Following its assessment of any application for a paediatric investigation plan, including deferral, waiver or modification of an agreed PIP, the Paediatric Committee formulates an 'opinion', which is delivered to the applicant. The applicant is then given an opportunity to request a re-examination of the opinion. In this case, the Paediatric Committee will consider the grounds for a re-examination of the opinion and will adopt a 'definitive opinion' on the application. The European Medicines Agency then adopts a 'decision', based on the definitive opinion of the Paediatric Committee, which the Agency communicates to the applicant.
According to the Paediatric Regulation, all decisions of the Agency on paediatric investigation plans, deferrals or waivers of the paediatric development have to be made public, after deletion of any information of a commercially confidential nature.
- For decisions on PIP applications, see: Product-specific decisions