What is the timeline for submission of PSUR? PSUR Submission Cycle For most newly authorised products, PSURs should be submitted every 6 months until initial placing on the market. Following placing on the market they
What is the timeline for submission of PSUR?
PSUR Submission Cycle For most newly authorised products, PSURs should be submitted every 6 months until initial placing on the market. Following placing on the market they are submitted: every 6 months for the first 2 years; annually for the subsequent 2 years; and.
What is PSUR clinical trial?
A Periodic Safety Update Report (PSUR) is a pharmacovigilance document intended to provide an update of the worldwide safety experience of a medicinal product to regulatory authorities at defined time points post-authorisation.
What is included in Pader?
A PADER includes introductory paragraph, which is followed by summary of tabulation (providing bifurcation on number of serious/nonserious and domestic/foreign cases), description of 15-day alert cases, regulatory section, conclusion, and lastly appendices (package insert and line listings).
When do you need to submit a PSUR in the UK?
You must submit a periodic safety update report (PSUR) for all approved medicinal products in the UK (unless they are covered by the derogation given in the Human Medicines Regulations 2012, as amended). The PSUR is a periodic assessment of the risk-benefit balance of the product.
How to submit your periodic safety update report ( PSUR )?
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER) You must submit a periodic safety update report (PSUR) for all approved medicinal products in the UK (unless they are covered by the derogation given in the Human Medicines Regulations 2012, as amended).
When do psurs no longer need to be submitted to MHRA?
From 13 June 2016 it will be compulsory for all PSURs to be submitted to the repository. This will apply for all products including those only approved in the UK. From 13 June 2016 there will no longer be submission of PSURs to the MHRA or any other national competent authority.
Is the use of the PSUR repository mandatory?
Use of the PSUR repository is mandatory for both centrally and nationally authorised medicines, whether they follow the EU single assessment or a purely national assessment procedure.