Self-Care Products Framework
Subject
Health Canada’s new Self-Care Products Framework proposes a modernized framework for regulating self-care products including cosmetics, NHPs, and OTC drugs. Unlike the current system which includes 3 different sets of onerous and inconsistent regulations administered under two branches of government, the framework proposes a risk-based and consistent approach to the regulation of self-care products.
Objective
Our goal is to achieve a level-playing field for all self-care products where low-risk cosmetic-like drugs and NHPs are classified with cosmetics in the lowest risk tier with appropriate oversight (i.e. no requirement for pre-market authorization or licensing). Ultimately, this will reduce regulatory burden, minimize cost, and simplify getting products to market in Canada for our members.
Strategy
CA’s strategy includes working with Health Canada to develop the operational details of the framework and advance the regulatory amendments and legislative reforms required to enable the framework, as well as building political and public support for the new framework by engaging with stakeholders including elected officials and senior bureaucrats.
CA Participates in NNHPD Multilateral; CA Team Advocate Self-Care Framework
CA Meets with New Deputy Minister of Health; Opportunity to Introduce our Industry and Priorities
Stakeholders Meet With New Deputy Minister of Health
CA Letter to Health Canada Deputy Minister – Self-Care & Request for Further Interim Relief
Cost Benefit Analysis Survey Webinar Slides
Performance Standard for the Fees in Respect of Drugs & Medical Devices Order
Webinar on Revised Fees for Drugs & Medical Devices
Plain Language Labelling Compliance Plans – Request from NNHPD
Adverse Reaction Reporting Notice