Shelf Life Extension - How to ReLabel Boxes?

Dudes

Inactive Registered Visitor
#1
I would like to extend the shelf life of a product (class III). How should I label the existing products once the extension is approved by the notified body?

If I were to only replace the label on the shelf box, I would have a conflict between the expiry date on the primary packaging and that on the box. Is there a way to avoid complete repackaging (like put an additional sticker on the outside shelf box)?
 

The Specialist

Quite Involved in Discussions
#3
Re: Shelf life extension - how to label?

You will not be able to over-print current labels, or 'place-over'.

You can also not have two conflicting labels on your secondary packaging.

Removal of current secondary packaging labels is ok.

Otherwise, repackaging is your only option.
 
K

Ka Pilo

#4
Re: Shelf life extension - how to label?

I would like to extend the shelf life of a product (class III). How should I label the existing products once the extension is approved by the notified body?

If I were to only replace the label on the shelf box, I would have a conflict between the expiry date on the primary packaging and that on the box. Is there a way to avoid complete repackaging (like put an additional sticker on the outside shelf box)?
Who conducted the first shelf-life studies? Please elaborate a little bit on the sample used, test parameters, methodology that resulted in conclusion of original shelf-life. And what’s the basis for extension?
 

Dudes

Inactive Registered Visitor
#5
Re: Shelf life extension - how to label?

Are you able to remove the labels on your secondary packaging without causing damage?
No, it can't be removed without damaging the cardboard.

Who conducted the first shelf-life studies? Please elaborate a little bit on the sample used, test parameters, methodology that resulted in conclusion of original shelf-life. And what’s the basis for extension?
The problem isn't the extension itself, it is pretty straightforward with the results of a study, but how to label retroactively lots for which the shelf-life has been extended.
 

Dudes

Inactive Registered Visitor
#6
Re: Shelf life extension - how to label?

You will not be able to over-print current labels, or 'place-over'.

You can also not have two conflicting labels on your secondary packaging.

Removal of current secondary packaging labels is ok.

Otherwise, repackaging is your only option.
My idea was to add a sticker on the secondary packaging - without hiding any information, informing the client that the shelf life had been extended by x years after approval by the notified body. As I see it, it will not be conflicting because no date would be on that label (it would be generic). I don't see anything in the MDD against this, but I don't know if it's a good idea...
 

The Specialist

Quite Involved in Discussions
#7
Re: Shelf life extension - how to label?

My idea was to add a sticker on the secondary packaging - without hiding any information, informing the client that the shelf life had been extended by x years after approval by the notified body. As I see it, it will not be conflicting because no date would be on that label (it would be generic). I don't see anything in the MDD against this, but I don't know if it's a good idea...

I see...

this is a little clearer.

I am not sure of the official stance on this, given your scenario.

I cannot 100% advise you on this (i'll look into it now though), re 'statement label'.

I don't like it though!!!


Will all pertinant batch information (on the original label) still be valid?
 

Dudes

Inactive Registered Visitor
#8
Re: Shelf life extension - how to label?

Yes, everything else remains valid.

I've seen it done elsewhere, that's why I am thinking of doing it this way.

The only "risk" of doing it this way would be that the client doesn't understand the new label and uses the old shelf life instead of the extended one. which is a commercial risk and has no safety impact...
 

The Specialist

Quite Involved in Discussions
#9
I'd be interested in reading what other forum members think on this issue, but as I have not had personal experience with this or seen any convension specifically pertaining to your method (solution) I would not like to advise you any further.

I will, however, assist in the search for information regarding this issue as it has caught my interest.
 

The Specialist

Quite Involved in Discussions
#10
I stumbled accross this (subpart D)

Does it help?

TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER H--MEDICAL DEVICES

PART 801 -- LABELING
Subpart D--Exemptions From Adequate Directions for Use

EDIT: (detail removed in light of more recent findings - link provided in later post)
 
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