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Comments column for Boric acid (and borates) in the Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' (SANTE-2017-11668)

We have adopted this International Scientific Guideline - EMA/CHMP/302620/2017. 

Last updated

About this guideline

Overseas publication date:  9 October 2017

Categories: Clinical efficacy and safety | General 

TGA annotations:

The TGA is adopting guidance in the comments column of the Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' in relation to Boric acid (and borates) only. The comments column provides guidance on the amount of boron per age group which may impair fertility or cause harm to the unborn child if exceeded. This should be used by sponsors as guidance to inform dosage instructions for different age groups where a boron-containing ingredient is used as an excipient in medicines. The TGA is not adopting any other part of the Annex to the EC guideline, including the required warning statements for boric acid (and borates), as the need for warnings is negated if dosage guidance is adopted.

  • 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.
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For more information see International scientific guidelines adopted in Australia.

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