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?

Find the new version of the Q&A here.  An ”anti-tamper” device is one of the two “safety features” the FMD mandates.  The other is the Unique Identifier (see “The ‘Unique Identifier’ in the EU Delegated Act”).  People don’t talk much about the anti-tamper device because the FMD and EUDR do not say much about it.  My understanding is that an anti-tamper device is anything that prevents you from opening the drug package.  I believe this would include things like the heat-shrink sleeves placed over the cap of a bottle, or the clear plastic seal that holds a folding carton closed until you cut through it.  I’m sure there are many others.

The whole point of an anti-tamper device is to serve as a “red flag” to patients and medical professionals when they want to open a package, that someone else has already opened it and may have tampered with the contents.  If that was unexpected, they know not to use the drug.

For non-prescription—Over-The-Counter (OTC)—drugs, the pertinent part of Section 1 of Article 45a of the FMD says:

“Medicinal products not subject to prescription shall not bear the safety features […], unless, by way of exception, they have been listed [in Annex II of the EUDR], after having been assessed to be at risk of falsification.”

At the time the EUDR was first published, Annex II listed just two non-prescription drugs that must follow the FMD/EUDR throughout the EU, including both safety features.  These are 20mg and 40mg packages of omeprazole.  The EUDR also allows any Member State to specify certain non-prescription drugs that must follow the FMD and EUDR within their own territory.  I am aware of only two Member States that have flirted with expanding coverage to include reimbursable OTC drugs:  Belgium and France.  In the end, I’m not sure we’ll see either one keep that mandate starting on day one.  Maybe later.

If you are a manufacturer of over-the-counter (OTC) drugs marketed within the EU, other than omeprazole, you are off the hook.  You do not have to apply the safety features to your packages (but keep your eyes on Belgium and France).


But what if, as the manufacturer, you want to add one of the two safety features—an anti-tamper device—to some of your OTC products, other than omeprazole?  You don’t have to, but can you do it voluntarily?  Let’s check the Q&A document.  Question/Answer number 1.10 and 1.11 both apply to this situation:

“1.10. Question: Once Regulation (EU) No 2016/161 applies, can manufacturers place the safety features, on a voluntary basis, on medicinal products not required to bear the safety features?

Answer: No. Once Regulation (EU) No 2016/161 applies, manufacturers cannot place the safety features on medicinal products not required to bear the safety features, unless the Member States have extended the scope of application of the unique identifier or of the anti-tampering device to those medicinal products in accordance with Article 54a(5) of Directive 2001/83/EC.”

“1.11. Question: Certain medicinal products are currently bearing an anti-tampering device on a voluntary basis. Are those products allowed to maintain the anti-tampering device once Regulation (EU) No 2016/161 applies, if they are not required to bear the safety features?

Answer: Once Regulation (EU) No 2016/161 applies, medicinal products can only bear an anti-tampering device if they are in the scope of Article 54a(1) of Directive 2001/83/EC (i.e. if they are medicinal products subject to prescription or medicinal products listed in Annex II of Regulation (EU) No 2016/161) or if the Member State(s) where they are placed on the market extended the scope of the anti-tampering device to those medicinal products.”

According to these extracts the answer is ‘no’, you cannot put an anti-tamper device on your OTC drug packages in the EU after February 9, 2019, other than omeprazole, or unless an individual Member State says you must.  And by the way, if your OTC product, other than omeprazole, already has an anti-tamper device on it, you’d better stop putting it on new packages before next February because that practice will be illegal on the 9th of February, 2019.


Another OTC product on my shelf with the safety seal still in place (see red arrow). Would this kind of thing be illegal next February in the EU?

This provision and the associated Q&A above have left a lot of people scratching their heads.  Why are we dictating the removal of existing features that were placed on product specifically to increase patient safety?  Doesn’t increased safety align with the spirit of the FMD and EUDR?  After all, they are called “safety features”, right?  As in, “these features are for your safety”.  Wouldn’t more safety features—even when not specifically required by law—generally increase the safety of the general population?

I’m one of those people who are scratching their head.  I’m from the United States, and I’m old enough to remember the event here that resulted in the most rapid deployment ever—anywhere—of equipment needed to apply anti-tamper devices on OTC products.  It happened in the fall of 1982 in the northwest suburbs of Chicago.  Seven people died from cyanide poisoning after taking a dose of a very popular OTC pain reliever.  I don’t even have to name the product.  Anyone in this industry from the United States will know what I’m talking about.

Incredibly, at that time, there were no anti-tamper devices on bottles of OTC pain reliever—or any OTC drug product.  This particular product was sold in bottles of capsules that contained a white powder.  Someone found it very easy to open several bottles in multiple drug stores and slip in a small number of capsules containing cyanide.  The most incredibly sad part of this story is the family who’s grief over the sudden, unexpected death of a family member was so deep that, before the authorities knew what had caused the death, two more family members unknowingly each took a dose of the pain reliever from the same bottle that their loved one had taken from—to help them sleep.  They both quickly fell ill and died.  In fact, this is when suspicion fell on the bottle of pain reliever, leading to an urgent, massive recall.

This was in the days before saturation video taping of store aisles.  The case has never been solved, and the Police file remains open today.  Within weeks Congress passed a law requiring anti-tamper devices on all OTC drug products.  Today, every consumable product on store shelves is sealed in a way that provides tamper evidence.

So what is going on in the EU?  Admittedly, today in the EU, there probably aren’t any OTC products that are as open to tampering as that pain reliever was here back in 1982.  Most drugs there—including OTC drugs—are sold in blister packs, which are already highly tamper evident, inside of cartons.

Back in October of 2015 Iiro Jantunen, CTO at Servicepoint Oy posted a great essay on this very topic.  His theory at the time was that perhaps:

“The OTC drug manufacturers have lobbied hard to prevent the possibility of one manufacturer competing against the others with a safer, safety-included, medicine.”

Whatever the actual reason, the provision just doesn’t make sense to me.  Does it make sense to you?  Can anyone explain the logic behind it?