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ARGOM Appendix 1: Guidelines on efficacy and safety aspects of OTC applications

Version 1.0

29 November 2015

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4. Preclinical studies

In most cases, OTC medicines have a substantial history of use in humans, reports of trials in animals are usually not required. However, for products with ‘new’ ingredients, new fixed dose combinations, new routes of administration, higher than normally accepted dosages or for use over a longer period of time, animal trial data will be required unless otherwise justified (see also ARGOM - Appendix 4 Guideline on OTC applications for new substances). Where there is a substantial history of use in comparable regulatory jurisdictions (e.g. UK, Canada, US) it may be acceptable to provide a safety in use substantiation from post market surveillance data as an alternative to preclinical studies (see 'Section 5 Post-market experience').

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