SPM & SPL Labeling

What is SPL?

Structured Product Labeling 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 SPM Labelling

Health Canada is transitioning to Structured Product Monograph (SPM) format for Product Monograph labelling. This new change applies to new and existing Product Monographs. To partner with AXSource and participate in Health Canada’s SPM pilot programme and obtain our preferred client rate, please contact us at  info@axsource.com.

What is the Structured Product Monograph (SPM)?

On April 10, 2019, Health Canada published a Notice of Intent to transition Product Monograph (PM) labelling to a new structured format based on XML, Health Level Seven (HL7) SPL standards and controlled vocabularies, collectively termed the Structured Product Monograph (SPM). To learn more, check out our Frequently Asked Questions – SPM Label.

Are you ready?

  • To comply with Health Canada labelling Regulations
  • To convert existing and new Product Monographs to a structured XML format (SPM) for Health Canada
  • To submit compliant SPMs

AXSource can help you:

  • Prepare structured labelling in Health Canada SPM format (starting today) using structured product labelling software
  • Review labelling compliance
  • Perform SPM labelling validation
  • Submit SPM labelling electronically to Health Canada
  • Manage lifecycle changes

For a quote on SPL 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 – SPM Label

1. When can we start transitioning to the new SPM format?

SPM labelling can be submitted to Health Canada today. For more information on AXSource SPM services or to participate in Health Canada’s pilot programme, please contact info@axsource.com today.

2. What are the benefits of SPM labelling?

SPM 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. SPM 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 SPM format?

SPM 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 SPMs is needed. This process includes performing validation testing and submission to Health Canada.

4. What about other product labels?

SPM labelling currently 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 SPM requirements?

Currently, SPM labelling will be required for human drug products.

6. Will this change only apply to new Product Monographs?

No. Product Monograph labelling in SPM 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) and non-eCTD format.

8. When will Health Canada require mandatory use of SPM?

Health Canada began consulting stakeholders on SPM labelling in early 2019. Currently, SPM labelling may be submitted on a voluntary basis through Health Canada’s pilot programme. A definitive date for mandatory use of SPM has not been set.

9. What does a SPM label look like?

For a structured product labeling example,

Click here

SPL-SPM-labeling example