New regulations present Irish Healthcare with a significant opportunity to improve patient safety and drive down costs

Jul 27, 2017, by Siobhain Duggan - Category: HSE host information day for industry and healthcare providers to explore challenges and benefits of product identification and tracking requirements

The opportunities and "unintended" benefits delivered by new EU and US healthcare regulationsRegulation is coming - the time to act is now. This was the key message from speakers at the Healthcare User Group (HUG) Information Day, hosted by the HSE at Cherry Orchard Hospital in Dublin. The event was attended by almost 100 delegates from across both hospitals and industry, including a significant delegation of pharmacists.EU and US Regulations and Directives: Falsified Medicines and Unique Device IdentificationThe Health...

IMVO formally established & blueprint provider selected for Ireland

Apr 18, 2017, by Siobhain Duggan - Category:

The Irish Medicines Verification Organisation (IMVO) has been formally established as a not-for-profit company limited by guarantee. This is an important step in the implementation of new EU requirements for safety features on medicines in Ireland which will provide Irish patients with reassurance against falsified medicines.The IMVO has been established through a collaboration between key players in the prescription medicines supply chain in Ireland. Its founder members include:Association of Irish Pharmaceutical Paral...

The EU Delegated Act has Landed

Feb 3, 2015, by  - Category: Serialisation expert Christoph Krähenbühl examines the latest update on the 'Safety Features' Delegated Act and gives his view on how some of the proposed provisions could have a significant impact on pharmaceutical manufacturers

Former AstraZeneca serialisation expert and member of the EFPIA-led European Stakeholder Model (ESM) technical experts working group, Christoph Krähenbühl, examines the latest update on the 'Safety Features' Delegated Act, currently being examined by Member States' expert teams and gives his personal view on how some of the proposed provisions could have a significant impact on all stakeholders, in particular pharmaceutical manufacturers supplying products to the European Market. European Falsified Medicines Delegated A...

Traceability of medicines and the falsified medicines directive (FMD) is your organisation ready?

Oct 16, 2014, by Siobhain Duggan - Category: Product serialisation, compliance with EU, FDA and other international drug pedigree requirements and establishing anti-counterfeiting solutions are key priorities for the pharmaceutical industry. The deadline for compliance with the European Falsified Medicines Directive (FMD) is 2017 for those countries that don’t have a pre-existing authentication system. All manufacturers will be expected to print a 2D datamatrix with serialisation data on medicine packs and these packs then need to be verified at the point of dis...

Healthcare systems around the globe are facing challenges that affect the entire supply chain.  The sector is concerned primarily with two main issues: patient safety and greater supply chain efficiency and accuracy.  The facility to identify things uniquely and accurately is essential - be it a medication, an item of clinical equipment or even a patient.  The regulatory landscape continues to evolve globally.  New regulations in the EU, the US and elsewhere will have a major direct impact on the healthcare supply chain...