The Committee considers the following factors when reviewing a medicine for reclassification for OTC sale. The list is not ranked in any order of importance. The criteria may vary in importance according to the medicine being considered for reclassification. In some cases one factor alone may be sufficient to outweigh all others in determining whether or not a medicine should be reclassified. Consumer convenience Accessibility of the medicine and suitability for self-treatment .
Accessibility includes time and location factors.
The ability of a medicine to produce a wanted pharmacological effect. The availability of products with a similar therapeutic purpose. The margin between therapeutic and toxic effects. The potential of a substance to produce adverse preclinical and clinical effects. Adverse clinical effects will be assessed by frequency and severity.