UK Generics – How to compare your product information to a reference product
What is a reference product? A reference product is an innovator Marketing Authorisation (MA) that is periodically referred to when updating the safety information in a generic licence. The chosen reference product forms part of the basis for a generic licence to be granted by the competent authority. Which products use a reference? Many generic […]
Decentralised Manufacturing
What is Decentralised Manufacturing (DM)? DM brings a new manufacturing model to the pharmaceutical industry whereby a central site supervises and controls one or more ‘decentralised’ sites located close to patients. These sites can perform various manufacturing and testing functions via two distinct routes: Point of Care (POC): products that are made near the patients, […]
Super-group vs Workshare variations – what are the differences?
The principle of Super-grouped and Workshare Variations is to make an “identical change(s)” to a number of difference licences via 1 Application form, 1 submission, & 1 Authority assessment. The aim being that it makes it easier to harmonise National MA dossiers across different EU Member States. Also to avoid duplication of work by national […]
Traditional Herbal Registration vs Food Supplement
Why register your product as a traditional herbal registration instead of a food supplement? Herbal products are available in various forms on the UK market. They can be a licensed medicine – either with a full standalone license or alternatively as a ‘traditional herbal medicine’. In the UK the traditional herbal registration (THR) scheme allows […]
Active Substance Master File procedure in the UK
What is an active substance master file? An active substance master file (ASMF) is a great way for an active substance manufacturer to retain confidential intellectual property on a substance, while still providing enough information to the marketing authorisation holder (MAH) to take full responsibility over their medicine. The format is based on the eCTD, […]
MHRA RegulatoryConnect
In May the MHRA presented a webinar regarding the new RegulatoryConnect portal. A recording of the webinar is available on the MHRA website. The MHRA goals for RegulatoryConnect are that it will provide more predictable regulatory pathways, with greater transparency and visibility for regulatory assessments to industry. What this means is that the portal access […]
Adding Regulatory Affairs to Employee Onboarding
The Missing Piece: Adding Regulatory Affairs to Employee Onboarding Throughout my career, I’ve made it a priority to integrate Regulatory Affairs (RA) into the onboarding programs of every company I’ve worked with. The basis for this passion is my belief that when the wider business understands RA’s role, our job becomes easier and fewer issues […]
Regulatory Intelligence Insights
What is Regulatory Intelligence? Just as we use social media to stay informed about current affairs and what’s going on locally, Regulatory Intelligence (RI) keeps pharmaceutical companies abreast of everything impacting their regulated landscape. It’s the systematic process of gathering, analysing, and applying regulatory information to ensure compliance and anticipate future changes. At the end […]
NIMAR update May 2025
Recap In response to Brexit, on 1st January 2022, the UK brought in NIMAR (Northern Ireland MHRA Authorised Route) as a new supply route for ensuring prescription only medicines (POMs) are available to Northern Ireland. Supplying medicines via NIMAR is essential on public health grounds and having this additional option for supply route means POMs […]
Type IA Variations – A Change to Annual Updates
What is the new process for Type IA Variations in the EU – Annual Reports? Following the implementation of the Delegated Regulation (EU) 2024/1701, on 1 January 2025, there are now changes to the process for submitting Type IA variations. If your Type IA variation was implemented in 2024: it may be submitted no later than […]