Periodic Safety Update Reports (PSURs):-
A. PSURs submitted after exit day
a. MHRA will continue to accept EU version of PSURs
b. MHRA specific request for information needs to be included in specific annexure
c. MHRA has developed its own submission requirements and develop a list of UK reference dates, but until this happens the EU reference date (EURD) list should be followed and PSURs
d. PSUR submission dates after exit day should be submitted to the UK the same time as submission to the EU
e. The content and format of PSUR will be the same as the EU
f. It is expected the same PSUR will be submitted to the UK and EU
g. PSURs for actives/combinations not currently on the EURD list should be submitted to us according to the usual frequency
h. MHRA submission portal for PSUR will be ready for use before exit day
i. Submission to the portal via a delivery file with the PSUR as part of eCTD
j. A fee of £890 will be payable for the assessment of PSURs for actives/ combinations currently listed on the EURD (or future UK reference date list) but there will be a reduction to £445 for each PSUR where more than one PSUR is involved in the procedure
k. MHRA will publish the outcome of the PSUR assessment procedures
l. No further fees will be payable
B. PSURs submitted before exit day
a. Where a PSUR has been submitted before exit day but the EU single-assessment procedure has not been concluded, we will assess the PSUR considering any relevant information, including any EU decision and may request further information, where appropriate, in order to conclude the assessment
b. Where the assessment has been concluded but the outcome not implemented on exit day, the MHRA will take the necessary steps to implement the outcome
Source: https://www.gov.uk