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 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

Sponsored: Pharma Traceability

May 22-24, Hotel Del Coronado, Coronado, CA

Pharmaceutical serialization and traceability laws continue to be developed all over the world.  In any one market, it takes several years to progress from the initial stirrings to the publication of full, workable regulations.  As we have seen, several countries have had to take a few steps back, make adjustments and then move forward again (see “Brazil Gets Rational With Their New Pharma Traceability Law” and “China’s Retreat From Pharma Serialization: Will This Become A Global Trend?”).  In fact, I think those countries that do, will end up with a much better approach.

What that means to you is Continue reading Sponsored: Pharma Traceability

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

Sponsored: The Season For Label Redesign

With the approach of pharma serialization deadlines all around the world, this is the season for label redesign.  The addition of new unique identifiers in 2D barcodes and human readable forms—often without removing existing linear barcodes—requires knowledge of the pharma labeling regulations in the target markets as well as artwork skills (see “DSCSA: Label Artwork Heartaches”).  The problem is, serialization doesn’t apply to just one product, it applies to all prescription drugs marketed in the target market.  That threatens to cause Continue reading Sponsored: The Season For Label Redesign

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

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

Sponsored: Brand Protection: The ‘No Brainer’ Value, Beyond Compliance

Pharma companies are spending a boat-load of money to put serial numbers on their drug packages and homogeneous cases, and collecting aggregation data for the wholesale distributors.  And in every one of those companies, their leadership is asking, “What can we do to get some value, beyond compliance, from our investments?  Can we sell someone some data?  Can we get some new business advantage?  Can we get some new insight into our processes or into the operation of the supply chain?” Continue reading Sponsored: Brand Protection: The ‘No Brainer’ Value, Beyond Compliance

One Immediate Impact of President Trump On The FDA

Most RxTrace subscribers are aware that the FDA is way overdue to publish four guidance documents mandated by the Drug Supply Chain Security Act (DSCSA) (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?” and “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?” for a list of the missing documents).  Two of those four documents could impact how some drug manufacturers deal with the November 27, 2017 deadline for full serialization of prescription drug products, depending on what the FDA says in them. 

Every day since the original due date of those documents (November 27, 2015) I have Continue reading One Immediate Impact of President Trump On The FDA

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

DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel
and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating
the positions of any company, organization or individual other than Dirk Rodgers.

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