"Serialisation not only means preventing counterfeit drugs - it also improves processes and saves costs."

From banknotes to passports: for over 50 years now customers from security sectors have trusted in the expertise of Atlantic Zeiser GmbH. This technology company is specialised in personalisation, customisation as well as Track & Trace solutions and is divided into three strategic business fields: “Banknote & Security Printing”, “Card Systems” and “Packaging”. The portfolio of this expert in coding technology also includes systems for counterfeit protection in the pharmaceutical sector. This issue is becoming ever more important because since the start of 2016 the Delegated Act (EU) 2016/161 has entered into force in the European Union. This Falsified Medicines Directive requires all packaging in the pharmaceutical sector in the EU to bear an individual serial number by 2019. This obliges packaging service providers for the pharmaceutical sector to implement measures for the serialisation of medicine packaging within 3 years so that companies, wholesalers and pharmacies can quickly identify counterfeit medicines.

Helmut Schneider is Product Group Manager for Pharma & Packaging Solutions at Atlantic Zeiser and explains in an interview how packaging manufacturers can create the necessary structures for the authentification of medicines and what these structures might look like.

Mr Schneider, with the Falsified Medicines Directive the EU wishes to curb the increasing trade in counterfeit drugs. Since when has it been possible to deploy serialisation for this purpose?

Serialisation for recognition and counterfeit protection has been used for a long time, for instance with banknotes and credit cards. The foundation stone here was laid by Italy in 2008 with pre-serialised labels in security print shops. In turn in 2010 Turkey was the first country to make the serialisation of medicines obligatory.

What consequences does the Falsified Medicines Directive have on the packaging of medicines?

Manufacturers of medicines cannot be viewed as a homogeneous group because the hazard potential is not the same for all pharmaceuticals and efforts for process improvements, for instance for returns, are therefore not evenly spread. In this case a space must be made available on the secondary packaging for code marking and the plain text. Pharmacists should use these changes to packaging material approval now necessary in order to achieve logistical simplifications and thus cost savings. For this the country-specific information should preferably be concentrated on one side of the folding box.

How many packaging service providers are already geared up for serialisation in the EU today?

I would say the number of packaging service providers already equipped is still under 10%. When we relate this figure to the number of actual packaging lines it is even lower because it is rare that all packaging lines are equipped by one manufacturer.

How can pharmaceuticals manufacturers and packaging service providers manage to meet the regulations for serialisation by 2019 and issue globally unique serial numbers?

The launch of serialisation is a major and far-reaching task for all pharmaceutical packaging operations. With regard to unique serial numbers the question is whether these should be generated centrally or decentrally. Initially, the serial numbers are created in a database according to a selected algorithm and these numbers are then distributed from the central point to the production locations and from there on to the individual packaging lines. With decentralised generation of the serial numbers each location and each packaging line is given unique, alphanumerical coding which is then channelled into the serial numbers algorithmically. This means unique serial numbers can be achieved even when they are issued decentrally.

How can pharmaceuticals manufacturers and packaging service providers manage to meet the regulations for serialisation by 2019 and issue globally unique serial numbers?

The launch of serialisation is a major and far-reaching task for all pharmaceutical packaging operations. With regard to unique serial numbers the question is whether these should be generated centrally or decentrally. Initially, the serial numbers are created in a database according to a selected algorithm and these numbers are then distributed from the central point to the production locations and from there on to the individual packaging lines. With decentralised generation of the serial numbers each location and each packaging line is given unique, alphanumerical coding which is then channelled into the serial numbers algorithmically. This means unique serial numbers can be achieved even when they are issued decentrally.

How long does it take to retrofit packaging lines in line with serialisation requirements?

Technical retrofitting can be achieved within a few weeks. For an initial pilot line the entire timeline can easily take two years as it may, under some circumstances, be necessary to redesign the packaging and make changes to packaging material approval.

What happens if the relevant guideline changes or if there are new regulations?

Can existing serialisation systems react efficiently? Indeed, it pays off for pharmaceutical companies to look to a manufacturer that has programmed the database application generically. In this case operators can themselves define the structure of the codes with the number and type of data fields. This makes it possible to carry out adjustments using parameterisation instead of programming and thus the manufacturer having to replace entire software packages. Replacement of entire software packages generally not only entails the qualification and validation of the new product but also the revalidation of all functions already previously in use which could be affected. In our serialisation software MEDTRACKER all principles that are already in force or are expected, are already implemented and can be adapted to the country-specific regulation or specificities with little expense/effort. Thanks to the modular system architecture the expense/effort of validation remains reasonable with smaller, subsequent adjustments.

It is possible that the information to feature on the packaging might change from time to time. Late Stage Customisation is the solution here. Can you explain the term?

It is not to be expected that the Delegated Act (EU) 2016/161, i.e. the data fields and type of the coding, will change. It is much more the case that the countries might occasionally change coding regulations, be this in terms of text changes, new requirements or changes to prescribed symbols. The term Late Stage Customisation relates to printing the packaging as close as possible to the delivery date, generally with the aim of being able to realise small batches, for instance country-specific packaging, as cheaply as possible. Printing is carried out using a digital process that, amongst others, can also perform serialisation. Another very positive side effect: this philosophy makes it possible to react very quickly and effectively to altered labelling regulations. Stock levels do not need to be reprocessed because these are generic and country-neutral in any case. The pre-requisite for this rationalisation benefit is the already mentioned generation of generic packaging that ideally contains all country-specific data on the side of the box.

What other challenges for packaging in the pharmaceutical sector exist beyond serialisation and Late Stage Customisation?

Smaller batches, for instance due to ever more specialised medicines for smaller target groups through to patient-specific medicine represent challenges. The drive towards cost saving in internal supply logistics, warehousing and distribution must not be neglected here.

What do packaging processes in the pharmaceutical sector look like today and what changes are anticipated in future? For instance, will it be possible to mark individual dosing instructions tailored to the patient thanks to serialisation and Late Stage Customisation?

With a consistent approach to Late Stage Customisation even batch sizes of 1, i.e. packaging bearing the name or ID number of a patient or patient-specific directions for use, are already feasible today. It can be anticipated that the instruction leaflet will be supplemented by a QR code with a link to the pharmacist or further product information. To predict far into the future a QR code on the packaging could replace the instruction leaflet and the information could be made available to the patient in multiple languages as text or a sound file. In particular for non-prescription products this would provide options for additional interaction with the patient.