Industry news

EU FMD Safety Features

It has been reported this week that the European Commission has completed its impact assessment and is proceeding to draft a delegated Regulation to propose the following:

1. That the composition, format and carrier of the unique identifier will be fully harmonised across the EU. The unique identifier will be placed in a 2D barcode and contain the manufacturer code, a serialisation number, a national reimbursement number (if present), the batch number and the expiry date.

2. Medicine authenticity will be guaranteed by an end-to-end verification system supplemented by risk-based verifications by wholesale distributors. Medicines will be systematically verified before being dispensed to patients. Medicines at higher risk of falsification (returns or medicines not being distributed directly by manufacturers) will be additionally checked at wholesaler level.

3. The repository containing the unique identifiers will be set up and managed by stakeholders; i.e. the ‘European Stakeholder Model’ (ESM). National competent authorities will be able to access and supervise the database.

This delegated Regulation will first be published as a draft and the final version is not expected to be adopted by the Commission until the end of 2014, at the earliest. Publication in the Official Journal will then follow in 2015 after successful scrutiny by EP, Council and WTO.

NOTE: The ESM is the product of collaboration between the pharmaceutical industry (EFPIA), wholesalers (GIRP) and pharmacists (PGEU). This is based on a 2D bar code with a unique serial number and is designed around a central hub that will be linked to national or regional databases that pharmacists and others can use to check the authenticity of packs. The system was successfully trialled in Stockholm, Sweden, in 2009/10. The ESM system will be managed by a not-for-profit stakeholder organisation.