Completed Paediatric Studies - Submission, Processing and Assessment from 1 January 2021

Holders of a UK marketing authorisation who sponsor a study that involves use in the paediatric population must submit to the Medicines and Healthcare products Regulatory Agency (MHRA). This applies irrespective of whether or not the study is conducted in accordance with an agreed paediatric investigation plan (PIP). The MAH should indicate in the cover letter whether the study(ies) 1.1 is/are linked to other paediatric studies which have been or will be the subject of other submissions under Regulation 78A of the Human Medicines Regulations 2012.

MHRA will carry out an initial appraisal of whether an assessment procedure is required at this stage. If the study(ies) relate to a UK PIP, the MAH should provide the PIP number. The MAH should provide relevant information about related Article 46 of Regulation (EC) No 1901/2006 procedure(s) or EU agreed PIP(s).

MHRA will notify the MAH to submit the paediatric data within 60 days as a type II variation application (change code C.I.13 - complex type II variations fees will be applicable).

If the results of a paediatric study have been submitted to the EMA or CMDh under Article 46 of Regulation (EC) 1901/2006 prior to 1 January 2021, the process will remain within the EU assessment framework. If there are proposed changes to the PI, which can be directly implemented to relevant UK products, the MHRA will request MAHs to submit a Type IB variation to update the PI within 60 days.

Source: MHRA guideline on Completed Paediatric Studies - submission, processing and assessment from 1 January 2021


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