On the 9th February 2019 all pharmaceutical businesses in Europe must exercise compliance with the Falsified Medicines Directive. Here’s a simple checklist to make sure you don’t get caught out.

EU FMD: Why you need to comply

The Falsified Medicines Directive has been implemented to protect patient safety and tackle counterfeit criminality that siphons hundreds of millions of pounds away from the pharmaceutical industry every year.

The upshot of the legislation is that all pharmaceutical medicines and products must carry a unique code – at the item level. And while adapting your production line for compliance presents initial operational challenges, early adopters have realised increased efficiency, reduced waste and enhanced control of products.

With the 9thFebruary deadline looming, there is an urgent need to make sure your item-level coding is compliant. Failure to comply could result in regulatory fines or the prohibition of sales across the European market. Follow the checklist below to ensure your codes are above board and legally watertight.

Code quality

ISO 15415 specifies eight parameters for overall code quality – or ‘grading’. Grades A to C will be acceptable to DG Sanco – the European Commission Directorate-general for Health and Consumers Protection – with all else rejected.

Code contrast

The contrast of your codes is critical to grade quality. They must be machine-readable. Our professional Domino sample labs in the UK, Germany and the USA have extensively tested numerous cardboard types to optimise grading and reduce rejection rates for a range of customers. You can view our laser report here and our TIJ report here.


Because most medicines have a three to five-year shelf life, lightfastness is a key concern given the requirement to scan not only at the point or product but at dispense. You must guarantee that your codes remain readable throughout the product lifecycle. If your code fades to the point of illegibility, medicines will likely be shipped back to you.


Machine readability

Your codes will be read by machines like scanners and cameras that are much less forgiving than the human eye. Codes that meet ISO/IEC 15415 will be machine readable. Track and Trace means machines exercise binary decision-making – readable or unreadable – at the supply chain’s every step. There is no room for error.

Ink dry time

Ink dry time is vital to prevent smudging of the necessary coding, particularly with products that demand tamper-proof packaging where the risk of smudging is enhanced.

Are you ready? We are, and we can help.

We have already ensured a number of our pharmaceutical clients are fully prepared for the rollout of the FMD legislation. We can do the same for you. If you would like face-to-face advice on your preparations, get in touch to arrange for one of our serialisation teams to visit your facilities.



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