Limerick, July 4, 2018 — OPTEL is proud to announce that it is now officially connected to the Irish Medicines Verification Organization (IMVO), part of the European Medicines Verification System (EMVS). OPTEL has obtained the Single Pack transaction self-certification, demonstrating the complete connectivity to the IMVO and approval of the single pack functionality following multiple test cases.
The European Hub
With regards to the Delegated Regulation (EU) 2016/161, the European Commission stated that repository systems must include a central information and data router (the European Hub) and repositories connected to the EU-Hub. Therefore, each European country has to implement a National Medicines Verification System (NMVS) which will be set up and managed by a National Medicines Verification Organization (NMVO).
The EU FMD
The EU FMD requires that all medicine packs carry a barcode containing unique identifiers, so they can be verified and authenticated when going through the medicines supply chain and then dispensed to patients. All the unique identifier information is stored in a national database, a repository – such as the IMVO for Ireland.
Compliance Projects with OPTEL
OPTEL will be collaborating with early-adopter commercial and hospital pharmacies preparing for the EU FMD deadline. In conjunction with the Irish Pharmacy Union (IPU) located in Ireland, these industry stakeholders will initiate their implementation of OPTEL’s decommissioning solution for EU FMD compliance – OPTEL CERTA™. OPTEL will begin testing the IMVO systems in July, performing the verification and decommissioning of 2D barcode-labelled medicines. OPTEL CERTA™ will connect directly to the IMVO, allowing pharmacists to familiarize themselves with this new decommissioning practice, to ultimately integrate it into their workflow.
In addition to the IMVO connection through Solid Soft, OPTEL is pleased to state that it is now confirmed as a preferred supplier for the following NMVSs through the Arvato system: UK, France, Norway, Spain, Netherlands and Belgium/Luxembourg.
Ensuring the safety of patients is at the heart of OPTEL’s operations, as the company provides leading traceability solutions to the healthcare industry. This certification certainly reflects OPTEL’s efforts to optimize the compliance process for its customers as well as ensure pharmacovigilance in this sector.
IMVO is a not-for-profit organization that has been established by a range of stakeholders across the medicines supply chain in Ireland (pharmaceutical manufacturers, parallel distributors, wholesalers and community pharmacists) to set up and manage the Irish medicines verification system. The establishment of IMVO is mandated by EU law. Specifically, the Falsified Medicines Directive (Directive 2011/62/EU) introduced a requirement for all medicine packs to carry a special barcode containing unique identifiers. These will enable the pack to be verified and authenticated as it passes through the medicines supply chain and before it is dispensed to a patient. Details of the unique identifiers from each pack will be stored in a national database (‘repository’). Pharmaceutical manufacturers and marketing authorisation holders are obliged to set up and fund a not-for-profit legal entity to manage each national repository. IMVO is the relevant organization in Ireland. It was incorporated as a company limited by guarantee in April 2017.