Health Canada Regulatory Submission Project

The Regulatory Affairs Capstone provided an opportunity to apply concepts developed throughout the Regulatory Affairs program to practical regulatory submission scenarios. Working collaboratively as a team, we developed draft submission packages for two health product projects: Acetaminophen 500 mg Tablets and Sativex Oromucosal Spray.

Acetaminophen 500 mg Tablets

Regulatory Objective

The Acetaminophen project focused on a proposed shelf-life extension from 24 months to 36 months, an associated label update, and notification of DIN discontinuation.

Key Submission Components

  • Cover letter
  • Administrative information
  • Product information
  • Draft labeling
  • Product monograph
  • Product specifications
  • Supporting quality documentation

Sativex Oromucosal Spray

Regulatory Objective

The Sativex project focused on preparing a structured regulatory submission package for a cannabis-derived pharmaceutical product using an existing approved product as the basis for the academic exercise.

Key Submission Components

  • Cover letter
  • Administrative information
  • Product information
  • Draft labeling
  • Product monograph
  • Product specifications
  • Supporting documentation

My Role

Cover Letter and Product Information Lead

My role focused on preparing and refining the cover letters and product-specific documentation included in the submission packages. This included developing product information, draft labeling, product monographs, and product specifications for the Acetaminophen and Sativex projects.

The role required attention to regulatory terminology, document consistency, Health Canada guidance, and the accurate presentation of product information across multiple submission components.