Product SPL IG

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Product Brief - SPL r5 IG

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Product Name - SPL r5 IG

  • HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 5

SPL IG

Type

Informative

Releases

HL7 IG SPL, R4;
Release 4 - January 2009
Release 5 - First ballot May 2010

Summary

The Structured Product Labeling (SPL) specification is a document markup standard that specifies the structure and semantics of the content of authorized published information that accompanies any medicine licensed by a medicines licensing authority. These documents are known as "product label," "package insert," "prescribing information," "product information," "medicines information," and under many other names. The precise definition and content of product labeling usually varies depending on the country. (For example, in the U.S., all written, printed, or graphic matter accompanying a medicinal product is called "labeling." For human prescription drugs, the "content of labeling" includes all text tables and figures in the labeling described in 21CFR 201.57.) Implementers of this standard should refer to regulations, definitions and guidances applicable for the realm in which the standard will be used. Release 5 of SPL is restructured to reference the Common Product Model. Release 5 and the Common Product Model provide for the use of Universal Device Identifiers (UDI).

Description

An SPL document is created by an organization that is required by law to submit product information document because it is responsible for the creation or marketing of a product, or any other person or organization compelled by other motives to submit information about products, whether originally created or not. This includes: original manufacturers, repackagers, relabelers, and public agencies or private information publishers that submit product information documents. Recipients of product label documents are any person or organization, including the public at large, or an agent of the public (such as a regulatory authority). The need to create SPL documents is typically governed by legal statutes which set points such as the completion of a new drug application (NDA), the change of product information or annual reports as requiring submission of an SPL document.

The Implementation guide provides technical conformance criteria for Structured Product Labeling (SPL) files based on the drug establishment registration and drug listing process at the United States Food and Drug Administration (FDA). Information on electronic submission may be found in guidance entitled Providing Regulatory Submissions in Electronic Format – Establishment Registration and Drug Listing.

Additionally, release 5 extends the SPL model to develop a message that will allow transmission of a regulatory product information submission (labelling, listing, registration, unique device identifier and associated attributes as specified by the Global Harmonization Task Force (GHTF) ad-hoc working group on (UDI.) submissions). The standard provides references to other standards and external terminology resources required to populate the data elements defined in the standard.

Business Case (Intended Use, Customers)

The purpose of the SPL specification is to facilitate the review, editing, storage, dissemination of, and access to product labeling document content. It is intended to:

  • Facilitate provision of the content of product labeling both electronically and in a human readable format. SPL documents can be exchanged across systems without the need for additional transformation steps.
  • Improve dissemination of product labeling (both new product labeling and product labeling updates) to users of product labeling. The ability to provide the most up-to-date product labeling in a timely manner is considered to be critical to improving risk management of regulated products.
  • Facilitate more efficient evaluation of labeling changes by allowing more effective use of computer technology to compare different versions of labeling on a section by section basis.
  • Promote more coordinated data collection throughout the regulatory agency and improve processing, storage and archiving capabilities. Reduce or eliminate redundancies in data collection.
  • Improve access to information and enhance the ability to query and report on the content of labeling, allowing better support for specific analyses such as sub-population assessments of differences in products based on gender, race, age, and geographic location.
  • Improve interoperability of the regulatory agency's systems with other clinical information systems
  • Use standards to improve integration of clinical data
  • Enhance patient safety by helping to provide prescribers and consumers with improved access to information needed to make better risk management decisions in a format that will enhance integration with other technical and clinical applications.
  • Support retention of legacy product labeling in databases

User of this standard include

  • FDA,
  • Pharmaceutical Companies
  • Veterinary Drug Product Companies
  • Biologic Drug Companies
  • Producers of bulk drug products
  • Medical Device Companies


Benefits

This standard provides for human readable and machine readable labeling for drug products.

Implementations/ Case Studies (Actual Users)

More than 5000 FDA approved labels (package inserts) can be found at the DailyMed website

Resources

Work Groups

Relationship to/ Dependencies on, other standards

  • SPL is a sibling to CDA

Links to current projects in development

  • none