MHRA has published
updated guidance on pharmacovigilance procedures on 01 September 2020 and new
rules will be effective from January 2021 (post-Brexit transition period comes
to an end this year).
1.
General Approach to the operation of pharmacovigilance
This document
outlines the submission...
Showing posts with label Brexit. Show all posts
Showing posts with label Brexit. Show all posts
Sep 2, 2020
Sep 30, 2019
PSUR submission summary in the United Kingdom (UK) about a possible no-deal Brexit
Drug Safety Guru
Brexit, PSUR, Submission
Periodic Safety Update Reports (PSURs):-A. PSURs submitted after exit daya. MHRA will continue to accept EU version of PSURsb. MHRA specific request for information needs to be included in specific annexurec. MHRA has developed its own submission requirements and develop a list of...