Hello Kathleen,
Indeed this is getting to be a real issue and unfortunately the regulatory authorities mandating these information are not being very pragmatic ... at all. Completely agree with Hannes there should be some harmonisation in the world for the labelling and how this is handled, but every country wants to do their own thing. It always reminds me when FDA called their UDI database the Global Unique Device Identification Database ...
GLOBAL being the key word. Now in a couple years there are going to be minimum 6 or 7 databases UDI experts will have to update. The concern with space on labelling is really an issue and unfortunately regulators are not providing the flexibility in the 21st century. And indeed going against all of the mandates by governments around the world to become more "green" and reduce packaging. I have seen packaging increasing because of need to regulatory information, UDI, etc.
There are many ways I have seen companies addressing this, if there are packaging spaces which can be used, this is usually not an issue. However, when there are small devices and small packaging this gets to be a large concern. The suggestions above have been ones I have seen where companies are generally trending toward 1) separate "country configuration" of labelling or 2) switching over to e-labelling methods. If I could comment a little further (rant maybe), I do not see why this information needs to be on the actual label itself for the product. In fact, I think it causes more confusion than anything because the end users do not need who is the in-country representative. Often customers call the in-country representative to file a complaint which is more frustrating for the customer because they end up hearing, "We are the authorised representative, please call ..." This is primarily for the regulatory authorities. U.S. FDA does it right where this does not need to be on the label, nor even on the IFU. Where it needs to be is in the establishment registration database so the regulatory can contact the local in-country representative. Hopefully, EU, UK, Swiss, etc., will start using some brain matter and understand it is 2021 with much available information being able to be kept in databases and not on the actual product where honestly it is not relevant.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Sep-2021 10:20
From: Jackie Jaskula
Subject: Crowded labels with EU, UK, Swiss, etc representatives
Following...
We have the same issue. Our operations team is really pushing to have the 5 primary languages on the label as well. We may need to increase our packaging size a bit to accommodate the regulatory and operational requirements.
Jackie
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Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
Warsaw, IN
USA
Original Message:
Sent: 10-Sep-2021 16:08
From: Kathleen Aras
Subject: Crowded labels with EU, UK, Swiss, etc representatives
With all the new requirements for representatives in multiple jurisdictions, such as EU, UK, Switzerland, India, etc. that must be displayed on the product or packaging label, our labels are getting very tight on space. We can't be the only ones encountering this. What actions are others taking to meet the regulatory requirements for including the representatives name and address while not overloading your labels? Is anyone using lack of space as a reason to move this information to the IFU only? Any ideas and suggestions are welcome. Thanks!
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Kathleen Aras
SUGAR LAND TX
United States
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