofitting in existing lines. For relatively small production quantities, moreover, semi-automatic solutions such as MEDILINE CodeCollectM, which in a manual packaging environment use cameras to read all the individual codes in a layer, can serve as packing stations while facilitating ergonomic working practices.