Spe­cial Ac­cess Scheme on­line sys­tem

Pharmacy Daily - - Front Page -

THE Ther­a­peu­tic Goods Ad­min­is­tra­tion has re­leased de­tails of its new on­line sys­tem to en­able the elec­tronic sub­mis­sion of Spe­cial Ac­cess Scheme (SAS) ap­pli­ca­tions and no­ti­fi­ca­tions to the TGA.

This month the sys­tem was up­dated to al­low the sub­mis­sion of Au­tho­rised Pre­scriber ap­pli­ca­tions, with the sys­tem aim­ing to re­duce the ad­min­stra­tive bur­den on health prac­ti­tion­ers.

While lodge­ment of SAS and AP ap­pli­ca­tions and no­ti­fi­ca­tions via the on­line sys­tem is not manda­tory, it is the pre­ferred method of sub­mis­sion, with the TGA aim­ing to move the sub­mis­sion of all SAS and AP re­quests on­line by 01 Jul 2019.

The TGA noted that in cer­tain cir­cum­stances the SAS on­line sys­tem should not be used for medic­i­nal cannabis sub­mis­sions.

Such sit­u­a­tions in­clude where the pre­scriber of the un­ap­proved ther­a­peu­tic good is not a med­i­cal prac­ti­tioner, or where the pre­scriber is in pos­ses­sion of a cur­rent TGA ap­proval and the no­ti­fi­ca­tion/ap­pli­ca­tion only re­lates to a par­tic­u­lar state or ter­ri­tory.

Med­i­cal prac­ti­tion­ers ac­tu­ally pre­scrib­ing the medic­i­nal cannabis prod­uct must make the sub­mis­sion via the sys­tem - tga.gov.au.

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