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. They are also mandated for various types of products including human prescription/Standard template at HC 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 SPL-SPM format that are supported by the US FDA and Health Canada 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
- Bulk ingredient
- Human Compounded drug label
- Human OTC
- SPL/Content of Labeling(CoL)
- Master Template
To submit drug labels through an SPL-SPM 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 SPL-SPM 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 aligning with SPL and SPM standard Control Vocabularies and company & product information.
Freyr SPL-SPM 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-SPM Software reduces time taken for implementation and will sure be a cost-effective solution, for your SPL-SPM submissions.
As Health Canada started accepting XML product monographs on a “by request” basis, 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
Freyr SPL Features
- Automation of a Label Document
- Structured Product Labeling (SPL) and Structured product monogram supporting document repository
- Generation of both word track and clean copy for place at eCTD structure
- SPL version management
- Multiview availability: SPL, XML, content editing, word
- 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 SPL-SPM 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