What is Structured Product Labelling (SPL)?
Structured Product Labelling (SPL) is a labelling format based on XML and Health Level Seven (HL7) SPL standards and controlled vocabularies. Regulatory agencies such as Health Canada and FDA, define SPL rules and regulations for labelling compliance.
Health Canada & Mandatory XML PM Labelling
Health Canada is transitioning to the eXtensible Markup Language (XML) Product Monograph (PM) format for drug labeling. This new change applies to new and existing Product Monographs. To partner with AXSource, participate in Health Canada’s XML PM pilot program, and obtain our preferred client rate, please contact us at info@axsource.com.
What is the XML Product Monograph?
On April 10, 2019, Health Canada published a Notice of Intent to transition Product Monograph (PM) labeling to a new structured format based on XML, Health Level Seven (HL7) SPL standards, and controlled vocabularies, collectively termed the XML PM. To learn more, check out our Frequently Asked Questions – XML PM.
Are you ready?
- To comply with Health Canada labelling regulations.
- To convert existing and new Product Monographs to a structured XML format for Health Canada.
- Submit compliant XML PMs.
AXSource can help you:
- Prepare structured labelling in Health Canada’s XML PM format (starting today) using structured product labelling software.
- Review labelling compliance.
- Perform XML PM label validation.
- Submit XML PMs electronically to Health Canada.
- Manage lifecycle changes.
For a quote on structure labelling services for Health Canada, contact info@axsource.com.
United States FDA & Structured Product Labeling (SPL)
AXSource offers the following services in Structured Product Labeling (SPL) for submission to the United States FDA:
- Prepare Structured Product Labeling (SPL) using structured product labeling software
- Review labeling compliance
- Perform SPL validation
- Submit SPL FDA label
For a quote on SPL labeling services for United States FDA, contact info@axsource.com.
Please consult our website for information on additional regulatory services, including eCTD publishing.
FAQs – XML PM & SPL
1. When can we start transitioning to the new XML PM format?
XML PM labelling can be submitted to Health Canada today. For more information on AXSource XML PM services or to participate in Health Canada’s pilot programme, please contact info@axsource.com today.
2. What are the benefits of XML PM labelling?
XML PM will improve the searchability of Product Monographs. Since the new format is more machine readable, it will be easier to index and search information on drug products. The use of controlled vocabularies will improve consistency across all drug products and product monographs. The XML PM format also provides an opportunity to enable other advances in healthcare technology, such as electronic prescribing, automation and mobile applications.
3. What do I need to prepare Product Monographs in the new XML PM format?
XML PM labelling is based on Extensible Markup Language (XML), Health Level 7 (HL7) standards and controlled vocabuarlies. In order to prepare PM labelling in this format, regulatory expertise and experience in the use of specialized structured product labeling software to prepare XML PMs is needed. This process includes performing validation testing and submission to Health Canada.
4. What about other product labels?
Currently, XML structured labelling only applies to Product Monogrpahs (PMs). Immediate product labelling does not need to meet structured format requirements for Health Canada.
In contrast, US FDA does require structured labeling requirements (SPL) be met for all product labelling.
5. Which regulatory product types must meet XML PM requirements?
Currently, XML PM labelling will be required for human drug products.
6. Will this change only apply to new Product Monographs?
Product Monograph labelling in XML PM format is expected to apply to both existing and new Product Monographs.
7. Does this only apply to regulatory submission in eCTD format?
No. This change will apply to regulatory activities submitted in eCTD (Electronic Common Technical Document) format.
8. When will Health Canada require mandatory use of the XML PM format?
Health Canada began consulting stakeholders on XML PM labelling in early 2019. Currently, XML PMs may be submitted on a voluntary basis through Health Canada’s pilot programme. A definitive date for mandatory use of XML PM has not been set.
10. Why is structured product labelling (SPL) important?
SPL ensures that product labeling information is standardized, accurate, and easily accessible. This is crucial for regulatory compliance, improving patient safety, and facilitating efficient data exchange between pharmaceutical companies and regulatory authorities.
11. What types of submissions require SPL?
SPL is required for various submissions, including:
- Drug establishment registration
- National Drug Code (NDC) labels
- Drug listing information
- Content of labeling
- Risk Evaluation and Mitigation Strategies (REMS)
- Lot distribution reports
12. What are the benefits of using structured product labelling software?
SPL software helps streamline the creation, validation, and submission of SPL-compliant documents. Benefits include:
- Ensuring compliance with regulatory requirements
- Reducing manual errors
- Improving efficiency and accuracy in data submission
- Facilitating updates and version control
13. How does structured product labelling (SPL) software ensure compliance?
SPL software typically includes validation tools that check the XML files against FDA standards and guidelines. This ensures that submissions are compliant and reduces the risk of rejection by regulatory authorities.
14. Are there any specific SPL services available?
Yes, SPL services can include:
- Authoring and revision of SPL documents
- Validation and submission of SPLs
- Management of drug establishment registration and listing
- Handling of REMS and lot distribution reports
15. What is the future of structured product labelling (SPL)?
The future of SPL involves continuous updates to meet evolving regulatory requirements and the integration of new technologies to enhance data management and accessibility.
