Paediatric investigation plans: questions and answers
Table of contents
- Submitting documents
- Providing a research product identifier
- 1. Applying for a PIP, waiver or deferral
- 2. Articles 7 and 8: Definitions
- 3. Articles 33 and 35: Marketing a medicine authorised for a paediatric indication
- 4. Re-examination
- 5. Compliance statement
- 6. Modifying an agreed PIP
- 7. Request for confirmation of the applicability of the Agency decision on class waivers
- 8. EMA decisions on PDCO opinions
- 9. Transfers and changes in contact details
- 10. European Network for Paediatric Research at the European Medicines Agency (Enpr-EMA)
This page provides detailed guidance for companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver, as well as for companies that already have an agreed PIP. The information is available as questions and answers, which the European Medicines Agency (EMA) revises as necessary.
Applicants should consult this procedural advice in conjunction with the following key document:
- Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies
For general enquiries, including general information on PIP and waiver applications, modification procedures and compliance checks, please use AskEMA. The paediatrics (@ema.europa.eu) inbox is no longer in use (as of 31 May 2020).
It is mandatory for applicants to use the eSubmission Gateway / Web Client for all paediatric submissions to the Agency. Applicants should follow the guidance on paediatric submissions published on the eSubmission\paediatric submissions page.
EMA does not accept submissions that do not follow the published guidance on paediatric submissions, including using the correct submission channel.
Applicants should note that the xml delivery files for paediatric submissions changed in November 2020. An overview of changes is provided in the following presentation, with further information in an updated guidance on paediatric submissions below.
EMA advises applicants new to the eSubmission Gateway to submit their application well in advance of the targeted deadline.
Applicants need to provide their product's research product identifier (RPI) to carry out new paediatric procedures.
Applicants can request an RPI for their product via EMA's IRIS system, following the 'IRIS guide to registration' below.
EMA uses RPIs to improve the efficiency of its processes and create a single identifier for all pre-authorisation activities. The RPI replaces the previously-used unique product identifiers (UPIs).
The assignment of an RPI has no regulatory consequences on the status or classification of the product
Further guidance on paediatric submissions is available in the guidance document and Q&As below.
Forms and templates need to be opened with a PDF reader. EMA advises to save the document first, then use a PDF reader, such as Acrobat Reader, to open the form or template. To report any technical issues with the form, please use the EMA Service Desk portal.