UK – Completed Paediatric Studies – submission, processing and assessment in the event of a no deal scenario

This document provides guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs) in the event of a no deal scenario.

The UK is leaving the EU on 29 March 2019. Securing a deal remains the Government’s top priority. This has not changed. However, the government must prepare for every eventuality, including a no deal scenario.

This guidance follows on from the guidance published on 3 January 2019 and the letter communicated in November 2018 and January 2019.

Regulation 78A(13) and (14) of the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, requires that holders of a UK marketing authorisation who sponsor a study which involves use in the paediatric population in respect of the medicinal product to which that authorisation relates must submit to the Medicines and Healthcare products Regulatory Agency (MHRA) results of the study within the period of six months beginning with the day on which the trial ended.

This obligation applies irrespective of whether or not:

  • the studies are conducted in accordance with an agreed paediatric investigation plan (PIP); or
  • the MAH intends to apply for a marketing authorisation for a paediatric indication in relation to the product.

These provisions replace Article 46 of Regulation (EC) No 1901/2006 (the ‘Paediatric Regulation’).

MHRA will also consider the outcome of CMDh paediatric work-sharing procedures (PdWS) reviewed under Article 45 of Regulation (EC) No 1901/2006 (as amended). If required, MHRA will request updates to the product information (PI) for UK Marketing Authorisations…