However, Serialisation and the systems required to carry it out present significant business benefits, past achieving compliance.
What is involved in Serialisation and the EU-FMD?
To recap, EU directive 2011/62/EU or 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 09 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 if the lowest saleable unit.
First and foremost, anti-counterfeiting regulations protect patient safety by preventing falsified prescription medicines from reaching the market place.
In addition, compliance with these regulations provides additional benefits to the pharmaceutical industry.
- Consumer confidence
The primary concern in the case of counterfeit medicine is the risk that a patient will be exposed to and consume medicine that is potentially lethal or ineffective in treating their conditions, resulting in a worsening of symptoms.
Anti-counterfeiting technologies allow patients to retain trust in the brands they are accustomed to consuming, safe in the knowledge that they are receiving the best possible prescription drugs to treat their conditions.
- Brand Protection
When pharmaceutical manufacturers are confident their packaging sites and partners are compliant with regulations around Track & Trace, they protect the brand and values for which the company stands.
- Defend market integrity
Do you know the value of the global counterfeit medicines market? It surpasses that of most illegal substances.
Revenue lost through the sale of counterfeit product is revenue taken from treatment innovation, medicine research and new treatment development.
The additional information generated and recorded by Track & Trace systems presents multiple opportunities for yield optimisation as well as visibility and control of product across the supply chain, including potential recall processing that is unrelated to counterfeiting.
The day-to-day realities of a modern pharmaceutical supply chain present significant issues if the intricacies of Serialisation activities are not thoroughly understood. Equally, getting to know the full potential of the technologies and processes that are now fundamental to your operations will open up opportunities to improve business processes, defend your market position, improve supply chain efficiencies and establish your organization as an innovative market leader.
Grow your knowledge and contact experts of Track & Trace technologies to find out exactly what you need to know ahead of the February 2019 deadline.
The team in Crest Solutions is ready to advise, offering expertise developed through partnering with over 100 pharmaceutical companies in Europe to achieve compliance in 2017.
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.
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