Health Canada has launched Phase 1 of the implementation of the Self-Care Framework with the “pre-publication” in Canada Gazette Part 1 of a proposal to amend the Natural Health Product Regulations with respect to labelling.
CA is very supportive of the launch of Phase 1 as it represents the first step towards finally implementing the Self-Care Framework which is a major and much needed regulatory modernization initiative for the cosmetics and personal care products industry! The Framework will treat “like” products (whether they be cosmetics, drugs, or natural health products) the same, regulating them commensurate with their safety/risk profile. A copy of our public statement as well as the Government’s News Release and related Guidance documents can be found below.
The proposal, issued June 25 and open to public comments for 70 days, is intended to deliver upon the government’s long- standing commitment to improve labelling for health products while ensuring the alignment of labelling requirements for similar risk products within the Self-Care Framework. Implementation of Phase 2 of the Framework, which will include the further regulatory and legislative changes required for the overall Framework, is expected to be launched in the Spring of 2022.
Based upon the experience of the labelling modernization for non-prescription drugs, the government has recognized the need to allow for innovative digital labelling options to accommodate new requirements while avoiding increased package sizes as well as having a long implementation period so label changes can occur within the normal life cycle of a product’s label. Both of these considerations have been advanced and supported by CA.
CA’s Product Compliance & Market Access (PCMA) and Facility Compliance & Manufacturing (FCM) Committees are reviewing the proposal and will provide input to shape CA’s written submission on behalf of our industry. Our comments will include the need to expand the use of digital labels, such as SmartLabel, and allow for suitable implementation periods.
CA’s STATEMENT:
CA Statement – Self-Care Framework Phase 1 Implementation – June 25 2021
CANADA GAZETTE PART 1:
https://gazette.gc.ca/rp-pr/p1/2021/2021-06-26/html/reg4-eng.html
HEALTH CANADA NEWS RELEASE:
GUIDANCE DOCUMENTS:
DRAFT Guidance Document Labelling of Natural Health Products
DRAFT Homeopathic Evidence June 25
ÉBAUCHE – Document de référence Étiquetage des produits de santé naturels
