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Labeling Requirements - Medical Device is Rx in USA, non-Rx in EU

G

geglee

#1
Hi,

What about printing "Rx only" to this single product label? The tricky issue is CE is not Rx but FDA is. Would there be any issues when entering the CE market? Thanks.
 
M

MIREGMGR

#2
Re: Labeling--Device is Rx in USA, non-Rx in EU

My understand would be that that won't work as a single label. Separate product versions for USA and EU, each with their own label, will be required.

It's conceivable that you might be allowed to use a label with something like

USA: Rx Only
EU: OTC

but my understanding is that both US FDA and EU authorities will jump on this approach as potentially confusing if/when they become aware of it.

You however could inquire directly to FDA, probably starting with DSMICA, if you wanted to pursue that direction.
 
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