Serializing Product Groupings Under Global Regulations

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

Drug Samples Under Global Serialization and Tracing 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 ‘Unique Identifier’ in the EU Delegated Act

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

Pharma Serial Number Randomization Under The Falsified Medicines Directive

Drug companies who serve markets within the European Union (EU) have until February 9, 2019 to add serial numbers within a Data Matrix barcode to their drug packages, among many other specific requirements (see “The ‘Unique Identifier’ in the EU Delegated Act”).  The specific requirements are outlined in the EU Delegated Regulation (EUDR).  I’ve written … Continue reading Pharma Serial Number Randomization Under The Falsified Medicines Directive

The Russia Serialization Pilot Guideline

The Russia Ministry of Health (MoH) is conducting a serialization and tracing pilot with a number of supply chain members between February 1, 2017 and December 31, 2017 (see “Russia Begins Its Pharma Supply Chain Pilot”).  The MoH is due to publish an assessment of the pilot by next February 1st.  Two weeks ago the … Continue reading The Russia Serialization Pilot Guideline

DSCSA: Saleable Returns Verification

The Healthcare Distribution Alliance (HDA) Traceability Seminar that was held back in early November was so packed with valuable information that I still have a number of topics queued up from that event for RxTrace essays in the future.  Today I want to take a closer look at the results of the Saleable Returns Pilots … Continue reading DSCSA: Saleable Returns Verification

Decommissioning Under the FMD/EUDR

It is a little surprising that the European Union Delegated Regulation (EUDR) uses a form of the word “decommission” 67 times, but not even once uses the opposite term, “commission”.  Article 3.2(c) of the EUDR defines the term ‘decommissioning of a unique identifier’ as: “… the operation changing the active status of a unique identifier … Continue reading Decommissioning Under the FMD/EUDR

How Brexit Might Impact The Pharma Supply Chain

A revolution occurred last week.  Not by guns—by referendum.  Like most revolutions, it caught a lot of people by surprise.  The most laughable surprise comes from those who voted for the UK to leave the European Union as a kind of protest vote, but immediately became sorry they voted that way after learning that they … Continue reading How Brexit Might Impact The Pharma Supply Chain