The use of the research product identifier (RPI) is used to make EMA processes more efficient by creating a single identifier for all pre-authorisation activities and it is already required for procedures such as the Scientific Advice request or the application of Orphan Drug Designation.
Starting from 10 October 2021, the RPI number is also necessary to carry out new Paediatric Procedures. In particular, the RPI number is a mandatory field in the updated electronic application form for paediatric investigation plans (PIPs), modifications of agreed PIPs, and requests for waivers, which is availableon the EMA website.
Applicants that approach EMA for the first time with a new medicinal product and do not have a previously assigned RPI, will need to request a new RPI via the IRIS platform after verifying that the Active Substance in the product is registered and appear as “authorised” on the official EMA list of all substances (SMS).
Regulatory Pharma Net (RPN) has successfully supported companies in the early dialogue procedures with EMA, including the Paediatric procedure (PIP).
RPN is already registered on IRIS and can offer support to companies that need to request the RPI to fulfill the EMA requirements.