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Headquarters:
regenold GmbH
Zöllinplatz 4
79410 Badenweiler
Germany
Phone: +49 7632 82 26-0
Fax: +49 7632 82 26-555
Email:
info@regenold.com
Anna Johnstone
Principal Regulatory Officer
Anna is a highly experienced Regulatory Officer with over 16 years in the pharmaceutical industry. She brings extensive knowledge in clinical safety, with a particular focus on the reclassification of medicines in the UK.
Before transitioning into the pharmaceutical sector, Anna trained and worked as a Pharmacy Technician for more than five years. Her hands-on experience within the NHS, working directly with healthcare professionals and patients, provides her with valuable practical insight.
Throughout her career, Anna has developed deep expertise in managing Marketing Authorisation (MA) maintenance activities, delivering medicines information services, and crafting strategic approaches for complex regulatory submissions.
She supports clients to ensure claims and advertising remain competitive but compliant across a range of products, including prescription and over-the-counter medicines, medical devices, cosmetics, and food supplements.
Anna specialises in the development and submission of medicine reclassification applications in the UK, guiding clients through scientific advice procedures and regulatory pathways. She has successfully led multiple switch applications during her time at regenold.
As a member of TOPRA and an active participant in PAGB working groups, Anna stays up to date with the latest regulatory developments – ensuring her clients benefit from current, informed guidance.
Simplifying the Journey from Prescription to Over-the-Counter: How regenold Supports Successful Medicine Reclassification
The UK healthcare landscape is evolving rapidly. As set out in the NHS England "10 Year Health Plan", the service is shifting from hospital-based care to more community, home and digital delivery; empowering patients to manage their care more seamlessly; and moving from treating sickness to preventing it.
In that context, medicine reclassification – the transition of treatments from prescription-only to more accessible pharmacy or over-the-counter status – plays a key role. It supports self-care, helps reduce demand on primary and secondary care services, and aligns with the NHS's ambition to make the healthy choice the easy choice.
A Proven Track Record in Reclassification
At regenold we believe that better health starts with better access. Our work in medicine reclassification – helping companies transition medicines from prescription (Rx) to over-the-counter (OTC) status – is all about enabling patients to manage their own health safely and effectively.
Our team combines deep regulatory knowledge with commercial insight. In 2025, we supported nine UK Scientific Advice Meetings and five successful reclassification applications across multiple therapeutic areas, including topical antipsoriatics, vitamin D formulations, urologicals (erectile dysfunction), urinary antibacterial agents, nasal corticosteroids and combination treatments, and ophthalmological anti-infectives.
We understand what the MHRA looks for and how to navigate the regulatory expectations for both branding and hybrid brand/generic products.
From Strategy to Submission
Our reclassification services cover every stage of the process.
Scientific Advice Meetings (SAMs)
We prepare robust documentation to gain early MHRA feedback, reducing the risk of rejection later. Our in-house experts support all required Risk Management Plans (RMPs) and Risk Minimisation Measures (RMMs) to ensure product safety is at the heart of every application.
Justification Statements
Our experienced writers draft comprehensive, data-driven documents with clarity and precision. We partner with marketing specialists to build strong brand identities and commercial strategies that align with the regulatory pathway.
Insight Through Collaboration
As associate members of PAGB, we leverage international insight and a strong external network – including former MHRA assessors – to ensure our clients benefit from the latest trends, best practices, and regulatory expectations.
The Bigger Picture: Supporting Self-Care
The Department of Health and Social Care (DHSC) continues to encourage more self-care opportunities through reclassification, with recent focus areas including acne, eczema, and psoriasis. We see this as a sign of growing support for innovation and accessibility – creating exciting opportunities across new therapeutic categories such as antifungals.
Tailored Support, Every Step of the Way
Every client's needs are different. That's why we offer bespoke service packages, providing as much or as little support as required – from initial feasibility assessments to full end-to-end project delivery.
If you're considering a reclassification and want to understand the commercial and regulatory pathway, get in touch with our expert team who are here to help you simplify the journey from innovation to the marketplace.
Insights
Considering a Reclassification?
Our expert team can help you understand the commercial and regulatory pathway and simplify the journey from innovation to the marketplace.
Speak with an Expert