The current procedure for the Marketing Authorization of a novel Medicinal product requires agreement on a PIP with the submission of a full development plan at a very early stage of the product development. The PIP authorization is requested from the European Medicines Agency (EMA) and the relevant procedure is managed by the Paediatric Committee (PDCO). Currently, PIP applications are based on a fixed model. Applicants are allowed to come back to the PDCO each time a modification of a measure in the PIP is necessary.