One line, forty regulations

More than forty countries have passed medicine track-and-trace legislation, and they did not coordinate. The result is a set of requirements that overlap but never quite match. A manufacturer exporting to several of them ends up reconciling several systems rather than implementing one.

The divergence is usually discovered late, once the equipment has been specified and the layout drawn. The typical moment is a packaging engineer, a few months before FAT, receiving an email from the export team about a new market that wants cases and pallets reported. The question belongs at the start.

The four axes of divergence

Memorising every national rule is a losing game. It is more useful to know the four dimensions along which they differ; any new market can then be placed on them in an afternoon.

• What the code carries. Most markets converge on a GS1 Data Matrix with product code, serial number, batch and expiry. Some require additional national elements. At least one, Russia, requires a cryptographic element issued by the state, which changes the code length and the way numbers are obtained.
• Who issues the serial numbers. In the EU, the manufacturer generates them, following randomisation rules. In several markets they are issued by, or registered with, a state authority before printing. That difference reaches well beyond a parameter in the serialisation software. It changes the architecture between your Level 3 and Level 4 systems, and it puts an external dependency on the line.
• Whether aggregation is mandatory. The EU does not require it; aggregated codes are allowed, and wholesalers may use them where they exist. Several markets do require it, at case and pallet level, with the parent-child structure reported. A line built without aggregation stations cannot acquire them cheaply later, because there is rarely floor space where they would need to go.
• What has to be reported, and when. Anything from a single initial upload, through shipping and receiving events, to full event reporting at every change of custody. This axis has the largest IT consequence and the least visibility at specification time.

Why this is a line decision

It is tempting to treat market divergence as a software configuration matter. Two of the four axes are physical.

Aggregation needs stations: a bundle station, a case station with a reader, a pallet labelling station, and the conveyor length to hold them. Fitting them into a line laid out without them usually means re-laying the line, with a shutdown, a requalification and a capital request nobody planned.

State-issued serial numbers need a permanent, reliable path from the line to an external service, and a defined behaviour when that path is down. That is network and continuity design, and it constrains where the line can sit on your network.

So a line designed for one market rarely stretches to five. More often it gets rebuilt for the second.

The questions to settle before buying equipment

1. Which markets in five years, and not only today? Export plans are commercial information that engineering rarely asks for, and they are the single most valuable input to this decision.
2. Are you a CDMO or contract packer? If so you inherit your customers’ markets, not your own, and nobody will tell you about them in advance. Your baseline has to be the strictest requirement you might plausibly face.
3. Aggregation now or never? Floor space makes "later" expensive. Decide whether the stations go in, even if the data is not reported at first.
4. What happens when the external service is unreachable? For every market whose numbers come from outside, the answer must exist before the line is commissioned.
5. Who owns the reporting formats? Each market has its own. Someone has to maintain them as they change, and that person is usually not named until the first change arrives.

The reasonable strategy

Design the physical line for the strictest scenario you can justify, aggregation stations included, and keep the market-specific behaviour in software, at Level 3 and Level 4, where it can be changed without touching stainless steel.

It costs more at the start. A lot less, though, than the second line.

References

• Commission Delegated Regulation (EU) 2016/161 on the safety features on the packaging of medicinal products for human use (unique identifier, randomised serial numbers, optional aggregated codes). eur-lex.europa.eu