Geoff LeCain

The “View Associated Product Listings” link is used to view all “private label” products in the data repository associated with the specific registrant.  A product is designated as “private label” ...

Answer: You can have the Portal send you email notifications when your products have been uploaded to the NLM and you can later add additional email addresses to be copied on the notifications. Sim...

The application allows users to toggle between versions of labeling content by using one of three radio buttons: Current/Checked-In – This is the baseline version.  This version contains the most...

Answer: An SPL file must accompany all submissions that propose changes to the content of labeling, including certain amendments, submissions of final approved content of labeling and annual reports.

The Content Editor page also displays information about the Identifier, Listing and Effective date.

The “Wholesale Distributor/3rd Party Logistics Files” link is used to create and download Wholesale Distributor/3rd Party Logistics submissions files. This link will only be displayed if an Establ...

Answer: XML is a specification for creating custom markup languages for sharing structured data. SPL is a standard that uses XML.

If you select the Current/Checked-in radio button, the content of the baseline version is displayed in READ ONLY mode in the bottom panes on the screen and it cannot be changed.  If you want to mak...

The “US Agents” tab provides the ability to view and create agents in the data repository.  To edit an existing agent, click on the US Agent’s name in the table and make modifications as needed. ...

Answer: You should only update your listings if there has been a significant change to the content of labeling. You are not required to update annually unless there are reportable changes made to t...