Achieving compliance with the EU Falsified Medicines Directive – what you need to know


As published in this months EPM....

Here, Dan Anslow, UK sales manager, shares some key tips and insights, learned through partnering with phamaceutical manufacturers  that have already successfully implemented solutions for serialisation, aggregation and Track & Trace.

Effective in Europe from February 2019, EU directive 2011/62/EU, also referred to as EU FMD, aims to reduce counterfeiting of prescription drugs by tracking and tracing the passage of drugs through the entire supply chain.

Under the Directive, all new packs of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a verifiable unique identifier (serialised code) and an anti-tamper device.

Serialisation is the process by which the pharmaceutical manufacturer, using country specific regulations and GS1 standards, must assign and apply a unique serial number (in both a 2D data matrix barcode and human readable form) to an individual item to be sold to a consumer, this product identifier is recorded on the outer packing.

As someone who has worked at the coal face of the design and implementation of Track & Trace system, I have seen first-hand the realities of achieving compliance with regulations including the FMD.  Below I have outlined some key tips and insights that I have learned when partnering with pharma manufacturers that have already successfuly implemented solutions for serialisation, aggregation and Track & Trace.

For those that are beginning or in the process of implementation, use the below guide to avoid common pitfalls and benefit from identified areas of good practice on your journey to compliance. 

Serialisation and the EU-FMD

  • To avoid both product contamination and product counterfeiting, many countries have introduced regulation, typically referred to as “Track and Trace” or “Serialisation” which protects the integrity of a bone fide pharmaceutical carton or bottle.
  • In the case of the European Falsified Medicines Directive, the regulation deadline is the 9th of February 2019.
  • The EU-FMD pertains specifically to the lowest saleable item of prescription medicine, which requires a unique reference number or “Serialisation Number” which is displayed as human readable text and embedded within a 2D matrix.
  • The carton or bottle must also must contain Anti-Tamper Evidence.
  • The unique codes will be transferred to the EMVO, commonly known as the European Hub, which will then transfer the codes to the relevant national hubs where the product will be sold.
  • At the end of the supply chain a pharmacist will scan the 2D bar code and in real time check with the National Hub that the code is bone fide before releasing to the patient.

The 3 components of a successful Serialisation implementation

There are 3 key components of Serialisation, and they might not be what you expect:

  • Stakeholder engagement
  • Vendor selection & relationship
  • Staff training

Things to watch out for

  • Ensure your team is on board from the very beginning. The relevant stakeholders and teams must have a clear understanding of the scale and impact of the project to be undertaken and what will be required of them.
  • When selecting a vendor, consider experience and their ability to support your site on the ground.
  • As regulations in this sector are evolving, technology can be immature and, with the best of intentions, vendors can over-promise. Ensure you complete due diligence and test the systems in any possible environment (demo or reference sites) for weaknesses throughout the development process.
  • Visits to reference sites where solutions have already been implemented are a must!
  • Your team of line operators will appreciate an understanding and training in this technology.

If you would like to know more get in touch

Crest Solutions partners with pharma clients in the UK, Ireland, Benelux and Scandinavia to deliver and support solutions for Serialisation and Aggregation from Antares Vision.

Read this article in EPM February issue

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