Irish repository being developed in response to new EU requirements for safety features on medicines
The Irish Medicines Verification Organisation (IMVO) is a new organisation being established by 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 released to the EU market from February 2019. The inclusion of safety features on packaging (i.e. a unique identifier 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.
The Irish national repository of unique identifiers 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 Organisation (EMVO) which is a collaboration between industry, pharmacy and wholesaler stakeholders at European level.
IMVO is now launching a formal consultation on the setting up of the national repository in Ireland and the principles, conditions and governance arrangements by which IMVO is expected to operate. Full details of the consultation, including details of how to submit feedback and further information on IMVO and the proposed repository, are available from the website of the Irish Pharmaceutical Healthcare Association.
The IMVO deadline for receipt of comments is 5.00 p.m. on Thursday 11 August 2016.