Tag Archives: EUDR

The Most Head-Scratching Section Of The FMD

I found this sealed OTC product in my own closet. Note the round clear adhesive seal between the four yellow arrows. Would this anti-tamper seal render this product illegal in the EU after next February?

Just after I posted my last FMD essay on RxTrace (see “FMD, One Year Out”) I found out that the European Commission had published version 9 of their “Safety Features for Medicinal Products for Human Use, Questions and Answers”.  This is must reading for anyone with questions about how to interpret the most confusing provisions of the Falsified Medicines Directive (FMD) (also known as EU Directive 2011/62 and which amends Directive 2001/83) and the Delegated Regulation (EUDR) (also known as EU Regulation No 2016/161) (see “The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning“).

With each major revision this Q&A document grows.  This time it grew substantially with the addition of 21 new questions and answers and updates to four previously posted answers.

But there is one provision of the FMD that defies explanation, even though the Q&A document burns two Q&As to attempt it.  That provision in the FMD is Section 1 of Article 45a, which basically says, in part, that you cannot put an anti-tamper device on non-prescription drugs unless the EC or a Member State specifically says you can.  What’s going on here? Continue reading The Most Head-Scratching Section Of The FMD

The FMD Product Code

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

Is Your Drug Too Small For The Mandated 2D Barcode?

Is your Drug Too Small?  Sample vial and syringe with barcode attached.
As an experiment, I taped the smallest DSCSA-compliant 2D barcode I could define to these sample vial and syringe from CCL Label. Notice that neither sample includes the required human readable text of the data encoded in the barcode, which means that these examples may not comply in some markets. The barcode on the vial is readable, but the one on the syringe is not readable because of the short radius of the barrel (about 5mm).

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?

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

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

Decommissioning Under the FMD/EUDR

iStock_83566139_smallerIt 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 stored in the repositories system referred to in Article 31 of this Regulation to a status impeding any further successful verification of the authenticity of that unique identifier;”

It is a striking omission to define how to change the active status of a drug to impede successful verification, but to fail to define the opposite operation that sets the active status to enable successful verification in the first place. Continue reading Decommissioning Under the FMD/EUDR

How Brexit Might Impact The Pharma Supply Chain

iStock_94550925_smallerA 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 had “won”, because they really didn’t mean it!  It’s also laughable to hear the cries of the people who didn’t bother to vote because they felt confident that the referendum would go their way.  Now they would like to go back in time so they can cast their vote.  Whoops, too late.

What these people didn’t realize is that revolutions are serious business, whether executed with guns or with votes.  One of the reasons Continue reading How Brexit Might Impact The Pharma Supply Chain

More Concerns With The FMD/EUDR Big Bang Start

iStock.Licensed.criminalThe 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