Freyr SPL - SPM

The compliance environment for pharmaceutical and biotech companies operating in Canada is shifting in meaningful ways. Health Canada has announced a critical change in submission requirements that will significantly impact how pharmaceutical, biologic, and radiopharmaceutical products are submitted and maintained. Effective July 18, 2025, certain submission types must include product monographs in the new Structured Product Labeling format known as XML Product Monograph (XML PM).

Ever wondered about the drug labels and what goes into creating the content for it? Of course it serves the purpose of providing information about the ingredients, usage and what the medication is used for but how do health authorities standardize the content structure for it? The answer is SPL (Structured Product Labelling) and SPM (Structured Product Monograph). While the two names might sound similar, they serve different purposes in the world of medicine.

Structured Product Labeling (SPL) and Structure Product Monograph (SPM) are the mandatory document mark-up standards for the submission of label content, product and facility information and any subsequent changes to the existing label information in an electronic format. SPL format defines the structure and content of label information as per the United States Food and Drug Administration (US FDA), whereas SPM is for Health Canada (HC).