Electronic Drug Registration and Listing Instructions
Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label Distributors).
As of June 1, 2009, FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. Moving from a paper-based format to an electronic system will improve the timeliness and accuracy of the submissions. Please click here for more information (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm078801.htm)
SPL Starter Package
(http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM174434.zip) The SPL Starter package is designed to assist new SPL authors with accessing and using SPL Xforms for creating their Drug Registration and Drug Listing documents. The package includes: step-by-step instructions for using SPL Xforms, the SPL Xforms software, and a link to SPL authoring tool vendors, conversion services, etc.
Additional SPL resources
The following "road map" document has interactive links to assist you in learning the process for creating and submitting SPL documents. (http://spl-work-group.wikispaces.com/file/view/roadmap_creating_and_submitting_spl_R4.pdf)
Please click here for additional SPL resources (http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm2005542.htm). Questions regarding SPL submissions and content should be directed to: email@example.com
Check Status of the Drug Establishments
To check the status of the “Drug Establishments”, firms can check the Drug Firms Annual Registration Status website accessible via this hyperlink: http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm.
Obtaining an Electronic Submissions Gateway (ESG) account
The following checklist will provide guidance for setting up an account with the FDA Electronic Submissions Gateway (ESG) for the purpose of submitting Drug Registration and Drug Listing using Structured Product Labeling (SPL).
|Request a WebTrader account|
|1. Send an email to firstname.lastname@example.org requesting a WebTrader test account. Provide the following information: Company name, your name, phone number and submission method (WebTrader). Click here for more information on the email policy.|
|2. Send a Letter of Non-Repudiation to FDA. Click here for more information on Non-Repudiation Letters.|
Click here for additional steps pertaining to CROs, US Agents and Consultants.
|3. Obtain a personal digital certificate. Click here for more information on certificates.|
|4. Prepare a guidance compliant test submission. Please refer to the Structured Product Labeling Resources page for more information on how to prepare SPL documents. On this page under the 'Resources' section is the 'SPL Starter Package' that walks you through the process for creating a submission. FDA recommends creating an 'NDC Labeler Code Request' SPL document as your test submission.|
|5. Read the User Guide and tutorials on the FDA ESG website. Review System Requirements. Note: only Internet Explorer 6, 7, 8, and 9 are compatible with ESG.|
|Register Your Test Account|
(for technical assistance contact ESGHelpDesk@fda.hhs.gov)
|Wait for email with information on how to register online for a WebTrader test account. (reply to email from Step 1)|
|6. Register for a WebTrader test account. Follow the steps outlined in the email and refer to "Registering for a web based test account" tutorial for detailed registration steps. You will need the public key for your personal digital certificate (refer to step 3) to complete this step. Note: The Primary Contact must be a real person; the "Company Name" is actually an account name and must be unique throughout the entire ESG test system. We recommend appending the user's initials to your company name.|
|Wait for the WebTrader test account activation email. Account activation may take up to 48 hours.|
|Setup your machine/PC for ESG|
|7. Activation email received. Follow the instructions outline in the email to:|
|a. Install JRE and JCE. JRE and JCE Installation Instructions.|
|b. Configure your firewall (activation email will contain the details)|
|Send Test Submissions|
|Log in to your ESG WebTrader test account (same URL to Register for a test account) with the user ID and password you created when you registered for your test account (step 6 above).|
|8. Send a small (20KB) text (.txt) file to the "Testing (GWTEST)" center with submission type "Connectivity Test". Refer to "sending a test submission" tutorial for detailed steps.|
|9. Send a guidance compliant test submission to ‘OC’ center with submission type ‘SPL’. See step 4 above for more information.|
|The FDA will review your guidance compliant test submission, which may take up to 2 weeks. You will be notified by the ESG staff by email regarding submission status.|
|Set Up a Production Account|
|10. Once you have sent all test submissions and the guidance compliant submission meets FDA requirements your account will be migrated to production. You will receive an email from ESG Helpdesk with production account confirmation and production URL|
|Log in to your ESG WebTrader production account with the same user ID and password you created when you registered for your test account (step 6 above).|
|You are now ready to send electronic submissions to FDA using the ESG system.|
Helpful Contact Information
For questions relating to the content of SPL submissions, contact SPL@fda.hhs.gov.
For policy questions and to request a WebTrader account, contact email@example.com.
For technical assistance with the registration or testing process, contact ESGHelpDesk@fda.hhs.gov.