Awaken

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Section 21 Consent

I voluntarily agree to be treated with a medication namely < 1% Delta-9-Tetrahydrocannabinol which is not registered in South Africa.

I confirm that I have been fully informed and my questions answered about my disease (for which a section 21 application is being made), its cause, severity, prognosis, available (in South Africa) registered treatment options and the reasons for the current state of my illness and the unregistered medication and application to use a medication that is not registered in South Africa and that:

  • the medication is not registered in South Africa) and that this implies that the quality, effectiveness and safety of this medication have not been verified by SAHPRA.
  • the medication will only be supplied to and used by and on me once specific approval has been obtained from SAHPRA.
  • appropriate measures will be taken to prevent, monitor and manage the unwanted effects on me of the unregistered medication.
  • use of the unregistered medication on and by me is for managing my disease and not for medical research.
  • I will be free stop using the medication at any time and that I will inform my (treating) doctor accordingly.