Special Access Scheme: Guidance for health practitioners and sponsors

Print version

Version 1.1, September 2017

5 January 2018

Version	Description of change	Author	Effective date
V1.0	Original publication	Pharmacovigilance and Special Access Branch and Regulatory Guidance team	July 2017
V1.1	To clarify the requirements in relation to the types of adverse events and effects that should be reported and the time period within which this should be done.	Pharmacovigilance and Special Access Branch	September 2017