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Guideline on good pharmacovigilance practices (GVP): module vii - periodic safety update report (rev 1)

We have adopted this International Scientific Guideline - EMA/816292/2011 Rev 1.

Last updated

About this guideline

Overseas effective date:  13 December 2013

Replaces: pp. 21-32 and 139-145 of Rules 2001 (Vol. 9). Periodic Safety Update Reports (PSURs) Sections 1.4 and 3 of Part 1 (adopted by TGA 2 October 2002)

Categories: Pharmacovigilance

TGA annotations:

The TGA is adopting the Guideline on good pharmacovigilance practices (GVP) module VII Periodic Safety Update Reports (Rev 1) Sections VII. A, VII. B and VII.C. 4.3. - 6.1., including the EU-specific requirements and all appendices including those in VII.C.5. and after VII.C.9.3. Reference to specific European legislation, regulatory bodies and processes do not apply in Australia. The frequency of PSUR submission may not align with that in the EU and the usual requirement in Australia is that PSURs are to be submitted annually for 3 years post registration or after changes to registration, as specified in the approval letter. Section VII.C.7 does not, at this time, apply as the TGA is not proposing to publish PSUR reports or to routinely provide these to sponsors.

  • 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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