The EU Delegated Regulation (EUDR) of the Falsified Medicines Directive (FMD) mandates that all serial numbers placed on non-exempt drugs entering the EU supply chain after February 9, 2019 must be ‘sufficiently randomised’. What is sufficient randomisation? The regulation says one thing, and the European Medicines Verification Organization (EMVO), the operator of the EU Hub, says something beyond that. What should drug manufacturers do? The EMVO recently updated their messaging. Let’s take another look at this important topic. Continue reading EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored
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 a lot about the EUDR over the last few years (see RxTrace: Delegated Regulation). Today I want to highlight and explain a problem that may be brewing in the implementation of the system of repositories as established by the non-profit European Medicines Verification Organization (EMVO). The potential problem is related to the way the EMVO Continue reading Pharma Serial Number Randomization Under The Falsified Medicines Directive
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
Last week, the National Agency of Sanitary Surveillance (ANVISA), the healthcare regulator in Brazil, published a draft of their proposed pharma serialization regulations aimed at meeting the requirements of the new law number 13.410 of December 28, 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”). The purpose of this new publication is to solicit comments from interested parties. It is called “Public Consultation No. 311 of February 15, 2017”. This is not a final regulation—the public consultation ends on March 17, 2017, after which changes to the text, based on the feedback collected, are likely before it becomes final—but it provides us with a solid view of ANVISA’s thinking, and that amounts to a big win for the industry, and for Brazil. Now is the time to read it over and submit your comments to help make it even better. Continue reading ANVISA Reveals Draft Serialization Regulation and Asks For Comments
As serialization mandates sweep the world you would think that drug manufacturers and repackagers would just deploy one generic “serialization application” and simply turn it on for any drugs that requires it, and turn it off for any that do not. That’s probably what the legislatures and regulators who create the requirements think. RxTrace readers know it’s not nearly that easy.
The problem is that every regulation requires something different. The only common thread is that there is always a “serial number” requirement in there somewhere (thus the name). But the serial number itself is usually defined differently and everything else that surrounds the serial number is often not the same. It’s not a matter of just turning it on and off, it’s a matter of changing a bunch of parameters, which result in significantly more complexity in the setup, testing and validation of the system for each market. Continue reading Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution
Do you need to understand the U.S. Drug Supply Chain Security Act (DSCSA) but do not have time or budget to attend a conference? Webinars are the ideal way to get the same information you would collect at a conference without the travel hassles, expense and lost time. That’s why Riya Cao of LSPediA and I have decided to offer a new series of webinars aimed at various important DSCSA topics. We have announced three initial dates and topics and registration is currently open for all three. They include: Continue reading New DSCSA Webinar Series
Before the passage of the Drug Supply Chain Security Act (DSCSA) on November 27, 2013, the pharma industry was focused pretty well on getting the California-mandated serial numbers on 50% of their drug packages by last Thursday (January 1, 2015), and the remainder of their products by next January. But that mandate evaporated by federal preemption as soon as the Federal bill was signed into law. From that moment on, everyone turned their sights toward meeting the data exchange requirements of the DSCSA by last Thursday (see “DQSA: How Should Transaction Data Be Exchanged?”). Of course, just before Christmas, the FDA pushed that effective date out to May 1, 2015 (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).
That extension in enforcement is a blessing to a few Continue reading Pharma Industry Attention Returns to Serialization
Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain. Let me explain.
The text of the Drug Supply Chain Security Act (DSCSA) was developed last year by Congressional staff in consultation/negotiation with various lobbying organizations—primarily the Prescription Drug Security Alliance (PDSA). The effect of the legislation is to create a way of protecting the U.S. pharmaceutical supply chain that relies primarily on product identifier authentication (PIA) (see “Product Identifier Authentication” and “The Aggregation Hoax and PIA”) for at least the first 10 years and possibly beyond. Continue reading DSCSA: Congress Should Have Mandated Randomization