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Falsified Medicines Directive

Countdown to Falsified Medicines Directive is happening, On Saturday 9 February 2019, the Falsified Medicines Directive (FMD) will go live across Europe. On that date, the entire pharmacy sector will be expected to adhere to FMD — formally known as Directive 2011/62/EU of the European Parliament and of the Council — which aims to prevent falsified medicines entering the formal pharmaceutical supply chain and ending up in the hands of patients. FMD applies only to prescription medicines: with the single exception of omeprazole, which was once found to be falsified, over-the-counter medicines are not subject to FMD rules.

The Delegated Regulation (EU2016/161) from the European Parliament and Council supplements the Falsified Medicines Directive (FMD) and introduced two mandatory safety features that will allow medicines to be verified and authenticated.

Marketing authorisation holders are required to place safety features on the packaging of all medicines which fall within the remit of this regulation by 9 February 2019.

What does this mean for my business?

The two mandatory safety features are:

A unique identifier must be placed on medical products that can be scanned at fixed points along the supply chain

The unique identifier:

Must be applied to every pack of medicine at point of manufacture by the marketing authorisation holder

Must be coded into a 2D data matrix – sometimes known as a 2D barcode – and also as human readable information

Must relate to the product type and other specific information such as batch number and expiry date

Must be uploaded to a data repository by the marketing authorisation holder (this includes distributors who repackage goods)

This unique number – the product type, batch number and expiry date – can be verified and authenticated at any point in the supply chain, for example, by scanning it using a barcode reader

Before the medicine is dispensed, the pharmacy or hospital must verify the authenticity of a medicine by checking it against the data repository

There must be an anti-tampering device (a security seal) on the pack

Benefits and opportunities

Whether you’re a pharmaceutical manufacturer, distributer, or pharmacy, there are significant benefits to your business in uniquely identifying product information, and then capturing and sharing this along its pathway – and eventually to the patient.


These benefits go beyond simply meeting regulatory compliance with the Falsified Medicines Directive. There are the benefits and cost savings in operational efficiencies and – ultimately – patient safety. Think about being able to automatically validate expiry dates. Or even track and locate safety recalls right down to the individual batch number and which patient it has been given to.

For further information on the products and services we can help you achieve compliancy contact sales@bcdata.co.uk alternatively call 03333 660 842

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