SPL R4

A4L 4.3 NOW AVAILABLE!

This new version 4.3 of A4L delivers full SPL R4 functionality within its easy-to-use features but now incorporated updates to the FDA controlled vocabularies and additional validation lists, moving the application beyond the desktop as it incorporates functionality that is more automatic.

Life Science enterprises can author, submit, validate and manage their labeling process using current ingredient and other controlled vocabulary lists.

Version 4.3 continues to support Human Prescription Drug Labels (HPDL), Human Prescription Drug Labels with Highlights (HPDLH), Veterinary Drug Product Labels, OTC, and Medical Devices along with NDC Labeler Code Requests, Establishment Registration and Listing SPLs as defined in the SPL Guidance Documents.

• A4L's new SPL Updater functionality, which enables validation changes, FDA controlled terminology and UNII Code updates (based on the FDA resource files) automatically, eliminating the need for users to access the FDA web site separately.
• A searchable display of synonyms for UNII Codes is now supported to maximize confirmation and validation of all UNII codes
• Validation process checks for postal codes and all non-US countries.
• New templates and functionality to support new regulatory requirements in the following products:
• Bulk Ingredients
• Kit with Medical Devices with Highlights and Kit with Medical Devices without highlights as added.

What R4 Means to Industry:

With the introduction of SPL R4, an exciting new chapter in the development of the SPL standard has come to fruition.  As of June 1st, 2008 all Labeler Code Requests (LCR), Establishment Registrations (ER), and Content of Labeling will be submitted in SPL form.

Be ahead of the game, contact i4i to find out how you can author, review, and submit all of your SPL R4 content simply and easily, using our A4L platform.
Do not waste time with xForms!

The new SPL R4 standard:

SPL R4 has been officially approved by Health Level 7, and implemented by the FDA.  All establishment registration, product listing and product labeling submissions must be in valid SPL R4 format starting June 2009.

What this means:

Changes have been made to the Content of Labeling SPL (both SPL and SPL with Highlights) to include:

• Marketing information.

• Labeler Codes content

• Manufacturing information.

• Additional drug product information.

·         SPL standard will encompass a new set of document types:

• NDC Labeler Code Request

• Establishment Registration

• Drug Listings

• Biologics Labels

• Veterinary Medicines Labels

Impact to your organization:

• May require new users to access different documents and learn new skills

• May introduce new interaction between departments or business units

• May introduce another department or division that is handling another product type i.e.: Biologics, OTC, Veterinary

• Will produce more types and versions of documents to manage

• Will require more product and company information to be contained within drug labels