Create Blanket No Change Product Listing Files/Blanket No Change Certification Files

Blanket No Change Product Listing Files/Blanket No Change Certification Files are maintained under the Authorized Agent's tab of the Contacts/Entities Section. Selecting the Authorized Agents tab displays any existing Authorized Agents:

Select an existing Authorized Agent's name from the list, or click the "Create New Authorized Agent" link to add a new Authorized Agent.

Clicking an Agent's name from the list will display that Authorized Agent Detail page.

On the Authorized Agent Detail page, the “Blanket No Change Product Listing Files” link is used to view, create and download Blanket No Change Certification Product Listing submissions.

1. Existing Blanket No Change Certification Product Listing submissions are listed in descending order based on the version number.
2. Click the “New Report” button to create a new Blanket No Change Certification Product Listing submission. Populate the Effective Date and click “Save Header” button.

3. Select the products that should be included in the report and click “Save Products To Report” button. All selected products will appear in the “Selected Products” list on the right. The list of products contained in the SPL Portal customer repository that meet the following conditions will be shown:
   
   a) Any products (and associated NDC codes) that have not been listed on DailyMed during the current calendar year
   b) Any products that have been submitted via the SPL Portal ESG Gateway and have received an Acceptance notification within the current calendar year. NOTE: This allows for SPL Portal to take into consideration unfinished products that do not appear on DailyMed.
   c) To filter the list on the left by Labeler, select a Labeler from dropdown list.
   
   
4. When all products are added to the report, click the “Create SPL” button to generate the Blanket No Change Certification Product Listing report. Once it is generated, a download link will appear in the list at the top of the page. Additionally, if your company subscribes to the SPL Portal ESG Gateway service, a button will appear allowing submission via the gateway.
5. Click the "Create SPL Review File" button to create a Blanket No Change review file.