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 UK
Today we visit the topic of Paediatric Investigation Plans (PIPs) and all related submissions to the Medicines and Healthcare products Regulatory Agency (MHRA) – the UK Health Authority. The background to Paediatric Investigation Plans has been covered in our blog on PIPs in the EU and is also applicable to the UK. Similarly to the […]
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. […]
PRIME: PRIority MEdicines
In today’s blog I will be taking a look at PRIME (priority medicines), a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. PRIME in a snapshot 1) PRIME focuses on medicines that address an unmet medical need; medicines that may offer […]
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 […]
Clinical Trials Regulation in the EU
Clinical Trials Regulation in the EU The Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into application on 31 January 2022 and the Clinical Trials Information System (CTIS) is due to go live on this date. What are the aims of the new Clinical Trials Regulation? To create an environment that is favourable to conducting clinical trials in […]
Combined Review
Today we are looking at the combined review service; from 1 January 2022 all new Clinical Trials of Investigational Medicinal Product (CTIMP) applications will be submitted as combined review. Combined review means applicants only need to make a single application to both Research Ethics Committee (REC) and Medicines and Healthcare products Regulatory Agency (MHRA); the […]
PSURs/PBRERs – UK Processing
UK processing of PSURs/ PBRERs Today we are concluding our foray into the topic of Periodic Safety Update Reports (PSURs) and Periodic Benefit Risk Evaluation Reports (PBRERs) by focusing on how these are processed for medicinal products in the UK. Don’t forget to check out Today’s Top Tip below! How should I submit my PSUR […]