Beginning in less than two weeks, all packages of prescription drugs entering the EU pharma supply chain must contain a 2D barcode encoding the EU serialized ‘Unique Identifier’ (see “The ‘Unique Identifier’ in the EU Delegated Act”). More importantly, all drugs that have an FMD unique identifier on them at the point of dispense after February 9, 2019 must be “verified” and decommissioned through the National Medicines Verification System (NMVS) (see “What’s So Hard About Unique Identifier Verification?” and “Decommissioning Under the FMD/EUDR”). It looks like my prediction of FMD delays was wrong (see “How Will They Delay The FMD?”) but at least Denmark has just moved to solve a serious FMD dilemma with a kind of delay. Let me explain.Continue reading FMD: Denmark Moves To Solve FMD Dilemma
Most regulations dictating the application of unique identifiers on drug packages also dictate specific data be encoded into a machine-readable barcode, and human readable text. The purpose of the machine-readable unique identifiers is obvious–to allow computers to read the product’s unique identifier quickly and accurately. The purpose of the human-readable unique identifier is less well-understood. Many believe it is to allow manual entry of the barcode contents when the barcode is unreadable for any reason. Others believe it is Continue reading How To Accept Manual Entry Of Drug Unique Identifiers
Both, the Drug Supply Chain Security Act (DSCSA) in the US and the Falsified Medicines Directive (FMD) in the EU make use of unique identifier verification in one way or another. Under the FMD, verification is the centerpiece of patient protection. Under the DSCSA, verification is used as a tool to help resolve higher risk use cases, like saleable returns to wholesale distributors, and anytime someone becomes “suspicious” about a collection of drug packages. On the surface, verification of unique identifiers seems simple, but there are some sticky problems that make it complex in some circumstances (see also “Drug Verification: EU Vs US”). Continue reading What’s So Hard About Unique Identifier Verification?
Under the Falsified Medicines Directive (FMD), starting on February 9, 2019 drug manufacturers must begin affixing a new Unique Identifier and an anti-tamper device to all consumer packages of prescription drugs (see “The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning”). The Unique Identifier must be composed of a Product Code, Serial Number, Batch Number, Expiration Date and, where required, a National Reimbursement Code (see “The ‘Unique Identifier’ in the EU Delegated Act”). This data must be uploaded to the E.U. Hub prior to shipment into the supply chain. All of the details are spelled out in the Delegated Regulation (EUDR).
One of the more interesting aspects of the FMD/EUDR is the Product Code. Continue reading The FMD Product Code
RxTrace readers are already well aware that multiple new laws around the world will require prescription drug manufacturers to put a new 2D barcode on their products in the next few years. But what if your drug package is too small to fit the new mandated 2D barcode and human readable information on the label? Let’s take a look at what the regulations say in the E.U., Brazil and the United States. From that, we can come up with some strategies. Continue reading Is Your Drug Too Small For The Mandated 2D Barcode?
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 Russian Minister of Health, Veroníka Skvortsova, signed the guidelines document for the pilot. The 42-page document appears to be written as a pilot setup document, as opposed to Continue reading The Russia Serialization Pilot Guideline
The key part of Article 50 of the European Union Delegated Regulation (EUDR) says: “This Regulation…shall apply from 9 February 2019.” That’s the date of the “big bang”—the date everything takes effect. On that date, all drugs entering E.U. markets (except in Italy, Belgium and Greece) must contain the two safety features called out by the regulation on their packaging, including an anti-tamper device and a compliant Unique Identifier (see “The ‘Unique Identifier’ in the EU Delegated Act”). It is the date by which “National Competent Authorities” in each of the EU member states (except the three listed above) must offer a data repository for the covered drug products that are targeted at their local market. And it is the date on which dispensers (called “persons authorised or entitled to supply medicinal products to the public” in the text) must begin using the system of repositories to “…verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public…”. All on the same day. The day of the “big bang”.
This “big bang” start will result in some problems. Continue reading More Concerns With The FMD/EUDR Big Bang Start
Ever since the E.U. Falsified Medicines Directive (FMD) was passed in 2011 my European friends have touted the fact that their government mandated solution would take a “bookend” approach. The implication was always that it would be much less complex than the ePedigree approaches that were being planned by various U.S. states, and then by the U.S. federal government with the passage in 2013 of the Drug Supply Chain Security Act (DSCSA).
My friends always liked to point out how simple Continue reading EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary