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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...
MHRA Active Substance Registrations

MHRA Active Substance Registrations

by Nosheen Majid | Sep 7, 2022 | Quality, Regulatory Affairs, Regulatory Intelligence

Today’s blog will help you navigate registrations for Active Pharmaceutical Ingredients (API), sometimes referred to as the ‘Drug Substance’. If you manufacture, import or distribute API(s) and you are based in the UK you must register with the...
MHRA Active Substance Registrations

MHRA Wholesaler Dealer’s Licence (WDA(H))

by Nosheen Majid | Sep 6, 2022 | Quality, Regulatory Affairs, Regulatory Intelligence

Do you need a Wholesale Dealer’s Licence (WDA(H)) to conduct your business in the UK?  If so, our blog below provides an outline of where to start and how to apply to the Medicines and Healthcare Products Regulatory Agency (MHRA). Persons operating from the UK...
MHRA Active Substance Registrations

MHRA Manufacturer’s Licence (MIA)

by Nosheen Majid | Sep 5, 2022 | Quality, Regulatory Affairs, Regulatory Intelligence

To manufacture, assemble or import medicinal products for human use, you need a Manufacturer’s Licence (MIA) issued by the Medicines and Healthcare Products Regulatory Agency (MHRA).  There are different manufacturer licences available depending on whether you...
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