The 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, from the European Commission, specifies the information to be included in the application.

For products that are already authorised, the PIP application should cover all the existing and the new indications, pharmaceutical forms and routes of administrations (where relevant), in keeping with the Global Marketing Authorisation concept (see question 2.1. 'When is my product considered 'not authorised in the Community' below).

Proposed pharmaceutical form(s)
(in relation to the proposed paediatric development, page 1)

In this section, for authorised products, all existing pharmaceutical forms and new pharmaceutical forms under development for the proposed PIP should be listed, irrespective of whether you request a waiver, or a PIP with or without deferral. You should specify whether the pharmaceutical form is under development or is already authorised.

For authorised, off-patent products intended for a future PUMA application, only the pharmaceutical forms discussed in the PIP should be mentioned. You should also specify whether each of the pharmaceutical form is under development or is authorised.

Here, 'authorised' means authorised in at least one Member State of the European Union.

Request for a waiver

In this section, if there is more than one condition in your application, you should repeat the information for each condition, by clicking on the 'add' button. To delete a condition, click 'delete'.

You should select the appropriate age group or other paediatric subset where the waiver applies. You have the ability to select specific groups that differ from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) classification, if this is more appropriate.

Please tick the grounds for the waiver for each age group/subset mentioned in this section.

For products belonging to a class of medicinal products included in the Agency's list of class waivers, see 'What shall I submit if my product belongs to a class listed in the Agency's decision on class waivers?'

Name of the active substance

You should select the appropriate nomenclature following the priority order. There is no need to select more than one nomenclature. If you use a chemical formula name, please add the company code.

Details of the medicinal product

The proposed pharmaceutical form mentioned on page 1 should be associated here with the corresponding route(s) of administration. If an additional formulation is under development (an adult formulation for example), it should be listed here. Please use the list of standard terms from the European Pharmacopoeia.

Date of completion of human pharmacokinetic studies in adults / planned submission of application

For technical reasons, these dates must be input in the format dd/mm/yyyy. If an exact date cannot be specified, you should select the last month of the proposed interval, and select the last day of that month by default (e.g. 31/07/2020 for July 2020, or for January-July 2020).

The same rules apply if you would like to select a trimester for example, please use the last month of the trimester. Please note that these dates are not binding, but are important for the discussion on deferrals.

Person authorised to communicate with the EMA during the procedure and after the decision

EMA communicates exclusively with the authorised contact person appointed by the applicant in 'part A' of the application. Applicants may prefer to use a generic professional email address for the authorised person, to ensure a smooth and timely communication flow.

EMA sends all of its communications, including the PDCO opinions and the EMA decisions, electronically only to the appointed contact person's email address, unless requested in writing otherwise.

Therefore, applicants should keep EMA informed of any change to the contact person or contact details. For more information, see question 9. 'Is there a procedure for changing the PIP applicant name or details?'

Contact point for the applicant for public enquiries from interested parties

At the time of publication of the EMA decision on the Agency's website, this contact will be made public. A generic e-mail address and telephone number (and fax if available) are therefore preferable. In case of changes, please refer to Q&A 9.1 (Changes of applicant/addressee and contact details: how to notify the Agency?).

RPI number 

The RPI number is mandatory. The assignment of an RPI has no regulatory consequences on the status or classification of the product.