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Special Access Scheme: Guidance for health practitioners and sponsors
Print version
Version 1.1, September 2017
6 January 2018
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 |