Systech and Videojet link up for Brazilian serialisation

Two specialists in serialisation and track-and-trace systems - Systech and Videojet - have formed a partnership to help pharmaceutical companies meet Brazil's new medicine traceability regulations.

Under the terms of the deal, Videojet Brazil will sell, install and support Systech's serialisation systems, including its Serialised Product Tracking (STP) package which is already employed in many top pharmaceutical companies.

Companies have already started purchasing and implementing systems to help meet the Brazilian government's track-and-trace requirements, and although there is still considerable debate about the exact form these will take, it seems almost certain that at the core will be a randomised, serial number for each medicine pack sold in the country, carried via a GS1-compliant 2D datamatrix code.

Brazil's plans were first unveiled last year in Law 11.903, which required the "tracking of manufacturing and consumption of medicine by means of data capturing, storing, and electronic transmission technology." The aim is to combat unregistered, stolen, counterfeited and smuggled pharmaceutical products, as well as help prevent reimbursement fraud.

Since then, the national regulatory authority ANVISA has fleshed out the details of the serialisation regime and also added requirements for a co-located holographic safety label. At the moment the suggestion is that this safety label has been dropped (see Brazil may swap its serialisation scheme for Turkish model).

The pharmaceutical industry had been lobbying for a system based simply on serial numbers for traceability, arguing that this strikes a good balance between ease of implementation and improving the security of the supply chain.

Systech SPT serialises products at the item, case, and pallet levels and allows bi-directional communication between the packaging line and a central database, so is aligned for the traceability model proposed in Brazil which would track transactions via a government data repository.

Videojet has good links into the local pharmaceutical market, and was involved in the serialisation pilot project carried out for ANVISA last year by ETCO, the Brazilian Institute for Ethics in Competition.

ETCO's feasibility study did not examine the use of a combined security label, and simply applied 2D datamatrix codes to a test sample of around 75,000 medicine packs supplied by seven national and multinational drugmakers including Bayer, Pfizer and Sanofi-Aventis.

Meanwhile, Systech has implemented more than 150 serialisation projects worldwide and has worked with the top 21 global pharmaceutical companies.

"The combination of Systech's software and Videojet's local support will help meet our customers' immediate serialisation initiatives," said Joe Ringwood, chief operating officer of Systech.


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Safety in numbers: Brazil's medicine serialisation initiative