Paediatric submissions in IRIS: one condition per submission

In IRIS each submission for a Paediatric Investigation Plan or a Product-specific Waiver must specify a single condition. For example, if a PIPs is required for two separate conditions (not indications in the same condition), then two separate submissions are required, one for each condition, and separate Regulatory Entitlements will be generated by IRIS after a positive decision.  

This is due to legal and technical reasons, among which the following are of particular relevance: 

1. Regulatory entitlements for development-related procedures in IRIS are linked to a single condition, as for Scientific Advice and Orphan Designations.

2. Art. 14 of the Paediatric Regulation requires EMA to publish a list of the waivers granted, which is not possible if a Regulatory entitlement contains several conditions, for some of which a PIP may be granted and for others a Product-specific waiver is granted. Regulatory entitlements for paediatric applications are thus of two categories, Paediatric Investigation Plan (with or without deferrals or partial waivers) and Product-specific waiver.  

3. Experience with the past system and database has shown that it is more convenient for applicants to have separate PIP decisions for different conditions, to prevent the "never-ending PIP" issue and to be able to claim the reward after completion of development in a single condition (i.e. after completing the "reward PIP"). For additional information on this, please see EMA policy on changes in scope of PIP decisions (europa.eu).

Each submission should contain all the relevant information and documents. It is of course possible to re-upload the same document(s) several times, and copy paste the same data sections for more than one application, whenever the applicant believes this to be appropriate. In IRIS, it is possible to open multiple instances of the IRIS portal in different browser tabs, at the same time, and create separate submissions in parallel. 

Based on this recommended practice of 'one condition per PIP submission', what will it's impact be in the circumstances where a PIP modification is required to an existing PIP which had been submitted with more than one condition already noted in the PIP? 

Current legislation does not explicitly prevent a single EMA decision from covering multiple conditions with a paediatric investigation plan and/or product-specific waiver(s), even if this may not be in the applicant's best interest. As such, if an applicant desires to modify an existing PIP regulatory entitlement covering multiple conditions, this is still possible; it is sufficient to submit the application on the basis of the existing Regulatory Entitlement. Alternatively, the applicant may decide to "split" the PIP decision beforehand. For further information on the likely consequences of each course of actions, please see the following documents available on the EMA website:

• EMA policy on changes in scope of PIP decisions
• Presentation - One PIP or multiple PIPs?