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What MHRA's January updates mean for your business

Welcome to our weekly newsletter. Each week we will share practical regulatory updates with a clear focus on what changed, why it matters, and what teams should do next.

Borderline products: how MHRA decides if your product is a medicine

The MHRA borderline products guidance was last updated on 12 January 2026. (GOV.UK) It is a useful reset for any product that could sit between medicines, devices, cosmetics, supplements, herbals, or biocides.

The MHRA borderline products guidance was last updated on 12 January 2026. (GOV.UK) It is a useful reset for any product that could sit between medicines, devices, cosmetics, supplements, herbals, or biocides.

What MHRA is reinforcing

  • Claims and overall presentation drive outcomes. MHRA looks at the full picture, including labels, packaging, websites, and promotional content. A product can be treated as a medicine even if it looks like a cosmetic or supplement, if the presentation points toward prevention or treatment of disease. 
  • Mode of action is a major lever. If the intended primary effect is achieved via pharmacological, immunological, or metabolic action, the product is more likely to fall under medicines regulation.
  • “It is classified differently in another country” does not settle the UK position. MHRA assesses against UK legal definitions and the evidence in front of them. 

What you can do this week

  • Run a quick internal check on your claim set: do any phrases imply diagnosis, prevention, treatment, relief, or cure?
  • Stress test your “how it works” narrative: does it imply a pharmacological or metabolic effect even indirectly?
  • If the product is truly borderline, plan early for the right pathway and evidence strategy, before brand and marketing materials become expensive to unwind. 

UK medical devices: January 2026 guidance refresh that affects UKCA planning, registration, and study timelines

Several core GOV.UK device guidance were refreshed in January 2026, and together they clarify the stepwise route to market and the common traps that cause delay.

Key updates worth actioning

  • UKCA conformity assessment guidance was last updated on 15 January 2026, including an updated conformity assessment flowchart. This is central for mapping classification to the correct conformity route for Great Britain, with separate rules for Northern Ireland (CE / CE UKNI). (GOV.UK)
  • Device registration guidance was last updated on 16 January 2026 and highlights operational changes: registration sits alongside conformity assessment (it is not an approval), and new registration fee management is being implemented. The guidance indicates an estimated annual fee from 1 April 2026 in the region of GBP 300 per year per Level 2 GMDN category, plus practical account management implications for continuing to place devices on the market after that date. (GOV.UK)
  • Clinical investigations guidance was last updated on 14 January 2026 and repeats a planning critical: where notification is required, you must inform MHRA at least 60 days before starting the investigation. It also notes that notification is not required for devices already UKCA, CE, or CE UKNI marked for the purpose under investigation. (GOV.UK)
  • Health Institution Exemption guidance was last updated on 20 January 2026 and provides scenario-based expectations for health institutions manufacturing or modifying devices for internal use, including clarifications on transfer and use outside the institution’s premises. (GOV.UK)

What this means for your 2026 plan

  • Build your strategy in the right order: confirm classification and conformity route, lock the evidence plan (including any clinical investigation timeline), then manage registration and readiness for the April 2026 fee model.
  • If you work with hospitals, software, or internally manufactured devices, sanity check whether the Health Institution Exemption logic is being relied on appropriately and document the rationale early.

If you would like a rapid, authority aligned sense check on your classification, regulatory pathway, or submission approach, Assure Regulatory Services (ARS) can support with UK and EU regulatory strategy and execution, dossier and submission delivery, and lifecycle management activities, with broader global support outside EU where needed. Please reach out at info@assureregulatoryservices.com and we will advise the most efficient next step. For further details you can also visit our website www.assureregulatoryservices.com.


EU/UK Cosmetics after Brexit + MHRA Action on Illegal Weight-Loss Jabs

Welcome to the Assure Newsletter. We will share a concise selection of regulatory developments and guidance updates, with clear takeaways on what they mean for compliance strategy, submission readiness, and risk management. The goal is to help you stay ahead of emerging expectations, reduce avoidable authority questions, and make faster, better-informed regulatory decisions.

EU & UK Cosmetics After Brexit: Similar Framework, Separate Systems 

For many cosmetic brands, EU and UK requirements still feel largely aligned and in several areas they are. Great Britain’s framework is rooted in the same legal foundations that governed the UK pre-Brexit, and the underlying principles remain familiar: products must be safe for human health, manufactured under appropriate controls (GMP remains a practical benchmark), and supported by a Product Information File (PIF) with a robust safety assessment.

Where brands get caught out is not the science, it’s the structure. Post-Brexit, the UK and EU now run on separate legal responsibilities, separate notification systems, and (often) separate packaging logistics. What used to be a single operational pathway is now a dual-track compliance model.

The practical differences that create delays

1. Responsible Person (RP): the legal anchor point

  • In Great Britain (England, Scotland, Wales), products must have a UK-based Responsible Person.
  • In the EU (and Northern Ireland), products must have an EU/NI-based Responsible Person.
    This means a single RP cannot cover both markets anymore. For many companies, that introduces a new set of contracts, handovers, and ongoing maintenance responsibilities.

2. PIF: one dossier in principle, but held per jurisdiction

The encouraging part is that the core PIF content can typically be maintained as one master dossier the “same technical story” can support both markets. However, operationally the file must be held and maintained by the RP in each jurisdiction, and be readily available to the relevant authorities.

3. CPSR: content aligned, signature expectations can still trip you

Even when you have an EU-ready safety assessment, Great Britain requires the safety assessment to be signed by a UK-based professional. This is a common pinch point because brands often discover it late, after they’ve built the EU file and assumed the UK follows automatically.

4. Notification: one product, two portals

Before Brexit, notification through the EU portal supported broad market access. Now:

  • EU/NI notification is via CPNP
  • GB notification is via SCPN
    That means separate submissions, separate ownership, and separate system readiness, particularly important when multiple SKUs or frequent updates are involved.

5. Labelling: the “small” change that becomes a big supply-chain decision

One of the most operationally disruptive shifts is the RP address requirement:

  • Great Britain packaging must show the UK RP name/address
  • EU packaging must show the EU RP name/address
    Depending on your packaging setup, you may need separate labels and SKUs, or a carefully designed dual-labelling strategy that is controlled and consistently executed.

Why this matters (practical implications)

  • Avoid timeline drift: late RP appointment, late UK CPSR sign-off, or late portal notification planning can add weeks.
  • Reduce relabelling risk: packaging decisions impact costs, lead times, and inventory complexity (especially if you serve both EU and GB from one supply chain).
  • Prevent “right-first-time” failures: documentation may be aligned, but ownership and location requirements are not, authorities expect jurisdictional accountability.
  • Strengthen governance: dual systems increase the need for document control, version management, and clear responsibility matrices (who holds what, where, and who updates it).
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MHRA raids: ~2,000 doses of illegal weight-loss “jabs” seized

High demand is accelerating counterfeit supply chains — and enforcement is visibly stepping up.

Britain’s medicines regulator, the MHRA, has intensified its actions against criminal networks linked to unlicensed and illegal weight-loss injectables. In an operation announced on 25 February 2026, raids at two locations in Lincolnshire and Nottinghamshire resulted in the seizure of almost 2,000 doses of suspected illegal products, along with manufacturing equipment, packaging materials, and commercial vehicles.

What stands out is that this wasn’t just a case of illegal resale — the presence of equipment and packaging indicates manufacturing or assembly activity and a structured operation designed to move products through informal channels.

1. What was reportedly found

Items seized were labelled as containing tirzepatide and retatrutide:

  • Tirzepatide is a legitimate active ingredient in approved therapies (making it attractive to counterfeiters).
  • Retatrutide is investigational, still in clinical development, and its appearance in counterfeit labelling reflects how criminals exploit “next-generation” pipeline narratives to create market demand for unlicensed products.

The February operation follows another major action reported in October 2025, when the MHRA described dismantling an illicit facility linked to unlicensed weight-loss medicines, indicating this is a sustained enforcement theme rather than a one-off raid.

2. Why this is happening now

This trend is being driven by a familiar combination:

  • High patient demand for obesity treatments
  • Restricted access pathways through formal systems
  • High private costs, pushing some consumers toward online and informal supply channels
  • The speed of “viral” health trends, which criminal networks can exploit faster than public awareness catches up

Why this matters (practical implications)

  • Brand and patient safety risk: falsified medicines can contain the wrong dose, contaminants, or no active ingredient and adverse events often get associated with the “real” category or brand in public perception.
  • PV and complaint handling pressure: companies should ensure robust triage for suspected falsified products, clear escalation routes, and consistent documentation for authority engagement where appropriate.
  • Supply chain expectations will tighten: high-demand therapeutic areas may see increased scrutiny on distribution controls, track-and-trace measures, anti-tamper features, and investigation readiness.
  • External communications matter: clear patient-facing guidance on authorised supply routes and “how to verify legitimacy” can reduce harm and reduce noise in complaint channels

If you would like a rapid, authority aligned sense check on your classification, regulatory pathway, or submission approach, Assure Regulatory Services (ARS) can support with UK and EU regulatory strategy and execution, dossier and submission delivery, and lifecycle management activities, with broader global support outside EU where needed. Please reach out at info@assureregulatoryservices.com and we will advise the most efficient next step. For further details you can also visit our website www.assureregulatoryservices.com.