Ireland to consult on setting up of IMVO & national repository of unique identifiers

The Irish Medicines Verification Organization (IMVO) is a new organization being established by a range of stakeholders across the medicines supply chain in Ireland to set up and manage a national repository of the unique identifiers that will be included on the packaging of most medicines placed on the market from February 2019.

The inclusion of unique identifiers on packaging (in the form of product data embedded in a 2D barcode) and an anti-tamper device are mandated by the EU Falsified Medicines Directive 2011/62/EU as part of a suite of measures to reduce the risk of falsified medicines entering the EU supply chain. These safety features will facilitate the checking of the identity and authenticity of medicinal products as they pass through the legitimate supply chain and prior to being supplied to patients. The detailed requirements for safety features and the repository systems for unique identifiers across Europe are set out in Commission Delegated Regulation (EU) 2016/161 (Delegated Regulation) which supplements the Falsified Medicines Directive.

The Irish national repository and similar repositories across Europe will be linked through a ‘European Hub’ to form the European Medicines Verification System (EMVS), which is a pan-European system to identify and authenticate medicinal products wherever they are located in Europe. The EMVS is being overseen by the European Medicines Verification Organization (EMVO) which is a collaboration between industry, pharmacy and wholesaler stakeholders at European level.