Section 1e: Version 3 (V3)
Section 2: Clinical and Administrative Domains

HL7 Version 3 Standard: Structured Product Labeling, Release 6

DESCRIPTION

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."

ALTERNATIVE NAMES

HL7 Version 3 Standard: Structured Product Labeling, Release 6 may also go by the following names or acronyms:

"HL7 Version 3 Standard: Structured Product Labeling (SPL), Release 6", SPL

TARGETS

  • Regulatory Agency
  • Standards Development Organizations (SDOs)
  • Pharmaceutical Vendors
  • EHR, PHR Vendors
  • HIS Vendors
  • Local and State Departments of Health
  • Healthcare Institutions (hospitals, long term care, home care, mental health)

 

BENEFITS

  • Enables the content of labeling and the data structures from the Common Product Model (CPM), where data structures from the CPM and the XML schema encoding them have been in use since the early 2000s, and particularly since 2009 for registering ("listing") all drug products legally marketed on in the US
  • Supports the US FDA in using the CPM for listing medical devices in the Global Unique Device Identification Database.
  • Provides the content of labeling which has also been in use since the early 2000s, providing labeling content for drug and biologic products
  • Supports the implementation of the FDA’s Risk Evaluation and Mitigation Strategies (REMS).

IMPLEMENTATIONS/CASE STUDIES

  • Thousands of US domestic, non-US (international), and multi-national companies, small and large are submitting their medical product information in the SPL format

RELATED DOCUMENTS

HL7 Version 3 Standard: Structured Product Labeling, Release 6
HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 1 (View Brief)

(Download) (895 KB)

HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 3: FDA Content of Labeling (View Brief)

(Download) (232 KB)

HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 4 (View Brief)

(Download) (235 KB)

HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 5 (View Brief)

(Download) (262 KB)

HL7 Version 3 Standard: Structured Product Labeling, Release 1 (View Brief)

(Download) (2.72 MB)

HL7 Version 3 Standard: Structured Product Labeling, Release 2 (View Brief)

(Download) (3.78 MB)

HL7 Version 3 Standard: Structured Product Labeling, Release 3 (View Brief)

(Download) (2.25 MB)

HL7 Version 3 Standard: Structured Product Labeling, Release 4 (View Brief)

(Download) (3.66 MB)

HL7 Version 3 Standard: Structured Product Labeling, Release 5 (View Brief)

(Download) (241.41 MB)

Structured Product Labeling (SPL) in the Clinical Environment - Presentation (2010) (View Brief)

(Download) (3.85 MB)

ADDITIONAL DETAILS

This standard is available in the HL7 2015 Normative Edition. The 2015 Normative Edition is also available online to members.

TOPICS

  • Materials Management
  • Pharmacy
  • Regulated Products
  • SPL

BALLOT TYPE

  • Normative

STATUS DATE

2015-09-09

RESPONSIBLE WORK GROUP

Biomedical Research and Regulation

PRODUCT TYPE

  • ANSI-approved

STAKEHOLDERS

  • EHR, PHR Vendors
  • Healthcare Institutions
  • HIS Vendors
  • Local and State Departments of Health
  • Pharmaceutical Vendors
  • Regulatory Agency
  • Standards Development Organizations (SDOs)

FAMILY

  • V3

CURRENT STATE

  • Retired

REALM

  • Universal