Falsified medicines directive – it is now or never for pharmaceutical companies

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Omron Industrial Automation is a leading manufacturer of technologically advanced industrial automation products and application expertise.

EFPIA’s Christoph Krähenbühl provides an overview of the requirements of the legislation, how these will impact on companies and what it means in practical terms

The third report from the seminars at the Total Processing & Packaging Exhibition  


Christoph started by outlining the growing and substantial threat of falsified medicines penetrating the European pharmaceutical supply chain and that adoption of EU Falsified Medicines Directive (FMD) in EU member states is an important step in protecting patients from counterfeit medicines.

European pharmaceutical supply chain actors are developing a system that will meet requirements of the FMD by providing a high level of safety for patients, be cost-effective and integrate effectively into existing supply chain processes.

European Stakeholder Model (ESM)

The ESM is a European end-to-end system enabling medicines to be verified at point of dispensing to the patient. It has been developed by the stakeholders who will use it in day-to-day operations. The ESM ensures safe access to medicines, is a cost-efficient and interoperable solution, is run on a non-profit basis, is transparent and partnership-based. The *ESM partners – EAEPC, EFPIA, GIRP, PGEU – have joined forces to provide the best solution for patients.

What are Falsified Medicines?

Fake medicines may contain low quality ingredients or the wrong doses, have their identity or source deliberately mislabelled, have fake packaging or the wrong ingredients. They pose growing threat to public health and safety in Europe and there has been a steady increase in number of counterfeit medicines.

The 2011 EU Falsified Medicines Directive defines measures to increase reliability of the medicinal supply chain manufacturers to apply safety features to allow verification of authenticity and identification of individual packs. Repository systems must be established to house information on safety features. Costs for repository system will be borne by Manufacturing Authorisation Holders (MAHs). ESM partners want to deliver an effective system on time and mandatory compliance to FMD expected in 2017.

EU FMD – Delegated Act

The Delegated Act will decide characteristics and technical specifications of the unique identifier, extent and modalities of verification of the safety features to ensure verification of authenticity of each dispensed pack, criteria for the risk assessments and process for notification of products included and establishment (including accessibility) of the repositories.

Christoph pointed out that although it is impossible to know the content of the Delegated Act, a European Commission Consultation carried out in November 2011 to April 2012 showed it is likely to cover emerging alignment on harmonisation through regulation, International standards, 2D barcode with 4-data elements, inclusion of national numbers where necessary at national level, mandatory point-of-dispensing check with optional random verification by wholesalers.

The exact outcome of the Delegated Act (due in 2014) is not yet apparent, but there are clear indications of the direction and participation in a systems-based Europe-wide Medicines Verification process is a given.

ESM uses 2D data matrix codes, developed to internationally recognised standards. The four key data elements are Manufacturer Product Code, Randomised Unique Serial Number, Expiry Date and Batch Number.

ESM proposes stakeholder-driven governance organisations. Members are set to include manufacturers, pharmacists, wholesalers, parallel importers and be represented by European Associations.

The main theme of Christoph’s seminar was that the time available for manufacturers to ensure they are fully prepared for the EU FDM is fast running out. Although the minute details have not been finalised, the direction and shape of the post-2017 pharmaceutical supply chain in Europe is largely clear. If these are not acted upon, there is a real danger that some pharmaceutical companies will not be able to trade in Europe after 2017.


The only way to read and verify the four key data elements will be via machine vision. Omron produces a wide range of pharmaceutical vision inspection systems and although the detail of the Delegated Act is unknown, its flexible technology platform offers the flexibility to adapt to changing market requirements.

The company’s Xpectia machine vision systems offer a wide range of solutions including printed text inspection and barcode verification, and label, blisterpack, defect and vial inspection. They are the ideal choice for pharmaceutical companies looking for cost effective automated inspection solutions, with additional software functionality, allowing the system to be validated to the CFR 21 pt 11 standard.


*European Association of Euro-pharmaceutical Companies (EAEPC)

European Federation of Pharmaceutical Industries and Associations (EFPIA)

European Association of Pharmaceutical Full-line Wholesalers (GIRP)

Pharmaceutical Group of the European Union (PGEU)

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Omron Europe

Omron Industrial Automation is a leading manufacturer of technologically advanced industrial automation products and application expertise. From its European headquarters in Hoofddorp, near Amsterdam in the Netherlands, she operates locally in every European country and is dedicated to providing unrivaled automation products and customized expert solutions for any industry.

The product portfolio includes state of the art Factory Automation services & Know-How, Sensors and Safety, Mechatronics and Drives, Industrial Components and Vision Systems.