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 […]
Paediatric Investigation Plans (PIPs) in the UK
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 blog on PIPs in the EU and is also applicable to the UK. Similarly to the […]
Brexit – CAP Renewals
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 previous blog on this subject: All existing MAs authorised through the CAP will automatically be […]
ILAP – Innovative Licensing and Access Pathway
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 time to market, facilitating patient access to medicines. Horizon scanning and regulatory […]
Project Orbis
Today we are focusing on the Project Orbis initiative, with a UK slant. What is Project Orbis? Project Orbis is an innovative programme coordinated by the US Food and Drug Administration (FDA) involving several other participants. The programme has been set up to allow participating partners to review and approve applications for promising cancer […]
Access Consortium
Today we’re focusing on the Access Consortium. The trend towards globalisation of therapeutic products industries and the rapid emergence of new technologies in the last decade accompanied with shared global challenges have created an increased need for regulatory bodies to co-operate and communicate with each other routinely. This maximises the use of up-to-date technical expertise, […]
Brexit – Impact of COVID-19
On 23 June 2016, the United Kingdom narrowly voted to leave the European Union, a decision which has impacted the lives of millions of people. Once the results of the historic vote were revealed, who would have predicted that the process to leave the European Union would take four and a half years. While […]
COVID-19 – Impact on Hospital Patients
In response to the COVID-19 pandemic, and to prevent the NHS being overwhelmed due to a rapid increase of COVID-19 cases, the UK Government made a decision on 16th March 2020 to put the population of the UK into lockdown. Before the pandemic began, the BBC reported that 1,600 patients were waiting for non-urgent […]