Modification of various documents relating to authorisation

09.04.2019

Further details in chapters 5.4, 6.2.2 and 6.3

Part A of the form
Chapter 3.1: Further detail on the documentation to be supplied if EMA PIP or US PSP

Greater detail on the documentation to be supplied for a foreign Paediatric Investigation Plan (EU PIP or FDA PSP)
Addition to the documentation to be supplied for KAS without innovation as per Art. 14 para. 1 letter abis-quater TPA
More precise wording in the documentation to be supplied as per Art. 14 para. 1 letter ater -quater TPA

Chapter 7.2: Acceptance of “Documentation on therapeutic effect” (Art. 11 para. 2 letter a, sec. 3 TPA)
Chapter 8.2: Harmonisation of the wording in the documents to be supplied

The new versions of the affected documents enter into force as of 08.04.2019.