Solutions for Canada Manufacturers

At Thinspring, we understand that compliance activities do not exist in a vacuum and that gaps in Regulatory Information Management (RIM) can substantially impact your company's core business processes. To help your company meet these challenges ThinSpring solutions combine the best of Structured Content Authoring (SCA) and Software as a Service (SaaS) technology to provide flexible and responsive submissions solutions.

Health Canada (HC) - Structured Product Monograph (SPM)

The Notice: Phase II of the XML PM Project was initiated in 2021. Health Canada is working on a strategic approach to support the transition of all product monographs into the XML format, which will become a mandatory requirement for product monographs.

In April 2019, Health Canada announced its intent to transition product monograph templates to a structured format based on XML format, Health Level 7 (HL7)'s Structured Product Label (SPL) standard and controlled vocabularies. Beginning June 14, 2021, Health Canada will initiate Phase II: Full Production on a voluntary basis.

Thinspring provides the following services:

• Creation: Our SPM solution will create the required Structured Product Monograph content either using our conversion services or our Software as a Service solutions.
• Conformance: Thinspring will ensure that all products conform to current guidance and validation rules. Health Canada will validate all XML PMs against a defined set of rules to confirm that the XML file is valid and in an expected structure and required data has been provided.
• Submissions: Our submissions gateway services Health Canada so we can provide HC submission services for Structured Product Monographs.

Offering an end to end collaborative service environment for submissions management, ThinSpring delivers a powerful and flexible set of services and tools.