It was important to mend and enforce strict laws to keep check over the circulation of falsified medicine, since there always had been a risk of supply of false medicine posing danger to patient’s health. So, European Union made a process to give authenticity to medicine that is EU FMD.
Before discussing further, there arises an important question what Falsified Medicines Directive and their risks are.
Falsified medicine are fake drugs often disguised as authentic and real, but they contain really poor quality or inappropriate strength of the active ingredient that is used in original medicine to give its effects. These are in wrong dosage, which are risky for health when consumed by the patient. They have not been evaluated properly for their quality, safety and efficacy.
European Union (EU) had taken strict measures against the global risk provoked by falsified medicines and securing their circulation in market. A catalogue had been made through European medicines verification organization (EMVO) for advancing the European medicine verification system (EMVS).
As a result, a directive 2011/62/EU known as falsified medicine directive (FMD) came into effect to prevent the entry of falsified medicine in legal chain and check its circulation.
Infiltration and circulation of Fmd Falsified Medicines Directive is major threat to patient health. This feature ensured implementation of functional, secure, and cost-effective medicine circulation across Europe and also regulated new rules to pharmaceutical companies.
Legal framework by EMVS: EU FMD has Safety feature that include a unique identifier (UI) which is a 2D data matrix (barcode) and an anti-tempering device (ATD) on the outer packaging of medicine.
This is to ensure the medicine safety and prevent them from tempering and duplication at each supply chain. The packaging remains intact and reaches as it is without any duplication from manufacturer to supplier and retailer and then to consumers. Since, it is a long process there are chances of tempering the unique ATD and barcode safety ensure there is no threat with the medicine. It also made strict quality check to omit false medicines that may have low or high strength of an active ingredient.
Pharmaceutical manufacturing companies, wholesalers, retailers across Europe use system based on shared database and tamper-proof packages with barcodes for this legal process by EU falsified medicine directive for quality control.
For this critical operation specially designed software, Epos is used to maintain all record. Epos system is widely used in UK pharmacies.