UK processing of PSURs/ PBRERs
Today we are concluding our foray into the topic of Periodic Safety Update Reports (PSURs) and Periodic Benefit Risk Evaluation Reports (PBRERs) by focusing on how these are processed for medicinal products in the UK.
Don’t forget to check out Today’s Top Tip below!
How should I submit my PSUR in the UK?
PSURs should be submitted through the PSUR portal using MHRA Submissions. You can be given access to MHRA Submissions by a company administrator in your organisation.
When should I submit my PSUR?
If you have just been granted a UK Marketing Authorisation (MA) you usually need to submit your PSUR:
every 6 months until the product is placed on the market
every 6 months for the first 2 years after the product is placed on the market
once a year for the following 2 years
At least initially the UK will continue to follow the European reference date (EURD) list so check this for the exact submission date relating to the active substance in your product, which overrides the general cycle* above.
*The cycle may also be different if you were given specific conditions when you applied for your MA.
What else do I need to know about these deadlines?
Although these deadlines have been set, the MHRA may request a PSUR at any time where appropriate.
Any PSUR, for a UK MA, with a submission deadline after 1 January 2021 will require a separate submission to the UK.
If you cannot find the submission date for your active substance on the EURD list the standard PSUR cycle should be followed.
Can I use my EU PSURs for the UK?
The EU versions of the PSUR can be submitted, but where the UK has made a specific request for information or where there is UK-specific information relevant to the benefit/ risk assessment this should be included in a specific annex.
Is there a template I can use?
A specific template is not available at this time.
What fees are involved?
£890 fee payable for assessment of PSURs for actives/ combinations currently listed on the EURD or future UK reference date (UKRD).
£445 (reduced fee) for each PSUR where more than one Marketing Authorisation Holder (MAH) is involved in the procedure.
What happens after my PSUR has been assessed?
Following assessment, the MHRA will publish the outcome of PSUR assessment procedures. No further fee will be payable for the amendment of the product information as a result of the assessment and updates will be made by a Type IA variation.
For information on when and how to submit your PSUR/ PBRER in the EU please see my previous blog in this series.
Today’s Top Tip
When the Marketing Authorisation Holder becomes aware of an emerging safety issue, they should notify the MHRA (email@example.com).
Do you have any questions, comments or need support in this area? If so then please get in touch with us here at Fusion Pharma – we love hearing from you:
firstname.lastname@example.org or Tel: +44 (0) 203 1379 799