Both Falsified Medicines Directive (FMD) and Brexit contribute to the increased risk of medicines shortages. The safety measure of falsified medicines directive’s regulation means that after the implementation period, all the medicines packs should be scanned at the time of dispensing in order to protect patients against the expired, falsified, and recalled or FMD Brexit now the IT infrastructures are linked which allows the checks to be made. The Brexit uncertainty leads in helping, designing, building and providing protection against the fake medicines as well as it safeguards the system.
Safety Measures Prevents Entry of Falsified Medicines in the Supply Chain
• Anti- Tampering Device (ATD): The anti-tampering devices are also one of the most important safety measures used for the prevention of falsified medicines.
• Unique Identifier (UI): The unique identifier is in the form of 2D (data matrix barcode) is one of the best preventive or safety measures from entering of Fmd Falsified Medicines Directive entering the legitimate medicines supply chain. The unique identifier consists of
*Serial Number
*Product Code
*Batch Number
*Expiry Date
*National Reimbursement Number
The falsified medicines are those which are having little or no active ingredients or wrong active ingredients having fake or the tampered packaging. The unlicensed internet sites have now become the main route for the trading of falsified medicines to public whereas the regulatory authorities finds and reports the falsified medicines in the supply chain. Thus such falsified products poses high risk to patients as well as trust and confidence also reduces in using these products. But to prevent all these illegal falsified supply of medicines, all the new packs of the prescription under the directives are placed on the market from 9th February 2019 and two safety measures are added to it.
Implementation of FMD
The FMD will be introduced in 32 countries with the inclusion of scanning and authentication of packs. It follows the publication of delegated regulation which fixes the details and set it such as unique identifiers, national verification systems and the responsibilities of wholesalers, manufacturers and pharmacies. It promotes harmonization as well as it reduces the costs.
Both Falsified Medicines Directive (FMD) and Brexit contribute to the increased risk of medicines shortages.