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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...
SME status in the UK

SME status in the UK

by Nosheen Majid | Mar 9, 2022 | Medical, Pharmacovigilance, Quality, Regulatory Affairs, Regulatory Intelligence

Are you a small or medium-sized enterprise (SME)? If so the Medicines and Healthcare Products Regulatory Agency (MHRA) fees legislation currently has provision for some payment waivers for SMEs. What is the criteria for a small or medium company? The criteria that...
SME status in the EU

SME status in the EU

by Nosheen Majid | Mar 4, 2022 | Pharmacovigilance, Quality, Regulatory Affairs, Regulatory Intelligence

Are you a small or medium-sized enterprise (SME) established in the European Union (EU)/ European Economic Area (EEA)? If so the European Medicines Agency (EMA) provides incentives and support for SMEs developing medicines for humans. Criteria The main criteria are:...
International Expansion

International Expansion

by Guest Blogger | Nov 12, 2021 | Guest Blog, Medical, Quality, Regulatory Affairs, Regulatory Intelligence

We welcome Sue Allen, Senior Regulatory Affairs Consultant, to discuss the practical considerations of international expansion and the questions that should be asked during the planning and execution stages of licencing your pharmaceutical products globally. As...
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