Are You Familiar With The Falsified Medicines Directive?

Manufacturers of medication making use of pharmaceutical repackaging companies might find it beneficial to familiarise themselves with the Falsified Medicines Directive (FMD), which came into force in February of this year.

This is legislation that was passed by the European Union Parliament, put together to increase the security of both the manufacturing and delivery of medicine throughout Europe to better protect people and prevent fake medication from entering the supply chain.

The regulations mean that manufacturers have to ensure that safety features are placed on all medicines, as well as making financial contributions to the setting-up of an IT verification system that will permit the assessment of medicine authenticity at the time of supply to the patient.

Despite the fact that unlicensed internet sites are now the main way that falsified medication is traded to members of the general public, authorities are still finding and reporting such medicines in the supply chain. Not only do these pose unacceptable risks to people, it undermines confidence in genuine products.

What are falsified medicines?

These are medicines that contain little or no active ingredients, fake or tampered packaging, incorrect active ingredients or medication where the products or packaging have been stolen for either reuse or resale.

As of last month (February), all new packs of prescription medication entering the market throughout Europe will need to have two safety features included – a unique identifier in the form of a barcode and an anti-tamper device.

This idea is still being considered here in the UK and wholesalers are able to decommission products for healthcare professionals, public service bodies and others that use or supply medication as occasional parts of their work. Community and hospital pharmacies, however, are specifically excluded from this.

Writing for Health Europa, global head of marketing at Origin Rich Quelch explained that because of Brexit there are doubts over how UK organisations will be affected by the legislation.

If a long-term deal with the EU is secured, there will be little difference – if any – for the foreseeable future, with businesses expected to use the new regulations like any member state would do.

However, a no-deal exit scenario would mean that our supply chain would be under no obligation to follow the terms of this directive. UK companies would also be left without access to the EU central database, unable to store or upload product data, and they’d be faced with the same risks they’re currently looking at where fraudulent products are concerned.

The Association of the British Pharmaceutical Industry and the BioIndustry Association have both issued warnings that a no-deal exit would mean the UK is a big target for fraudulent products in the future, as well as suggesting that businesses should be refunded for both the time and money that they’ve already sunk into implementing the FMD.