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The third party submitter is not authorized to subm

bcotton56
New Contributor II

Where in the app do i put my 3rd party (1world)  No matter where I put the info I get the c999 error.

16 Replies

Montavio
Moderator
Moderator

Hello, @bcotton56! I noticed that your DUNS number was added to your item instead of the 1 World Sync DUNS number, 037407777. Once the current DUNS added is swapped or this one, your issue should be fixed. Please let us know if the error continues after adding the 1WS DUNS!

bcotton56
New Contributor II

I have Key's in brand owner and 1worlds in additional trade item identification.  Changed brand owner to 1worlds, left additional trade alone.  now i get 

Registration attempt : 2023-09-07 08:59:42.0
Rel. Dependant : 1100001017041
Rel. Action : REVIEW
Status Detail : 000 00850041798004:CIC999:CoreId ci1694094667322.11144699@fdsahl88ceb438_te2MessageId <1694094667244.2406920576@lFQEy4Bka2ucfA==> STEP 4. The third party submitter is not authorized to submit for DUNS 037407777.
 

Hi bcotton56,

It looks like when you submitted the FDA UDI form you entered your DUNS number rather than 1WS DUNS number. Please work with the FDA to correct as I'm not sure if you can simply resubmit a new FDA UDI form or if there might be more to it.

Below is a snippet of the FDA Implementation Guide, the full guide can be found here:
https://community.1worldsync.com/t5/Solution-Docs/FDA-GUDID-Implementation-Guide/ta-p/3742

DanV_0-1694096738641.png

 

bcotton56
New Contributor II

NEED TO JUST REMOVE THIS ONE.  FOUND OUT THIS ITEM 00850041798004 WAS ALREADY ARCHIVED.

bcotton56
New Contributor II

CLONED IT AND STARTED OVER WITH 00850041798004

bcotton56
New Contributor II

SORRY, NOT ITEM IS 00850041798035

 

bcotton56
New Contributor II

cant type new item is 00850041798035

 

DanV
Moderator
Moderator

Hi bcotton56,

If your DUNs number was entered when you submitted the FDA UDI form any item you publish to the FDA will result in the same error. You must enter the 1WS DUNs number when submitting the FDA UDI form to allow 1WS to submit items to the FDA on your behalf (since 1WS is your Datapool provider any publications you send come to 1WS, then to the intended recipient).

Let us know if you have any questions.

bcotton56
New Contributor II

My gudid account lists 1world as the 3rd party.  I have key's duns listed as brand owner additional info, 1world duns as additional trade item identification.  Where should I have Key's duns listed and where for 1worlds?