What is a counterfeiter to do today? Governments around the world are moving
toward standardized serialization and track & trace requirements aimed
directly at their bottom line. It’s
getting harder to fake your way past supply chain workers who are increasingly educated
on what to look for and how to raise their suspicions to the authorities. Or is it?
Let’s take a closer look.
Last week the European Medicines Verification Organisation (EMVO) sent a letter to all of their “Onboarding Partners” (OBPs), or drug marketing authorisation holders (MAHs) informing them of a problem EMVO is seeing with many of the expiration dates on drugs being uploaded. The problem they highlighted in the letter has been recognized by people around the world, and each country has decided to handle it slightly differently. Drug manufacturers should be aware of these differences to ensure compliance and avoid false failed verifications. Let’s take a closer look at the issue and what each country expects you to do about it.
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?
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→
Some pharma manufacturers make special packages of certain drugs that they give away to certain medical practitioners as a way of promoting the product and introducing the practitioner and their patients to it. The method of distribution is usually through field sales people employed directly by the drug manufacturer, and the drug samples are delivered by them directly to the practitioner.
What could go wrong with that? Probably diversion of the product contained within the “free sample” packaging back into the supply chain, but without the “free sample” indicator on the package. Should these special packages be tracked? Should they be serialized? Continue reading Drug Samples Under Global Serialization and Tracing Regulations→
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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