HL7 Version 3 Standard: Structured Product Labeling Release 8

DESCRIPTION

SPL release 8 (normative) is a fairly minor extension of the previous releases of SPL, that all received extensive use in production, especially the releases 1, 3, 4, 5 (DSTU and Normative), 6, and 7. In addition to labeling submissions, SPL has been used since 2009 for registering and listing of all drug products legally marketed in the US. Beginning in 2014, Medical Device Labelers will be required to submit device identification information for medical devices commercially distributed in the US. These requirements can be met using submissions that have been formatted in the SPL standard.

The impetus for SPL Release 8 and CPM Release 4 comes primarily from the EMA adoption of IDMP, during review of updated requirements and comparison between the IDMP conceptual model and SPL/CPM found a small number of necessary updates.

Specific changes:

• Structured Product Label Document (PORP_RM050032), adding the RelatedDocument code in order to specify the type of related document in addition to the document id and set id, etc.
• Adding the A_Characteristic and A_SpatialCoordinate CMETs to all the AssignedEntity roles (used for labelers and establishments) in the DMIM POCP_DM030000 (ProductEstablishment) and all the CMETs derived from it. This was required to add specific coded annotations about Establishments and to specify their geographic coordinates.
• A technical correction in POCP_DM040000 (ProductEvent) where the description of one of the recursive component relationship was incorrect, implying the inverse of what was described in the definition. This has been corrected by adding both direction (component to composite, to specify that this product event is part of a greater activity, and composite to component to decompose the product event into smaller steps.)
• Adding a custodian participation from the Document in POCP_DM050000 (ProductInformation) with the meaning of a physical custodian of a physical document (such as, the adverse event master file).

 

 

ALTERNATIVE NAMES

HL7 Version 3 Standard: Structured Product Labeling Release 8 may also go by the following names or acronyms:

TARGETS

• Regulatory Agencies
• Pharmaceutical Vendors

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.

RELATED DOCUMENTS

HL7 Version 3 Standard: Structured Product Labeling Release 8

(Download)

TOPIC

• SPL

BALLOT TYPE

• Normative

STATUS DATE

2017-02-03

RESPONSIBLE WORK GROUP

STAKEHOLDER

• Pharmaceutical Vendors

FAMILY

• V3

CURRENT STATE

• Stable

REALM

• Universal