What is SPL?
Structured Product Labeling is a labeling 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 labeling 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 labeling 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.
Frequently Asked Questions – XML PM
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.
