The European Medicines Agency Offers Recommendations on Pack Design and Labeling

The European Medicines Agency has released recommendations on pack design and labeling for centrally authorized non-prescription drugs and is accepting industry comments through June 30. While such labeling currently must comply with Title V of Directive 2001/83/EC, package design does vary depending upon member states. The EMA offers its advice on the placement and treatment of certain medication information in an effort to encourage proper selection and use.

The draft document summarizes general pack design and layout as well as the use of symbols and pictograms, offering specific recommendations. For instance, the medicine name should appear in a large font and be used in "three non-opposing sides of an outer carton (including one end panel)," reads the document. The administration route should be displayed "in the same field of vision as the rest of the critical information," and the "largest type size possible should be used on all components." continued

Standing Together to Meet Global Serialization Rules

A new system launched in Brazil at FCE Pharma is designed to offer a stand-alone solution to support different approaches to pharmaceutical product serialization. VisioCIT can handle either labeling or direct coding, reports Christoph Lehmann, director of Uhlmann VisioTec GmbH, which can position companies to meet Brazil's pending rules as well as others around the world. "The development was driven by Brazil's T&T law, which on one hand asks for the application of preprinted labels, but on the other hand might be direct coding," Lehmann told PMP News. "We thought, why not build a jack-of-all-trades system to cover all? And funny enough, we already have positive feedback from other countries for this concept machine."

The system is built on the platform of Uhlmann's L250 bottle labeling system, so the basic framework is standard, says Lehmann. The new system combines product handling and checkweighing equipment from OCS Checkweighers; a label dispenser and platform from Pago Labeling; and track-and-trace software, vision inspection technology, and additional coding technology if needed from Uhlmann VisioTec. Uhlmann serves as the turnkey system provider to help customers with initial specifications, installation, and use. continued

Preparing for Pharmaceutical Traceability

The European Directorate for the Quality of Medicines & Healthcare (EDQM) has developed a service to support nonproprietary solutions for pharmaceutical traceability. EDQM's system is intended to serve as a public service for product verification, explains Francois-Xavier Lery in EDQM's Department for Biological Standardisation, OMCL Network and HealthCare (DBO). "Live demonstrations mimicking the supply chain using ERP software powered by SAP and IBM are expected later this year," he explains.

While the EDQM system is intended to "capture product information from packages as well as on shipping," he explains, "it is not an electronic pedigree system and can support an end-to-end approach. But the scope goes beyond to enable patients to conduct verification such as through a smart phone." continued