Windsor Framework Webinar – The impact to pharmacovigilance activities for – PV and Regulatory
In this joint webinar hosted by Fusion Pharma and ADAMAS Consulting, Leah Heathman and Sarina Norris explore The Windsor Framework and the impact to pharmacovigilance activities in the UK. Covered in this webinar: A recap on the background of the Windsor Framework Windsor Framework measures and impact to Regulatory Overview of impact to artwork and […]
Windsor Framework Webinar with Leah Heathman
To prepare for the changes coming on 1st Jan 2025, Leah Heathman revisited the Windsor Framework, assessing its regulatory impact on your Marketing Authorisations and product packaging. In this informative webinar, Leah addressed: A brief overview of the Windsor Framework’s background Impacts on Marketing Authorizations for medicines sold in the UK (Great Britain and Northern […]
Windsor Framework Webinar for QPs / QA with Leah Heathman
A Windsor Framework for QPs / QA. In this webinar, Leah addressed: QP release of non-‘UK Only’ stock / supply of existing stock QP release of updated packs QP release of IE / EU packs still joint with UK / NI Artwork implementation timelines Use of ‘stickering’ FMD disapplication Key guidance and resources Access the […]
International Recognition Procedure Webinar with Leah Heathman
A webinar with Leah Heathman summarising the IRP and our experience so far. In this informative webinar, Leah addressed: What is the International Recognition Procedure (IRP) Where does IRP fit into the wider ‘post-Brexit’ MAA submission routes How to choose your Reference Regulator Using IRP for variations / life cycle management Is your company ready […]
NIMAR vs Specials
NIMAR vs Specials Following on from my other blogs on NIMAR (Northern Ireland MHRA Authorised Route) I have been asked about Specials. What is the difference between NIMAR medicines and Specials? We need to be careful to distinguish between supply under the NIMAR route and Regulation 167, which is the Specials Route: Specials are unlicenced […]
NIMAR – A Closer Look
NIMAR – A Closer Look Following on from my original blog titled ‘An Introduction to NIMAR‘, today we shall have a look in more detail, particularly focussing on Distribution of NIMAR medicines to Northern Ireland Advertising and promotion of medicines on the NIMAR list How are these products supplied to Northern Ireland via NIMAR? GB-based […]
An Introduction to the Northern Ireland MHRA Authorised Route (NIMAR)
An introduction to the Northern Ireland MHRA Authorised Route (NIMAR) What is the background to NIMAR? Following Brexit the UK Government brought in a new supply route, NIMAR, to ensure that prescription only medicines (POMs) are available to Northern Ireland (NI). What are the criteria for going down the NIMAR route? There must be […]