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About this guideline
Adopted by the TGA: 1 August 2025
Overseas effective date: 02 July 2012
Categories: Pharmacovigilance | Regulatory and procedural guidance
TGA annotations:
Where the EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not legally applicable to medicines sponsors in Australia. The sponsor should consider the EU guideline as recommendations for establishment and maintenance of their pharmacovigilance system. Sponsor should refer to the current version of Pharmacovigilance responsibilities of medicines sponsors - Australian recommendations and requirements for the legal Australian requirements.
For Section I.B.10 Record Management - Further information about the obligations in relation to the collection, use and disclosure of personal information can be found in the Australian Privacy Principles, the Privacy Act 1988 and Pharmacovigilance responsibilities of medicines sponsors - Australian recommendations and requirements for the Australian requirements.
For Section I.C.2, this section is not applicable in Australia.
For section I.C.3, Please refer to the Australian Privacy Principles, the Privacy Act 1988 and Pharmacovigilance responsibilities of medicines sponsors - Australian recommendations and requirements for the Australian requirements for more information about Australian requirement regarding data security.
- Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
- All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.
For more information see International scientific guidelines adopted in Australia