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Therapeutic Goods Administration relaxes the requirements on nicotine as an unregistered medicine

Updated: Mar 8, 2022

The Therapeutic Goods Administration (TGA) has relaxed requirements on Nicotine as an unregistered medicine by making 'Authorised Prescriber' status for doctors just a matter of filling a form on the TGA web portal and receiving Authorisation in 24 hours. This decision paves the way for other novel medicines to be treated in a similar manner.


The TGA have also authorised SAS-B applications for psilocybin and MDMA and the Victorian and WA state governments have issued Schedule 9 licences to manufacturers.


TGA are still considering re-scheduling psilocybin from Schedule 9 to Schedule 8 with a decision due shortly.


Promethean BioPharma is supportive of these changes in the industry which it hopes will improve access to medications for more people.



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