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Quality and Safety: Medicines
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self-medication
Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication
(2000; 31 pages)
Table of Contents
1. Introduction
2.4 Characteristics of self-medication
3. General basis for regulatory assessment
3.1 Established properties
3.2 Approaches to regulatory assessment and supervision
4. Collection and regulatory assessment of evidence for medicinal products intended for self-medication
4.1 Assessment of new active substances not marketed as prescription medicines and designed specifically for use in self-medication
4.2 Assessment for self-medication of medicinal products hitherto available only on prescription
4.3 Assessment of existing self-medication products that have not previously been evaluated
4.4 Assessment of new strengths, formulations, doses, indications or combinations
Annex
Acknowledgements
3. General basis for regulatory assessment
The basic criteria for a self-medication product are outlined in paragraphs 2.3 and 2.4 above.
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© WHO 2013
Last updated: May 3, 2013
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