topic Re: The third party submitter is not authorized to subm in Ask A Question for FDA GUDID

The third party submitter is not authorized to subm

bcotton56 — Wed, 06 Sep 2023 18:16:28 GMT

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

Re: The third party submitter is not authorized to subm

Montavio — Wed, 06 Sep 2023 20:37:35 GMT

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!

Re: The third party submitter is not authorized to subm

bcotton56 — Thu, 07 Sep 2023 14:09:40 GMT

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.

Re: The third party submitter is not authorized to subm

DanV — Thu, 07 Sep 2023 14:26:29 GMT

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

Re: The third party submitter is not authorized to subm

bcotton56 — Thu, 07 Sep 2023 15:16:52 GMT

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

Re: The third party submitter is not authorized to subm

bcotton56 — Thu, 07 Sep 2023 15:18:00 GMT

CLONED IT AND STARTED OVER WITH 00850041798004

Re: The third party submitter is not authorized to subm

bcotton56 — Thu, 07 Sep 2023 15:19:08 GMT

SORRY, NOT ITEM IS 00850041798035

Re: The third party submitter is not authorized to subm

bcotton56 — Thu, 07 Sep 2023 15:33:27 GMT

cant type new item is 00850041798035

Re: The third party submitter is not authorized to subm

DanV — Thu, 07 Sep 2023 16:02:54 GMT

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.

Re: The third party submitter is not authorized to subm

bcotton56 — Thu, 07 Sep 2023 20:08:51 GMT

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?

Re: The third party submitter is not authorized to subm

bcotton56 — Thu, 07 Sep 2023 20:09:35 GMT

Re: The third party submitter is not authorized to subm

bcotton56 — Thu, 07 Sep 2023 22:01:38 GMT

My gudid account lists 1world as third party. I do NOT need another account. If you look at production items, there are several places asking for duns numbers. Nothing I can find tells me which duns goes in which spot. That's what I need help with now.

Re: The third party submitter is not authorized to subm

DanV — Fri, 08 Sep 2023 12:03:28 GMT

Hi bcotton56

Use your Duns number in Item Management for attribute Brand Owner Additional Trade Item Identification Value:

Re: The third party submitter is not authorized to subm

bcotton56 — Fri, 08 Sep 2023 14:35:18 GMT

I have my duns number listed there now and item synced. Nowhere in by product lists 1world duns. Am I missing something?

Re: The third party submitter is not authorized to subm

DanV — Fri, 08 Sep 2023 14:54:24 GMT

Hi bcotton56,

Looks like you did submit the FDA UDI form with the 1WS Duns number that allows 1WS to send your items to the FDA on your behalf. If you received a Synchronized CIC back from the FDA you should be all set with that item.

TIP: Any items that were Synchronized in the Pre-Production environment can be extracted from Item Management Pre-Prod, on the FUSE extract set the Operation to ADD and Import Item to Y, then you can upload that FUSE extract in Production Item Management to create your item with all the attribute values you that are present in Pre-Prod.

Re: The third party submitter is not authorized to subm

bcotton56 — Fri, 08 Sep 2023 15:38:51 GMT

When will I be able to see my product in accessgudid

Re: The third party submitter is not authorized to subm

DanV — Fri, 08 Sep 2023 17:02:31 GMT

Hi bcotton56,

I dont see anything in the FDA Implementation Guide about any timing between the Synchronized CIC from the FDA and when your item will show in accessgudid, it simply states the below:

The process is complete when the CIC state of SYNCHRONIZED has been
received for all of the published items.

If you have not done so already please check for your item in accessgudid, if it is not present there, I would recommend reaching out to the FDA.