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About this guideline
Overseas effective date: 1 July 2012
Categories: Biologicals | Finished product
TGA annotations:
This guidance states the warning to be included in the Product Information (PI) document of any plasma-derived medicinal product as follows:
The product-specific warning in Section 2 of this guidance is to be included in Section 'Precautions' of the Australian PI document (refer Form for providing Product Information).
A modification of the text in Section 3 of this guidance is to be included in Section 'Adverse Events' of the Australian PI document as follows: 'For safety information with respect to transmissible agents, see section Precautions'
- 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.