This guidance addresses the common scenarios that may occur when a UK paediatric procedure is submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) after 1 January 2021. The guidance also covers information for applicants or companies with an agreed EU-PIP opinion conferred prior to 1 January 2021.
A case by case discussion should always be considered for any UK paediatric submissions that do not fall into any of the prespecified criteria. Further step by step information on the process of submitting PIPs via the new MHRA submissions portal will be available in a user reference guide which will be published separately.
UK-PIPs submitted after 1 January 2021 will be referred to as agreed UK-PIPs. If a UK-PIP is submitted, information should be provided on whether there is an agreed EU-PIP. If the PDCO opinion is negative, the applicant has the option to withdraw the UK PIP or continue with the MHRA assessment.
If a UK-PIP has been withdrawn and a new UK-PIP submitted, the new PIP will undergo review using the same assessment criteria as noted in Section 1 of this guidance.
The current EMA class waivers list will be adopted by the UK from 1 January 2021. In principle, the MHRA will aim to accept a positive EMA opinion on a class waiver request. For a negative EMA opinion on whether a Class Waiver applies: the applicant should submit a full product specific waiver request for MHRA assessment.
A PDCO CC will be adopted as the UK CC outcome unless subsequent modifications have led to divergence between the UK- and EU-PIPs. The format and submission procedure for UK-PIP applications will be published separately.
Legal requirements for UK-PIPs are set out in the Human Medicines Regulations 2012. This guidance will apply from 1 January 2021 in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.