Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication
(2000; 31 pages) View the PDF document
Table of Contents
Open this folder and view contents1. Introduction
Open this folder and view contents3. General basis for regulatory assessment
Close this folder4. Collection and regulatory assessment of evidence for medicinal products intended for self-medication
View the document4.1 Assessment of new active substances not marketed as prescription medicines and designed specifically for use in self-medication
View the document4.2 Assessment for self-medication of medicinal products hitherto available only on prescription
View the document4.3 Assessment of existing self-medication products that have not previously been evaluated
View the document4.4 Assessment of new strengths, formulations, doses, indications or combinations
View the documentAnnex
View the documentAcknowledgements
 

4.3 Assessment of existing self-medication products that have not previously been evaluated

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.

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