MHRA Applications – One strike and it’s out
Earlier this year the MHRA published new guidance on established medicines, the guidance came into force on 1st March 2024. The aim of the guidance is to ensure that applications are right first time, which allows for timely processing of marketing authorisation applications for establishes medicines and applies specifically to chemical products. The main changes […]
InFusion: Membership update
In our last newsletter we introduced you to InFusion, our new membership designed to support Regulatory Affairs Departments and professionals within the UK. Over the past couple of months we have been working hard to develop high quality content for ‘InFusion Graduate‘. I am personally excited about this new offering as I see a real […]
The Innovative Devices Access Pathway (IDAP)
The Innovative Devices Access Pathway (IDAP) is currently in its pilot phase. IDAP has been designed to accelerate the development of innovative medical devices where there is currently an unmet need in the NHS. Specific eligibility and innovation criteria needed to be met for successful entry to the IDAP pilot. There is a list for the eligibility […]
MHRA RegulatoryConnect Portal
Last week the Medicines and Healthcare products Regulatory Agency (MHRA) held a webinar for the launch of the new MHRA RegulatoryConnect Portal that is due to be released at the end of March. So what is the aim of the new MHRA RegulatoryConnect Portal? The aim of the RegulatoryConnect Portal is to allow for greater […]
PRIME: PRIority MEdicines – An Update
What is PRIME (priority medicines)? PRIME (priority medicines) is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. My previous blog introducing PRIME can be found here. What is the update regarding PRIME? The EMA published a report presenting results from the first five years of […]
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 […]
Paediatric Investigation Plans (PIPs) in the EU
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 obtained through studies in children, to support the authorisation of a medicine for children. […]
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 […]