Be ready for EU packaging safety regulations


Are pharma companies ahead of the curve or dangerously behind in their implementation strategies for compliance with the forthcoming EU Safety Features regulations in the EU's Falsified Medicines Directive (FMD)?

In 2018, patients will see a fundamental change to the European healthcare supply chain: every time a pack of medicines is dispensed, its bar code will be scanned in the pharmacy and a series of automatic checks will be carried out - all within a fraction of a second - against a Europe-wide medicines verification infrastructure of systems.

This pack identification code, in the shape of a 2D DataMatrix code and similar in appearance to a QR code, will be globally unique. It will contain the product code (and possibly national healthcare reimbursement number), the batch/lot number, the expiry date and a randomised serial number.

The scan will give the dispensing pharmacists instant feedback about the status of the product under the stated aims of the European Falsified Medicines Directive (FMD), 2011/62/EU 'Safety Features' provisions. It will enable them to see whether the pack number has been dispensed before and could therefore be a counterfeit product; they can ensure it is still within its expiration date and check whether there is a recall or other notice against the batch.

"Implementing this unique pack coding system presents a huge step forward in terms of patient safety"

Implementing this unique pack coding system presents a huge step forward in terms of patient safety. However, it will also require a tremendous amount of work - not simply in terms of the development and deployment of the complex Europe-wide systems infrastructure, but also in terms of pharmaceutical manufacturers' implementation schemes to be ready for compliance. This affects those supplying the 28 EU member countries, including original brand owners, generics manufacturers, contract packers or repackagers/parallel importers.

While big pharma companies such as AstraZeneca, Novartis and GlaxoSmithKline have all started their implementation programmes - many of them driven by earlier similar compliance requirements in Turkey, China, Argentina and South Korea, to name but a few – others are still not acting.

Action needed

According to Thomas Brückner, head of Pharmaceutical Affairs/ GMP/ Medicinal Products/ CAM/ Pharmacopoeial Matters at the BPI , Germany's Federal Association of the Pharmaceutical Industry, "Only companies that are already engaging with the technical and organisational challenges associated with the implementation of their EU-FMD response have a realistic chance to be ready at the point of time when the EU-FDM 'Safety Features' Delegated Act comes into force, to continue their supply of the market with product that is packaged in line with the requirements of this legislation."

Brückner is also on the management team for the SecurPharm pilot, a German national system that started on 1 January 2013 and that operates along similar lines to the Europe-wide system currently in development. It has been gradually increasing operations in the German healthcare supply chain, providing over 10 million item-level serialised packs to over 400 participating pharmacies across Germany, even though participation in the system is entirely voluntary.

Practical participation

Practical participation in the system has revealed what challenges exist at every step, from generating, printing, reading and storing the unique pack identifiers to the preparation of the artwork and packaging materials, as well as cleaning up the master data and setting up new business processes.

All of this is in addition to the implementation of a complex and expensive serialisation technology stack starting from the packing lines to the site management console and the company-wide secure numbers repository.

However, companies taking part in the SecurPharm initiative will find the transition to full participation in the post-2018 Europe-wide EU-FMD medicines verification landscape relatively painless.

So why are companies in many countries - notably the UK - failing to engage with these requirements? One argument is that there is a lack of clarity, as the details will not be defined until publication of the 'Safety Features' Delegated Act, which is expected later this year. However, even when the legislation was first published in 2011, it included a clear projection of what the safety features part of the EU-FMD would entail.

Clear vision

The directive mentions 'unique identifiers', 'authenticity of medicinal products to be verified', 'individual packs to be identified' and 'provisions on the establishment, management and accessibility of the repositories system in which information on the safety features, enabling the verification of the authenticity and identification of medicinal products... shall be contained', all of which present a clear vision of a Europe-wide medicines verification process.

This vision, with the key element of a mandatory point-of-dispense check, supported by a set of interoperable systems, has been confirmed and refined since 2011 through consultation processes and stakeholder updates.

The European Commission stated, via the EU Europe Direct information service: 'The Commission aims at adopting the Delegated Act by the end of 2014. Publication in the OJ [Official Journal of the European Union] will follow in the first half of 2015, due to Parliament, Council and WTO scrutiny rights."

This means that the Delegated Act will apply from the first half of 2018 and will set the three-year compliance implementation clock ticking for almost all member states (apart from Italy, Belgium and Greece, where it could be argued that existing vignettes and bollini provide a unique identifier, buying these markets an additional six years to implementation).

"Starkly, manufacturers whose packs do not carry the unique identifiers will no longer be able to sell their products in Europe"


Starkly, manufacturers whose packs do not carry the unique identifiers will no longer be able to sell their products in Europe. Companies that have not yet started their implementation programme and may not have budgeted for implementation activity in 2015, are running the risk that they will be losing their European sales from 2018.

Even companies which have started on their programme but not yet engaged with technology stack solution providers are facing serious challenges: from speaking to vendors, it is clear that they are facing rising numbers of orders and their lead-times are already increasing.

Add to that the realistic estimate of a best-case implementation timeline for the first pilot line to repository installation taking at least 18 months, and it becomes obvious that the task of implementing the serialisation capability and operating it reliably and without a significant hit on productivity across the majority of a company's packing lines will take several years.

It could be argued that concerns about pharma companies' readiness might be serious enough to ask whether they will remain viable in the market beyond the 2018 EU-FMD 'Safety Features' compliance date.


About the author:

Christoph Krähenbühl is a respected serialisation expert and thought leader in coding and serialisation for the pharmaceutical industry. Along with partner Ian Haynes, he runs 3C Integrity, a specialist consulting firm which runs two-day training programmes to prepare pharma companies for implementation.

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Have your say: What are your thoughts on the upcoming safety regulations?

Linda Banks

3 September, 2014