Annex 7 to the good manufacturing practices guide - selected non-prescription drugs (GUI-0066)
Drug Establishment Licensing Bulletin 135, September 29, 2023
On September 29, 2023, the Health Product Compliance Directorate posted the following annex to the Good manufacturing practices guide for drug products (GUI-0001):
Annex 7 applies to non-sterile, selected non-prescription drugs from a recognized country or region. It will help you to apply the recent regulatory changes made under the Canada-United States-Mexico Agreement (CUSMA).
This guide replaces the August 2020 version. It's based on the pharmaceutical inspection cooperation scheme (PIC/S) document:
Key changes to the revised document include:
- revised wording in the personnel section (C.02.006) concerning practical experience:
- makes the wording clearer
- aligns with the following Health Canada guidance documents:
- Annex 4 to the Good manufacturing practices guide - veterinary drugs (GUI-0012) and
- Good manufacturing practices guide for drug products (GUI-0001)
- revised wording in the stability section (C.02.028)
- keeps previous flexibilities
- aligns with the level of risk associated with these products
- alignment with the PIC/S guidance
- inclusion of a note, in the introduction section, clarifying that although antiseptic skin cleansers intended for personal use in a commercial or institutional setting (e.g. workplaces, washrooms in public buildings), or for professional use in food-handling premises or in healthcare settings (e.g. hospitals, nursing homes, clinics, dental offices) are excluded from the monograph, these products will still be subject to interpretations of this guide and any associated regulations.
Contact us
If you have questions we invite you to contact the Health Product Inspection and Licensing Division of the Regulatory Operations and Enforcement Branch. Email us at drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca.