EFPIA seeks vendors for EU medicine verification system06-Apr-2012
The European Federation of
Pharmaceutical Industries & Associations (EFPIA) has laid out
its vision of how the system of safety features enshrined in the EU
Falsified Medicines Directive (FMD) might work in a call-for-tender
Unsurprisingly, the document sticks close to the model tested in a pilot scheme in Sweden in 2009 by EFPIA and its partners, which relied on placing 2D datamatrix codes bearing GS1-compliant codes onto packs, and verifying them in the pharmacy as they were being dispensed to patients.
The codes will include a randomised serial number, product number, batch number and expiry date, and scanning should allow pharmacists to identify fake medicines as well as genuine material that is recalled, expired or should not be dispensed for some other reason.
EFPIA's 'end-to-end' model - dubbed the European Medicines Verification System (EMVS) - differs from the electronic pedigree system envisaged under Californian law, and also from the RxTec system of lot-level traceability and item-level serialisation proposed by the Pharmaceutical Distribution Society Alliance last month.
The document also describes the data management infrastructure around the EMVS, including a series of national data repositories, linked via an EU hub, that will "serve as the verification platforms which pharmacies and other registered parties can use to check a product's authenticity" and will have to handle up to 10 billion individual pack entries per year.
The EMVS will be able to handle parallel distribution of medicines, as well as multi-country recalls, and a blueprint for the national system architecture will be made available for countries that do not currently have a national system in place at the moment.
Details of the tender are published in a request for information document which describes the main functionality of the system and includes a questionnaire for potential vendor companies. An information meeting for prospective providers is scheduled to be held on April 19 in Brussels, Belgium.
EFPIA's call for tender pre-empts the EU Delegated Acts process, which is intended to fill in some of the key details left out of the FMD, such as the precise nature of the 'safety features' that must be added to prescription drug packaging.
Those involved in the Delegated Acts will be paying close attention to the proposals, however, as EFPIA has successfully enlisted the aid and support of the other main stakeholders in the European pharmaceutical supply chain, including groups representing pharmacists (the PGEU), wholesalers (GIRP) and parallel distributors (EAEPC).
Other models vying for attention as European lawmakers deliberate over the detail of the FMD include the eTACT pilot developed by the European Directorate for the Quality of Medicines & Healthcare (EDQM) and Germany's securPharm stakeholder initiative.
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