Overview

Structured Product Labeling (SPL) 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 format defines the structure and content of label information as required by the United States Food and Drug Administration (US FDA),Center for Biologics Evaluation and Research(CBER) and Center for Drug Evaluation and Research(CDER).The FDA has mandated SPL requirements for over 50 types of documents and various types of products including human prescription drugs(labeling of pharmaceutical products, biological and generic drugs), over-the-counter (OTC) products, veterinary medicine, homeopathic products, bulk ingredients, etc. Some of the common document types that are supported by FDA SPL standard are listed below:

  • Blanket No Changes Certification of Product List
  • Establishment Registration
  • National Drug Code (NDC) Labeler Code
  • Lot Distribution Data SPL
  • Drug Listing SPL
  • SPL / Content of Labeling(CoL)

To submit drug labels through an SPL compliantly, applicants must have a deep understanding about the compilation of submissions in XML format to avoid errors that causes reworks viz. incomplete data, section misalignment, improper hyperlinking, etc. To overcome such procedural complexities, Freyr Structured Product Labeling (SPL) software – compliant with 21 CFR Part 11criteria and Health Level Seven (HL7) standard – offers a robust platform to create, validate, store, and submit complex content structures, SPL Standard data elements and company and product information.

Freyr SPL software is stacked with enhanced features such as electronic records, electronic signatures, etc. making it secure and reliable. Being offered both on cloud and on-premise models, Freyr SPL Software reduces time taken for implementation and will sure be a cost-effective solution, for your SPL submissions.

As Health Canada started accepting XML product monographs on a “by request” basis from April 1, 2020 to July 31, 2020, Freyr has started supporting large international drug product manufacturers. Below are a few key notes with regards to the mandate and steps to establish and test the SPM program.

  • Sponsors can submit a request to file XML product monographs, in the 2016 format, under the following submission types:
    • New Drug Submissions (NDS) Where a Canadian Reference Product files in the 2016 format
    • Abbreviated New Drug Submissions (ANDSs) and Supplements to Abbreviated New Drug Submissions (SANDSs) can also file in the XML format
    • Supplements to New Drug Submissions (SNDS), where changes are proposed to format or content of the product monograph
    • All subsequent submissions of a product already filed in the XML format, are also required to continue filing in XML format

The transition period has been established, so that both the Health Canada and industry systems are in place for the full launch scheduled for the Fall 2020. Health Canada plans to make the XML format a mandatory requirement by the Spring 2021.

 

Freyr SPL Expertise

  • Dashboards and Reports

  • SPL Request Status Track

  • SPL Request Initiation

  • Authoring SPL

  • SPL Validation

  • Reviewing SPL

  • Version the SPLs

  • Approve SPL

 

Freyr SPL Features

  • Structured Product Labeling (SPL) supporting document repository
  • SPL version management
  • Multiview availability: SPL, XML, content editing, pdf
  • Workflow management and parallel review
  • Administration of users, roles, FDA SPL data elements, company and products information
  • Robust and user-friendly web interface
  • Email notifications to task owners and annual updates’ notifications
  • Open architecture integrated with leading document management system (DMS)
  • On-premise and cloud hosting deployment of Structured Product Labeling software
  • Text comparison
  • Revision of the existing SPLs
  • Bulk SPL data migration at the time of client site hosting
  • Supports 21 CFR Part 11compliance (eSignature, audit trails, etc.)
  • Compliant with HL7 SPL specifications
  • Reduces manual effort of editing in XML

To Know More about Freyr SPL software and to take a feature-specific comprehensive product tour.

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