What is FMD?

The Falsified Medicines Directive is European Union legislation designed specifically to stop the supply and subsequent sale of any falsified medicinal product.

Applicable to 32 different countries, it legislates all relevant businesses within the medicinal supply chain to record all verifications and disposals to the national hubs, and ultimately the European hub, where the medicinal products will be cross-referenced against manufacturer records held.

All manufacturers, wholesalers, importers and exporters, re-packers, dispensaries (including hospitals and GP surgeries) and any other persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy, must be able to directly or indirectly demonstrate compliance by 9th February 2019. Businesses will also need to have a process in place to ensure they record the pack information for all packs in their possession and demonstrate the verification, dispense or disposal of the same packs when they are distributed onwards in the supply chain. As with any verification, dispense or disposal process, records must be kept for audit and compliance demonstration purposes.

What are the impacts of FMD?

The FMD will introduce another set of systems and processes into your business. As the FMD relies on the electronic communication of medicinal pack information to and from the national and European hubs at all points of the supply chain, all businesses requiring compliance must have access to a system capable of collecting and sending this information, as well as receiving and storing the validated approval messages from the hubs. Businesses will also need to have a process in place to ensure they record the pack information for all packs in their possession and demonstrate the verification, dispense or disposal of the same packs when they are distributed onwards in the supply chain. As with any verification, dispense or disposal process, records must be kept for audit and compliance demonstration purposes.

What do you need to do?

Firstly, you must confirm if the FMD applies to you. If it does, you will need to source a suitable system to track and report your inbound and outbound medicinal product movements, as well as storing the confirmation messages from the national and European hubs. If you fall under Article 23, then please contact us, and we will connect you to your nearest FMD compliant partner.

Secondly, you must also educate your employees and colleagues about the FMD and ensure that you and they keep your business compliant with the directive and its stipulations. This will include ensuring you can demonstrate every medicinal product in your possession is legitimate and you can 100% demonstrate the onward sale or disposal of those packs.

The FMD ensures integrity at every stage of the supply chain, which requires you to be in control of your part in that chain and that you can verify the source of your medicinal products and their onward destination or purpose.

But, don’t worry, please contact us to discuss your needs. FMVerify can help. Businesses will also need to have a process in place to ensure they record the pack information for all packs in their possession and demonstrate the verification, dispense or disposal of the same packs when they are distributed onwards in the supply chain. As with any verification, dispense or disposal process, records must be kept for audit and compliance demonstration purposes.

How can FMVerify help?

FMVerify is an inexpensive, fully FMD compliant solution, supported by a team of professionals from the IT and Pharmaceutical industries. We can answer all your questions and help advise whether FMVerify is right for you and your business.

We will demonstrate our product at no charge and talk through your business needs and processes. If suitable, we will offer you a free trial to test our product and will assist you in designing or amending your processes to integrate FMVerify with your business efficiently, optimally and with minimum disruption.

Should you wish to proceed, FMVerify would be happy to provide you with your FMD compliancy solution and support you in not only in becoming FMD compliant, but staying FMD compliant. This will include giving you access to standard and enhanced reports for compliance and stock management.

We are confident the FMVerify solution is the right one for your business.

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About FMVerify

FMVerify is a purpose-built FMD compliant solution, specifically designed by professionals in the medical supply chain industry.

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