(2000; 31 pages)
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.