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Special Access Scheme: Guidance for health practitioners and sponsors

Version 1.1, September 2017

6 January 2018

Book pagination

Version history

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

Book pagination