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ARGOM Appendix 1: Guidelines on efficacy and safety aspects of OTC applications
5. Post-market experience
In some circumstances it may be appropriate to include details of adverse medicine reaction reports from Australia and/or from relevant authorities in countries with similar regulatory systems to Australia. Copies of 'Periodic safety update reports' (PSUR's) may also be relevant. Examples of circumstances where such information may be necessary include where active ingredients, fixed dose combinations, proposed indications or directions for use are new to the Australian market but have been marketed overseas.