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 S.A., and that:
1) 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 the Medicines Control Council (MCC) of South Africa (S.A.)
2) the medication will only be supplied to, and used by and on me once specific approval has been obtained from the MCC of S.A.
3) the medication
(country of origin) and that its quality, effectiveness and safety are well documented and within legally and scientifically acceptable levels)
4) appropriate measures will be taken to prevent, monitor and manage the unwanted effects on me of the unregistered medication
5)
(name of doctor) will comply with all regulations of the MCC, laws (S.A. and foreign) and conditions of approval of use of this unregistered medication/device and accordingly ensure continued availability and supply of the medication
6) use of the unregistered medication on and by me is for managing my disease and not for medical research
7) any information collected by
(name of applicant), his/her employer, successor or any other person other that the MCC or its legal representative, may be used for research purposes upon receipt of specific written separate informed consent from me, my guardian or person responsible for my affairs after my death
8) I will be free stop using the medication at any time and that I will inform my (treating) doctor accordingly.
If you agree to these terms please sign (type your name) below:
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