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Guideline on the exposure to medicinal products during pregnancy: need for post-authorisation data

We have adopted this International Scientific Guideline - EMEA/CHMP/313666/2005

Last updated

About this guideline

Overseas effective date:  May 2006

Categories: Pharmacovigilance | Regulatory and procedural guidance

TGA annotations: Nil
  • 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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