Anavex Life Sciences Corp (AVXL)

[Gernee20]

I thought the following information from the TGA website was interesting regarding the reporting to the TGA of the unapproved medicine being prescribed. Bold is mine

About Authorised Prescribers
Authorised Prescribers are medical practitioners who are approved to prescribe unapproved therapeutic goods for a particular condition or class of patients in their immediate care without further TGA approval.

To become an Authorised Prescriber the medical practitioner must:

have the training and expertise appropriate for the condition being treated and the proposed use of the product
be able to best determine the needs of the patient
be able to monitor the outcome of therapy.
An Authorised Prescriber is allowed to supply the product directly to specified patients under their immediate care and not to other practitioners who prescribe/administer the product. Use of the product under an authorisation must be at all times in line with the conditions specified in the authorisation.

Once a medical practitioner becomes an Authorised Prescriber they do not need to notify the TGA each time they prescribe the unapproved product during the period of approval, however they must report to the TGA the number of patients treated every six months. Use of the product must be reported twice yearly covering each period between 1 January to 30 June and 1 July to 31 December within one month of that period ending. Please use this template for six monthly reporting: