Global product identification specialist Domino has formed a European group dedicated to helping pharmaceutical manufacturers comply with the new stringent regulations contained in the European Union’s Falsified Medicines Directive (FMD) implementation - 2001/83/EC - which is now under way.
The group consolidates Domino’s industry-leading expertise in the consultation and implementation of established pharmaceutical legislative compliance solutions. The group includes specialists in all the critical disciplines, including legislative standards, validation of automated manufacturing good practice, code formats, serialisation, the successful implementation of turnkey solutions.
The group comprises local experts across Europe backed up by a team of specialists who will coordinate Domino’s FMD activities as well as monitoring likely developments in the global harmonisation of standards.
The falsified medicines directive (2001/83/EC) incorporates a series of initiatives to help safeguard the supply chain and protect patients, including measures to regulate Internet sales of medicines and strengthen record-keeping requirements. Most significant for manufacturers, however, will be the introduction of obligatory identification and authenticity features on outer packaging of medicines, including a unique, non-predictive number and tamper-evident labelling.
Following the publication of the Falsified Medicines Directive by the Council of the European Union in July this year, member states have just 18 months to transpose the Directive into national law. Manufacturers then have three years be compliant.
“The FMD’s schedule represents a challenging scenario for manufacturers,” says Craig Stobie, head of the new Domino group. “While the timetable is fixed, vital details are still to be finalised, especially concerning the identification features that medicines will have to incorporate—at the moment all we know for certain is that a key element will be a pan-European requirement for unique serial numbers on each genuine medicine pack. While it’s very likely that the data carrier will be the ECC200 2D Datamatrix barcode, other barcode types and RFID have also been mentioned. There is also a debate about the most suitable standards, with a lot of details yet to be decided.”
“Domino’s FMD Group gives manufacturers access to the experience we have amassed in over 20 years developing and manufacturing pharmaceutical coding and legislative compliance solutions. We believe our support is unrivalled in its breadth and depth, ranging from class-leading coding technology to in-depth understanding of the solutions currently in operation in countries such as France, Turkey, Italy, South Korea, India, Belgium, Brazil and China. We are also the only supplier with a dedicated validation department to ensure compliance with GAMP 5, 21 CFR Part II and EU Annex II requirements.”
Domino supplies market leading coding devices, including Thermal Inkjet and Laser, and has established successes with all leading technology partners and OEM suppliers which gives Domino a unique holistic understanding of the challenges required.
Posted on Monday 10th October 2011