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

HL7 Version 3 Standard: Structured Product Labeling, Release 7 (SPL R7)

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 or device licensed by a regulatory 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 7 (SPL R7) may also go by the following names or acronyms:

HL7 Version 3 Standard: Structured Product Labeling (SPL) R7, , SPL R7

TARGETS

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

BENEFITS

SPL is comprised of two main components: the content of labeling and the data structures from the Common Product Model (CPM).  The 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. The FDA is now using the CPM for listing medical devices in the Global Unique Device Identification Database. The content of labeling has also been in use since the early 2000s, providing labeling content for drug and biologic products.

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.

DEVELOPMENT BACKGROUND

SPL is comprised of two main components: the content of labeling and the data structures from the Common Product Model (CPM).  The 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. The FDA is now using the CPM for listing medical devices in the Global Unique Device Identification Database. The content of labeling has also been in use since the early 2000s, providing labeling content for drug and biologic products.

RELATED DOCUMENTS

HL7 Version 3 Standard: Structured Product Labeling, Release 7 (SPL R7)

(Download) (121.82 MB)

TOPICS

  • Materials Management
  • Pharmacy
  • Regulated Products
  • SPL

BALLOT TYPE

  • Normative

STATUS DATE

2016-04-28

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