MHRA Active Substance Registrations
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 Medicines and Healthcare Products Regulatory Agency (MHRA). A flow chart is available to help you decide which […]
MHRA Wholesaler Dealer’s Licence (WDA(H))
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 require a Wholesale Dealer’s Licence (WDA(H)) if, in the course […]
MHRA Manufacturer’s Licence (MIA)
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 are manufacturing licensed, unlicensed or investigational medicinal products: Manufacturer/importer licence (MIA): Manufacture and/or assemble licensed medicinal products Import […]
SME status in the UK
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 needs to be met in the UK in order to be defined as […]
SME status in the EU
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 criteria are: Category Head count Annual turnover Or balance-sheet total Medium-sized < 250 ≤ € 50 m […]
International Expansion
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 developed markets continue to stagnate, emerging markets are becoming even more important as a source of revenue growth for […]
Compliance Culture
It is our pleasure to introduce Julie Yeoman as one of our guest bloggers, who writes so passionately about compliance and visits the core of company culture, an interesting angle in such a process driven industry. Working in the field of healthcare compliance for over 20 years, Julie starting her career with AstraZeneca where she […]
The Importance of Cross-functional Working – a Marketing Perspective
We are delighted to introduce Michelle Bridgman who brings along with her 10 years of experience working as a Pharmaceutical Brand Marketer with Prescription Medicines, OTCs and Medical Devices. Michelle understands well the benefits and importance of cross-functional working and discusses this here in more detail and from a Marketing perspective. We are all […]
Quality and manufacturing strategy during product development planning
During 30 years’ experience in medicines and device development it has been my observation that insufficient attention is paid to the importance of quality and manufacturing strategy during product development planning. In particular, the need to generate the required information for submission in regulatory applications. The focus early on is placed firmly on clinical development. […]