GCP Inspections: Expectations and the dos and don’ts for hosting
19th March 2020
MHRA and EMA latest guidance on Brexit
23rd October 2020
On Monday 1 September 2020, the MHRA released an update to the guidance on pharmacovigilance post-transitional period and I am sure we all heard the emails pinging into our inboxes all afternoon.
The document clearly outlines the submission requirements for pharmacovigilance data as from the 1 January 2021.
As from the 1 January 2021, medicines authorised in Great Britain, all Marketing Authorisation Holders (MAH), will be required to submit pharmacovigilance data to the MHRA, in line with the GB requirements, these include the following:
- (ICSRs) – UK and non-UK Individual Case Safety Reports
- (PSURs) – Periodic Safety Update Reports
- (RMPs) – Risk Management Plans
- (PASS) Post-Authorisation Safety Studies-protocols and final study reports
We have all been bombarded with a huge amount of information, so to make things easier for you all our experienced PV Team here at PDS are working through all the updated guidance and breaking it down into bite size pieces.
Over the coming weeks, we will be adding this information to our website and we will also be updating the key areas that we work within with the new guidance, so please keep an eye on our website for clear and concise updates.
