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  - 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...