Tag Archives: GTIN

Russia, serialization

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 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 →

DSCSA, HDA

Dawn of HDA’s Origin, The Key to DSCSA Compliance

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This week at the Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo (DMC) the HDA and ValueCentric will provide much more detail around the new master data sharing service they plan to make available in July.  The new service—named “Origin”—is intended to provide members of the pharma supply chain with a single directory of master data for all prescription drugs marketed in the United States (see Origin website).  That is, it is a database of master data wrapped within a cloud-based service. 

Origin master data is composed Continue reading Dawn of HDA’s Origin, The Key to DSCSA Compliance →

ANVISA

ANVISA Reveals Draft Serialization Regulation and Asks For Comments

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 →

China

The Intrigue Contained In The New China Drug Code

The CFDA “Bit Code”

Over the last few weeks, the pharma serialization and tracing landscape has begun to shift in China.  The China Food and Drug Administration (CFDA) announced a new use for an existing “National Drug Code” in Public Notice 2017-1 that, according to Google Translate (a helpful but very imperfect translator), will be referred to as the “Bit Code”.  In addition, a new notice has appeared on the AliHealth-hosted web portal that drug companies have been using for the last seven years or so to obtain serial numbers for their drug packages.  Automated translation tools leave too much to speculation so companies should not use them for compliance purposes.  However, here are my thoughts/speculation on what is happening.  Continue reading The Intrigue Contained In The New China Drug Code →

SSCC

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 catalog what we know about product groupings in each of the current, known regulations. Continue reading Serializing Product Groupings Under Global Regulations →

HDA

First Meeting of the HDA Verification Router Service Task Force

Happy Martin Luther King Jr. Day!

As someone who often attempts to explain truth and reality through writing, I can really appreciate the writing skill of Rev. Dr. Martin Luther King Jr. (see “Celebrating Martin Luther King Jr.”).  I’ve learned that the best writing has to come from your heart just as much as it does from your head, but I still make mistakes that I don’t expect to see in Dr. King’s writing.  Last week is an example.  By attending the Healthcare Distribution Alliance’s (HDA’s) Verification Router Services (VRS) Task Force meeting in Crystal City, Virginia, I learned more about HDA’s intentions for the design of the VRS. Continue reading First Meeting of the HDA Verification Router Service Task Force →

NDC

NDC Nearing Its End, Afflicted by ‘Identifier Failure’

business-executive-and-his-energy-level-concept-vector-cartoon-i-507717540_4911x3472Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing.  My mother and my mother-in-law both suffered from heart failure during their decline.  Analogous to heart failure in humans is a condition of an identifier system that is near the end of its useful life that we can call “identifier failure”.  At the end of November, a new FDA final guidance called “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” went into effect.  Buried deep within this 200+ page document is the official announcement that signaled the National Drug Code (NDC) identifier system is now afflicted with this end-stage condition.  The NDC won’t last long now, and there is no longer any excuse for inaction.  The need for a replacement is now urgent. Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’ →

GS1

Product Identification And National Registration Codes

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iStock_000090544423_smallerThere is a long-running tug-of-war going on between GS1 and national governments around the world over how exactly to identify medical products, whether devices or pharmaceuticals.  National governments regulate those products to maximize the health of their citizens and so they take a natural interest in how they are identified.  They want to eliminate all ambiguity between products within their market.  They need to be able to tightly grant market authorization, revoke it and oversee recalls when warranted.  To do that effectively, they need a way of clearly and concisely referencing a given product.  That same way of referencing the product should also be used for patient education and for healthcare professional prescribing.  Bad things happen when mistakes are made in the identification of healthcare products.

GS1 offers a global standard way of identifying Continue reading Product Identification And National Registration Codes →