Gearing up for FMD in the European Union

On 2 January, 2013, member states must begin implementing the European Union Falsified Medicines Directive 2011/62/EU, which requires obligatory identification and authentication features on the outer packaging of medicines. Once transposed into national law, manufacturers have three years to comply with the Directive, which for many will entail upgrading production lines to accommodate sophisticated coding and image-recognition systems capable of working at high speeds

Craig Stobie, Lifesciences Sector Manager for Domino Printing Sciences, looks at European serialisation regulation and timings

In less than a year, on 2 January, 2013, member states must begin implementing the European Union Falsified Medicines Directive 2011/62/EU, initially by transposing it into national laws. Manufacturers then have a further three years to comply with the Directive, the principal demands of which include obligatory identification and authentication features on the outer packaging of medicines.

Given that the Directive was only adopted in July last year, the timetable was always going to be tight, particularly as the European Commission has still to decide on the precise form of the identification and authentication process. For example, what will be the characteristics and technical specifications of the ‘unique identifier’ each pack must carry? How much data will the serialisation number hold, and will it be carried on a linear barcode, an EC200 2D Datamatrix barcode, or an RFID tag? And how will the unique identifier be verified against the ‘repository’ (ie, the database) of numbers?

Given that the Directive was only adopted in July last year, the timetable was always going to be tight, particularly as the European Commission has still to decide on the precise form of the identification and authentication process

Without answers to these and other questions member states cannot legislate for FMD, and manufacturers, wholesalers and pharmacists cannot invest in the systems they will need.

Knowledge about FMD is greater following the recent publication by the Commission of a consultation paper asking for industry views on ID and authentication.1 The paper is an essential preliminary to an impact assessment on the characteristics of the unique identifier, the verification procedures and the repositories.

While still short on concrete details, it reveals the thinking of the Commission on the options from which the final solution will be constructed. For instance, while it believes the specification of the tamper-evident feature can safely be left to each manufacturer, the make-up of more complex components must be set. If the spec of the unique identifier were left to manufacturers, it might be cost-neutral but would lead to ‘a high degree of fragmentation of product coding in the EU’.

The paper also makes clear the balance that will have to be struck between the most elegant solution and the most practical: a linear barcode carries less information but almost every European pharmacy has the readers; a 2D Data-matrix barcode carries a lot of data in a small area, but many pharmacies would need to buy a reader.

Allowing time for the responses to the paper to be considered means the final shape of the compliance infrastructure won’t be clear until perhaps six months before the deadline for national legislation

Allowing time for the responses to the paper to be considered means the final shape of the compliance infrastructure won’t be clear until perhaps six months before the deadline for national legislation. But manufacturers don’t have to wait to start building FMD-compliant solutions: a lot is already known, both from the assumptions in the consultation paper and from the experiences of similar deployments in countries such as Turkey and France.

We know there will be no ‘off-the-shelf’ solutions, because the FMD will govern a complex industry across a number of countries. On the subject of verification, for example, the FMD must take into account the different characteristics of each nation’s supply chain so that the impact of verification measures are proportionate.

Things will be complex in the production plant too. Under FMD, manufacturers will be responsible for generating and managing the enormous volumes of data that random code generation and verification entail, which means upgrading production lines to accommodate sophisticated coding and image-recognition systems capable of working at high speeds. According to some estimates, up to 80% of the coding solutions currently used in pharma and healthcare will be rendered obsolete by FMD, and because few companies can afford totally new production lines, the technology will have to be retrofitted. This is difficult on lines where space is at a premium, and also calls for innovation in integrating different interfaces.

Under FMD, manufacturers will be responsible for generating and managing the enormous volumes of data that random code generation and verification entail

Because FMD calls for so many different disciplines, developing solutions will be a team effort, requiring specialists in coding, imaging, data management, handling, etc. This will take time. Based on Domino’s experience, it can take six months to decide on vendor partners, anything up to a year to set up and test the pilot packaging line, and a further year to upgrade other lines, each of which will differ slightly from the pilot.

So team selection needs to start now. Whatever form the solution finally takes, there are a number of ‘core competencies’ that the team must have such as smart camera technology capable of reading data-rich codes at production line speeds, at a variety of orientations, in a range of environments. Laser scanners cannot process the amount of data in a 2D Datamatrix barcode, so image-based automatic ID readers are needed. The system has to be secure to comply with GAMP 5 and 21-CFR 11: features such as password-protected interfaces are essential. Inks need to be fade-resistant and capable of standing up to a range of harsh conditions.

Furthermore, the scope of the FMD means that the challenges will now have to be overcome by all companies – generics manufacturers, contract packers, re-packers and importers.

reference

1. http://ec.europa.eu/health/files/counterf_par _trade/safety_2011-11.pdf

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