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Guidance on Licensing Biosimilars, ATMPs and PMFs from 1 January 2021

The way you apply to licence biological products will change from 1 January 2021.
From 1 January 2021, the MHRA will regulate products according to the same principles that are applicable now. Northern Ireland will follow the EU acquis and MHRA will regulate applications for biosimilars accordingly. New applications to Great Britain will be assessed at national level and should be submitted using existing procedures for national applications.

ATMPs will be regulated nationally in relation to Great Britain by the MHRA. In Northern Ireland ATMPs will continue to be regulated according to the EMA's Centrally Authorised Procedure.

The MHRA will continue to recognise the existing PMF and associated inspections. In the interim, we require the PMF holder to notify the MHRA of the outcome of the annual updates. MHRA reserve the right for further review where an EU assessment report is deemed to indicate significant public health issues.

For variation applications submitted to the EMA, the PMF holder must notify the MHRA of the submission and determination outcome of such an application within four (4) weeks of the submission and determination dates, respectively.

MHRA will issue guidance on the transfer of PMFs to the MHRA database when this becomes relevant, but the data requirements will be in accordance with those currently in place in the EU.

This guidance will apply from 1 January 2021 in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.

Source: MHRA guideline on Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021

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