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Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products

We have adopted this International Scientific Guideline - EMA/CHMP/BWP/360642/2010 rev. 1 

Last updated

 

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.

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