In the case of a new marketing authorisation, the applicant can submit a PIP (Paediatric Investigation Plan) already approved by a foreign medicines authority to Swissmedic which has comparable medicines control or a PIP newly prepared for the Swiss marketing authorisation (CH-PIP). A PIP already approved by a foreign medicines authority with comparable medicines control will be accepted by Swissmedic without carrying out its own assessment.
According to Chapter 5.3.2.2 of the Guidance document Paediatric Investigation Plan, subsequent amendments to PIPs approved by foreign authorities should not be submitted to Swissmedic. Such amendments subsequently approved by the foreign authority (including, for example, changes to the time limits for fulfilling individual PIP measures) are accepted by Swissmedic unseen, without the need for the applicant to keep Swissmedic updated.
An updated PIP can only be submitted to Swissmedic as part of an application, for example, when adapting the medicinal product information for Professionals, if changes to the medicinal product information for Professionals are required as a result of PIP study results.
If all the conditions specified in the PIP are fulfilled and the paediatric data are integrated in the summary of product characteristics in a suitable form and approved, a corresponding written confirmation can be requested from Swissmedic. This confirmation is issued as an official decision and can be used to apply to the Federal Institute of Intellectual Property for a 6-month extension of the supplementary protection certificate.
