Consultation on updates to sections of drug and natural health product documents
Drug Establishment Licensing Bulletin #169, March 1, 2024
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About the consultation
Health Canada is seeking feedback on select sections of the following revised documents:
- Drug and natural health products recall guide (GUI-0039)
- Drug and Natural Health Product Recall Reporting Form (FRM-0356)
- Annex 2 to the Good manufacturing practices guide – manufacture of biologics (GUI-0027)
- Annex 3A to the Good manufacturing practices guide, Schedule C drugs (GUI-0026)
The consultation period is from March 1, 2024, to March 22, 2024.
We have updated the guides and form to reflect upcoming changes to the Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licenses and Finished Product Testing).
We're currently analyzing comments received during the previous consultation of GUI-0027 and GUI-0026. We'll consider all of them in the final version of the guidance documents.
Overview of key changes
We're making regulatory changes that modernize Health Canada's regulatory post-market oversight of therapeutic products. With this in mind, we've made the following changes:
- GUI-0039: Clarify regulatory requirements when conducting recalls of drugs and natural health products, including reporting requirements for product recalls
- FRM-0356: Changes to reporting requirements for product recalls
- GUI-0027: Changes to finished product testing requirements for biologic drugs
- GUI-0026: Changes related to the direct shipment of radiopharmaceuticals
How to participate
Email us to ask for the consultation package and to submit your comments by March 22, 2024. We'll consider all comments when we finalize the guidance documents.
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