When it proves necessary to reassess the status of an existing self-medication product, the following steps are recommended:

(1) Review of the rationality of the product (single active ingredient or combination) its efficacy, adverse effects, patterns of use, and labelling, particularly in the hands of lay consumers.

(2) Assessment of the benefit/risk ratio of the product.

(3) Consideration of steps to be taken to deal with emerging problems. When steps have been taken already, e.g. the publication of warnings or imposition of limitations on package size or distribution, the effect of such measures should be assessed.