As per the United States Food and Drug Administration (USFDA) and Health Canada norms, adopting technology, its processing, managing, labeling and details of any label changes made, including changing the content of the formatted label and changing the carton labeling or container labeling have to be electronically submitted using Structured Product Labeling (SPL) and Structure Product Monogram (SPM).

Structured Product Label (SPL) Format

Structured Product Labeling (SPL) is a Health Level Seven (HL7) standard based on Clinical Document Architecture and HL7 Reference Information Model (RIM) accredited by the American National Standards Institute (ANSI) for the exchange of product information. 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 (SPM) Format

In 2016, Health Canada announced that SPL will be considered as 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 the Spring 2021. Health Canada adopted the HL7 Structured Product Labeling (SPL) standard for its product monograph submissions and it has even came up with pilot projects.

To assist organizations, Freyr integrates a web-based tool that automates compliance with current SPL and PLR standards as established by the FDA and SPM standards as established by the Health Canada. Freyr has already started working with the Health Canada on several pilot SPM’s and made sure of all controlled vocabularies and validations included in the tool. currently Freyr supports 6 of the templates which has been released by HC by comfortable interface and web based and with no add-ons required. 

The SPL Submission Process:

Structured Product Labeling(SPL) Submission Process, USFDA


Freyr Expertise

  • Comprehensive SPL-SPM  conversion services to handle all types of products including prescription drugs, OTC products, scheduled drugs, veterinary medicine, homeopathic products, and bulk ingredients as well as experts to dispatch and publish to health authority
  • Implementation of all templates with controlled vocabulary released by respective health agencies
  • Managing, recognizing, and resolving the errors made while publishing both SPL-SPM formats
  • Tackling registrations like NDC Labeler, bulk ingredient & Establishment Registration etc.
  • Drug Labeling, Listing, and other Drug Product Submissions
  • Content-of-Labeling for prescriptions (Human and Animal) Drug Label, OTC, BLAs
  • Validation of SPL-SPM submissions and successful publishing of the error-free labeling content as per the health authority guidelines.
  • Identifying and defining a flexible delivery plan that can withstand last minute updates
  • Conversions of both French and English formats for SPM
  • Comparison of text in two different versions to match the label documents

Freyr Advantages

  •  A project brief that clearly outlines the individual roles and responsibilities, dependencies and other critical aspects for project success
  • Communicating   project expectations both at the beginning of the project during the “starting up” project phase and at regular intervals during the delivery phase, as well and periodically during the delivery phase
  • Continuous project monitoring and immediate resource ramp up from the rolling bench
  • Proactive training and system access for resources on the bench

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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