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NIMAR vs Specials

NIMAR vs Specials

by Dr Lorraine Marsh | Dec 12, 2022 | Brexit, News, Regulatory Affairs, Regulatory Intelligence

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...
NIMAR vs Specials

NIMAR – A Closer Look

by Dr Lorraine Marsh | Dec 12, 2022 | Brexit, News, Regulatory Affairs, Regulatory Intelligence

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...
NIMAR vs Specials

An Introduction to the Northern Ireland MHRA Authorised Route (NIMAR)

by Dr Lorraine Marsh | Dec 12, 2022 | Brexit, News, Regulatory Affairs, Regulatory Intelligence

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...
Paediatric Investigation Plans (PIPs) in the UK

Paediatric Investigation Plans (PIPs) in the UK

by Leah Heathman | Jun 21, 2022 | Brexit, Regulatory Affairs, Regulatory Intelligence

Today we visit the topic of Paediatric Investigation Plans (PIPs) and all related submissions to the Medicines and Healthcare products Regulatory Agency (MHRA) – the UK Health Authority. The background to Paediatric Investigation Plans has been covered in our...
Brexit – CAP Renewals

Brexit – CAP Renewals

by Dr Lorraine Marsh | Sep 27, 2021 | Brexit, Regulatory Affairs, Regulatory Intelligence

Today we’re looking at renewals submitted for Marketing Authorisations (MAs) granted through the Centrally Authorised Procedure (CAP). For the basics on renewals please see my previous blog. A quick recap on how CAP licences will be handled – also see my...
ILAP – Innovative Licensing and Access Pathway

ILAP – Innovative Licensing and Access Pathway

by Dr Lorraine Marsh | Aug 4, 2021 | Brexit, Regulatory Affairs

Today we are focusing on the Innovative Licensing and Access Pathway (ILAP). What is the ILAP? The ILAP is a new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access. It aims to accelerate the...
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