EU Falsified Medicines Directive 2018

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The World Health Organization (WHO) estimates that up to 1% of medicines available in the developed world are likely to be counterfeit and when applied globally this figure increases to 10%. With many of the medicines used in the UK manufactured overseas, this multi billion pound marketplace is attractive to those who would exploit and sell dangerous and counterfeit products into the supply chain.

The  EU Falsified Medicines directive was first proposed in December 2008 and approved by February 2011. It aims to prevent counterfeit or falsified medicines entering the supply chain and reaching patients by strengthening all aspects of the manufacture and supply chain across Europe.

Each individual pack of prescription-only-medicine (POM) will require a unique identifier (which will most likely be through the use of a 2D Datamatrix barcode utilising serial numbers and item expiry dates) to be displayed on all product packaging, down to the smallest sale-able unit of drugs to enable it to be authenticated and verified.

For those businesses supplying the industry and still using a paper based warehousing system, with the final part of the EU falsified Medicines Directive coming into place in 2018 and with the regulatory information typically being encoded into 2D barcodes it will surely become increasingly challenging for businesses to manage their products using these traditional methods. 

Who is affected ?

• Supply chain stakeholders
• Branded manufacturers
• Wholesalers
• Parallel traders
• Pharmacies

 What needs to be done?

• At the point of manufacture a unique identifier must be applied to every pack of medicine
• This unique identifier must relate to the type of product but also contain information such as batch number and expiry date
• The unique identified must be recorded on a data repository by the manufacturer
•  Before a medicine is dispensed, the pharmacy or hospital must verify the authenticity of the medicine by checking it against the data repository
• Aside from compliance being regulatory by 2018, automating  traceability will streamline business processes.

If you have other questions we recommend contacting GS1 who are offering introductory webinars to explain the background to the healthcare regulations and the relevant GS1 standards that will help you comply with this directive.

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