A “product grouping” is any collection of saleable units of products that are bound together in some way. They can be “bundles”, homogeneous or non-homogeneous cases, totes, pallets or something like these. The pharma serialization regulations in some markets call out some of these groupings for special treatment, and some do not. I’ll try to … Continue reading Serializing Product Groupings Under Global Regulations
Some pharma manufacturers make special packages of certain drugs that they give away to certain medical practitioners as a way of promoting the product and introducing the practitioner and their patients to it. The method of distribution is usually through field sales people employed directly by the drug manufacturer, and the drug samples are delivered … Continue reading Drug Samples Under Global Serialization and Tracing Regulations
The European Commission published a discussion draft of the European Union Delegated Act (EUDA) about two weeks ago (See “Breaking News: The EC Has Published The Delegated Act“). The EUDA was called for in the Falsified Medicines Directive (FMD) back in 2011 and is primarily intended to define the “safety features” that must appear on most … Continue reading The ‘Unique Identifier’ in the EU Delegated Act
Without true interoperability, will DSCSA 2023 ever happen?
Verification is arguably the most important concept in drug serialization and tracing regulations. What makes it so hard to get right?
Can you put an anti-tamper device on OTC drugs in the EU after next February? Surprise! No.
Will the FMD go into effect on-time in one year? Will there be problems? Will there be doom? Probably; Yes; Probably not.
Should the US pharma supply chain stakeholders create a National Medicines Verification Organization like the EMVO?