With EDQM Absent, EFPIA Launching Own Anti-Counterfeit Strategy
Posted 03 May 2012 | By
The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced it has signed on to a Memorandum of Understanding (MoU) that it says will help to set up a harmonized system of international standards to prevent counterfeit products from entering or proliferating within the pharmaceutical supply chain.
EFPIA said the MoU, reportedly developed jointly between groups representing pharmacists, wholesalers and distributors, adopts what is known at the European Stakeholder Model (ESM).
The ESM model "involves having a series of national data repositories in EU Member States that pharmacies could use to verify product information," writes PM Live.
"These would be linked via a European hub and involve standardized systems to detect counterfeit products, forming what EFPIA describes as the European Medicines Verification System (EMVS)," explains PM Live. "The European hub would be run by the European Medicines Verification Organization (EMVO), which would provide a centralized location for the storage of product master data and a central point from which product recall actions can be initiated."
EFPIA noted in a statement it believes the model has the potential to automate expiry date checks, improve pharmacovigilance methods, reduce fraudulent reimbursement transactions and improve recalls and product returns.
Notably absent from the agreement, notes Securing Pharma, is the European Directorate for the Quality of Medicines and Healthcare (EDQM), which said in April that it would not be signing onto EFPIA's plan and would instead continue to develop its own anti-counterfeiting strategy.
EFPIA - EFPIA Board Moves to Next Phase in Setting Up a Cost-Effective System For Medicines Verification with Stakeholders
PM Live - EFPIA agrees Europe-wide plans to tackle counterfeit medicines
Securing Pharma - EFPIA reports progress with medicine verification scheme
Regulatory Focus - EDQM Continuing Development of New, Comprehensive Anti-Counterfeiting Strategy