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

4.4 Assessment of new strengths, formulations, doses, indications or combinations

Careful assessment is also necessary when it is proposed to make the medicinal product available without prescription in a new strength, in a new formulation, at a new dose, using a new route of administration, for a new age group or for a new indication, particularly if the indication has not previously been approved without a medical prescription. In addition to an assessment of the rationality of such a proposal, the safety and benefit/risk of a medicinal product in the new circumstances should be evaluated.

A medicinal product containing a new combination of two or more active substances, which are available in two separate products, neither of which is subject to a medical prescription, will not automatically be classified as a non-prescription product. The applicant needs to demonstrate that the combination offers an advantage over the separate active substances, and that the risk is acceptable.

to previous section
to next section
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 6, 2017