The NIIM has made an announcement on changes to the AP approval process with the following implications:
- Brand-based HREC approvals will move to schedule-based approvals
- Via an amendment form, healthcare professionals will be able to switch to the new system
Inter alia, the announcement reads:
- “The TGA would accept ethics approvals for medicinal cannabis products according to the TGA Schedule of the products, rather than each product’s trade name.”
- “The NIIM HREC will accept schedule-based APS ethics applications.
This is welcome news for the industry as it minimises bureaucratic hurdles for prescribers, opening up a wider range of products for cannabis patients.
For the full announcement, please follow this link: https://lnkd.in/gXKShqKm
! Disclaimer: With very few exceptions, medicinal cannabis is not an approved medicine in Australia and the TGA has not assessed them for safety, quality or effectiveness. Speak to your doctor to see whether medicinal cannabis is right for you. For regulatory approved information, please visit https://lnkd.in/gf9_B79