Serialisation using labels

According to the FMD 2011/62, serialisation of all prescription drug packs in Europe will inevitably become a daily routine for the pharmaceutical industry from 2019. European Biotechnology spoke with Philip Falkenstein, Product Manager at Bähren Druck, about the use of pre-serialised labels as solution for special implementation areas and the current legal framework.

EuroBiotech_ Usually, a pharmaceutical company buys equipment to serialise pharmaceutical packaging in its production line. When should serialised labels be considered?
Falkenstein_ Correct, the majority of packages are serialised inline. However, there are plenty of areas in which standardised systems and processes – technically, economically, or organisationally – reach their limits. In these situations, the use of pre-serialised labels comes into play.

EuroBiotech_ What areas and situations?
Falkenstein_ Special serialisation cases such as: bundle or so called clinical packs, oversized packaging dimensions, overweight packs, small and medium quantities, manual packaging, backup or even as a standard solution to avoid high technical investment. Our page www.your-special-case.com provides further details.

EuroBiotech_ As serialisation data need to be exchanged, how is this handled?
Falkenstein_ The use of pre-serialised labels requires a clear agreement between the pharma company and us. Defining the main questions relating to the serial numbers, data interfaces, and reporting is an important task, and will be addressed during our onboarding process.

EuroBiotech_ Regarding compliance: is the use of labels generally accepted?
Falkenstein_ All pre-serialized labels are produced under GMP conditions. Internal as well as customer audits verified the process. Furthermore, each label is controlled by a camera system in order to verify the barcode grading and the serial number documentation. From an organisational and technical point of view, we´re ready to onboard further customers. Unfortunately, there were inconsistencies about the general use of pre-serialized labels. Directive 2001/83 Article 56 allows the labelling of the security feature. However, a Q&A paper on safety features, which is continuously updated by the European Commission, has caused confusion. It states the use of labels will be acceptable when “no technically feasible alternative” exists, which leaves much room for interpretation. Alternatively, member states should decide in a given case if labels are an appropriate solution, the Commission suggested.

EuroBiotech_ Has there been a reaction yet?
Falkenstein_ In Germany, the authorities have recently officially accepted the use of labels. We assume that this is the beginning and that other national authorities will follow.

EuroBiotech_ Do you think that safety concerns about using labels are justified?
Falkenstein_ No. Security labels were approved as an anti-tampering device according to the EN 16679. Only safety labels with special material properties, which are irreversibly damaged upon manipulations, are used for serialisation. The Commission recommends this tamper-evident function in its Q&As, so it seems to be regarded as safe.

EuroBiotech_ What would you recommend in the current situation?
Falkenstein_ The situation has changed in a very positive way, since pre-serialized labels are officially released for all use cases for the German market now. Furthermore, all other EU-markets should go ahead with pre-serialized label where technically necessary, as the Commission said. Basically, the focus should be on the obligation to serialise. In other words, the pragmatic and risk-based approach should be chosen to ensure that products can continue to be market, if necessary with a pre-serialised label. At the same time, we should wait and see how further authorities will finally decide on this.

First published in European Biotechnology, Winter Edition 2018