On February 18, 2017 Health Canada released the Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs for external consultation. This guidance document will ultimately replace the current 1998 Change in Manufacturer’s / Product Name Policy (CMPN). Once finalized, this new draft guidance document would replace the CMPN Policy.
The guidance document clarifies the requirements for eligible drug submissions and applications under the administrative pathway. These are applications that do not contain scientific data, or require regulatory review.
Types of applications that are covered under the guidance document include:
- Changes to Manufacturer Name
- Changes to Product Name
- Changes in Product (DIN) Ownership
- Licensing Agreements between two Manufacturers
The guidance document has some great pointers to assist applicants in figuring out which changes are eligible under the administrative pathway, the roles and responsibilities of manufacturers, including those of licensors and licensees, and submission and document requirements for various business arrangements.
There’s even some guidance on how long Health Canada expects the phase-in period for new labelling to exist, which is often a challenge with buy-outs, mergers and cross-licensing agreements.
For more information consult the following link: