As per the United States Food and Drug Administration (USFDA) and Health Canada norms, adopting technology, it’s processing, managing, labeling, and details of any label changes made, including changing the content of the formatted label and the carton labeling or container labeling, have to be electronically submitted using the Structured Product Labeling (SPL) and Structure Product Monogram (SPM).
Structured Product Label
Structured Product Labeling (SPL) is a Health Level Seven (HL7) standard based on Clinical Document Architecture and the HL7 Reference Information Model (RIM) accredited by the American National Standards Institute (ANSI) for the exchange of product information. Structured Product Labeling or SPL documents include a header and body. The header includes information about the document such as the type of product, its author, and details about its versioning. The body of the document includes product information in both structured text and data element formats. The FDA uses SPL documents to exchange information elaborating upon various product-related topics.
Structured Product Monograph
In 2016, Health Canada announced that the SPL will be considered a Structured Product Monograph (SPM), and it should be submitted in an electronic format. Ensuring the same, the Agency has released guidelines and made it a mandate to submit SPM by Spring 2021. Health Canada adopted the HL7 Structured Product Labeling (SPL) standard for its product monograph submissions and it has even come up with pilot projects.
To assist Life Sciences organizations, Freyr integrates a web-based tool that automates compliance with the current SPL and PLR standards as established by the FDA, and SPM standards for SPL submissions as established by the Health Canada in Health Canada product monographs. Freyr has already started working with Health Canada on several pilot SPMs and ensured all controlled vocabularies and validations have been included in the tool. Currently, Freyr supports six (06) of the templates which have been released by HC with a web-based, comfortable interface that does not require any add-ons.
The SPL Submission Process:
Structured Product Labeling (SPL) & Structure Product Monogram (SPM) is the mandatory document markup standard for Regulatory submission of label content, product and facility information, and any subsequent changes to an existing label information in an electronic format. SPL-SPM format defines the structure and content of label information as required by the United States Food and Drug Administration (US FDA) and Health Canada. The US FDA has mandated SPL requirements for over 50 types of documents, and HC has mandated SPM requirements for over 6 types of documents.
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