Meeting+Minutes+Jul+22+2009+DL&ER+Workgroup


 * 1.** **Submission of SPL file through eGateway:**

For many companies, the publishing group receives the final SPL file to submit through the eGateway. The publishing group is a separate entity than the group that originates the SPL files, so the process of submitting is new to them. Validation issues also come back to the certificate holder for the eGateway, so this is usually the publishing group. The member of the group are not familiar with the errors so they usually have to relay them back to the group that authored the SPL file. This gets complicated when each member of the publishing group has his/her own eGateway account. Some companies' policies state that users are to log into their account using only their own ID and password. If the individual that submitted the file is out, then there is a delay in the information being relayed back to correct information that caused a validation error.

Certain organizations have remedied this by creating an end user terminal whereby there is a shared username and password setting for anyone sending files through the eGateway. This approach may not work for some organizations that have policies against this.

There is also an ESG profile that can be set up and the use for it may need further exploration.

Follow up with FDA: If an SPL file was submitted and is not posted to DailyMed, contact SPL@fda.hhs.gov and provide information to track the submission to see if there are validation issues.

 There have been some postings to DailyMed in SPL release 3 that are inconsistent with what some sponsors have sent. This is creating an issue when release 4 submissions are made as they are not consistent with what is currently in the system. These are coming back as validation errors and intervention from FDA is needed to get them to pass. For the interim, contact SPL@fda.hhs.gov and provide information to track the submission. Follow up with FDA will be needed.
 * 2. SPL Conflicts with Posted DailyMed R3 :**


 * 3. eGateway Setup:**

If sponsors have not set up accounts, there has been an increase in the number of new account requests. This has resulted in some delays but a fresh account setup should typically take approximately two weeks. Please account for this in your planning.

Labeler Code requests are needed along with Establishment registration in order to drug list a product. Even though the validation for Establishment Registration is temporarily shut off, the Labeler Code request is still needed. For initial requests where a new Labeler code is assigned to an organization, the typical wait time to receive the number is about 30 to 90 days. Appropriate planning for this should be taken into account.
 * 4. Labeler Code Requests:**


 * 5. Next meeting - Aug 5, 2009 at 1 PM Eastern Time.**