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ARGOM Appendix 1: Guidelines on efficacy and safety aspects of OTC applications
1. Standard reference texts
For some OTC medicine applications, evidence to support safety and efficacy may be found in standard reference texts. Where this is the case, further information on the safety and efficacy of the product may not be required.
Applications based on standard reference texts should include an overview or covering letter referring to the texts and detailing their relevance (copies of the relevant pages should be provided).
The following are examples of reference texts which are usually acceptable as sources of information on the safety, efficacy and dosage regimen of ingredients in an OTC medicine:
- Handbook of Non-prescription Drugs, American Pharmacists Association, USA
- Martindale: The Complete Drug Reference, Sweetman SC (Ed.), Pharmaceutical Press, UK
- Remington: The Science and Practice of Pharmacy, Gennaro AR (Ed.), Lippincott Williams & Wilkins, USA
- Handbook of Pharmaceutical Excipients, Kibbe AH (Ed.), American Pharmacists Association, USA and Pharmaceutical Press, UK
- AHFS Drug Information, McEvoy GK (Ed.), American Society of Health System Pharmacists, USA
- Meyler’s side effects of drugs; Dukes MNG et al. (Eds), Elsevier
Current editions should be referenced unless otherwise justified. Note that limited clinical reports of efficacy alone or anecdotal reports (e.g. in Martindale "xxxx has also been used in ...") are not regarded as adequate evidence of safety and efficacy.
Reference texts alone will not usually be sufficient to establish safety and efficacy in the following circumstances:
- for ‘new’ active ingredients (i.e. not currently an active ingredient in any medicine on the Australian Register of Therapeutic Goods (ARTG));
- where bioequivalence data are required (see 'Section 6.1 Bioequivalence data')
- where therapeutic equivalence data are required for topical medicines (see 'Section 6.2 Therapeutic equivalence data - topical products');
- where the medicine is a nasal spray/aerosol containing a corticosteroid (see 'Section 7.1 Nasal corticosteroid sprays/aerosols');
- where the medicine is in a metered dose inhaler form (see 'Section 7.4 Metered dose inhalers');
- where the medicine is in a new dosage form compared to other medicines on the ARTG with the same active ingredient (see 'Section 8 Products with a 'new' dosage form');
- where the medicine contains a ‘new’ fixed dose combination of active ingredients (see 'Section 9 Fixed combination products')
- where the medicine is in a modified release dosage form (see 'Section 10 Modified release products'); and
- where the medicine has a route of administration that has not been used before for medicines on the ARTG with the same active ingredient