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.