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Scientific Advice Meetings with the MHRA

Scientific Advice Meetings with the MHRA

by Nosheen Majid | Jan 26, 2023 | News, Regulatory Affairs

Why might I need a Scientific Advice Meeting? Do you have a questions for the Medicines and Healthcare products Regulatory Agency (MHRA) about the development of your medicine, a Marketing Authorisation Application (MAA) or a variation?  Then you may benefit from a...
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...
Paediatric Investigation Plans (PIPs) in the EU

Paediatric Investigation Plans (PIPs) in the EU

by Nosheen Majid | Apr 29, 2022 | Regulatory Affairs, Regulatory Intelligence

Today I’m writing a short blog to introduce Paediatric Investigation Plan (PIP) submissions to the European Medicines Agency (EMA). What is a Paediatric Investigation Plan (PIP)? • A PIP is a development plan aimed at ensuring that the necessary data are...
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