Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020. This webinar was part of a series of Brexit and post-transition guidance webinars:
Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020
Further information regarding the impact on Pharmacovigilance following the implementation of the Windsor Framework for UK authorised products can be found within our pharmacovigilance Windsor Framework guidance and Q&A document.
Added further information on EURD list under section 5.2 of guidance
Links added to guidance and webinar on Windsor Framework
The guidance on Pharmacovigilance Procedures has been updated to include further details on submission requirements for the MHRA, in particular relating to signals, Risk Management Plans (RMPs) and Post Authorisation Safety Studies (PASS). The section on Periodic Safety Update Reports (PSURs) has been updated with new requirements for submission of PSURs for products authorised in Northern Ireland. Additional sections have included on MHRA Safety Reviews and Safety Communications.
The guidance on pharmacovigilance procedures has been updated to provide clarity on submission and documentation requirements for various pharmacovigilance procedures including where the reliance procedure is used.
New video entry - Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020
Updated section 2 to include a list of reports received via the EMA from the 28 December to the 31 December
Excerpt from the official page. The original is authoritative.