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. Collection and regulatory assessment of evidence for medicinal products intended for self-medication

When drug regulatory authorities assess applications for marketing authorization, three types of situation need to be distinguished:

(1) Assessment of new active substances, not marketed as prescription medicines and designed specifically for use in self-medication.

(2) Assessment for self-medication of medicinal products hitherto available only on prescription.

(3) Assessment of existing self-medication products that have not previously been evaluated.

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