For indication extensions, a 3-year document protection period is generally granted. An extension to a total of 10 years is possible only upon request if the requirements for significant clinical benefit are met. Swissmedic explicitly describes this as an “extension of the document protection period from 3 to 10 years.”

The 10-year document protection period for “purely pediatric use” is a separate provision and requires that the medicinal product be intended “specifically and exclusively” for pediatric use; in the case of a purely pediatric indication for an existing medicinal product, this must be applied for in the form of a standalone product. A prerequisite for this and for obtaining 10 years of document protection is the submission of a PIP (Pediatric Investigation Plan).

Against this background, a cumulative selection (10 years of “significant clinical benefit” plus 10 years of “purely pediatric”) is not provided for in the case of a standard pediatric indication extension. The decisive factor is which condition is met in the specific case.

Document Protection and Pediatric Use