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UK MHRA vs EU TPD notification: two routes compared

CompliancePublished 30 September 20269 min readBy the FLYTO Export Team
Rechargeable pod system prepared for UK MHRA and EU TPD notification

Selling vaping products into the UK and the EU looks like one compliance job. It is three. There is a filing route for Great Britain, a different one for each EU member state, and — since 2025 — a device-format rule that decides whether any of that paperwork matters. Distributors who treat all three as a single tick-box are the ones who end up with containers they cannot legally place.

This is a working comparison of the two notification routes as they stand in September 2026, with the deadlines that are actually moving.

The baseline is shared; almost nothing else is

The UK retained the EU's 2016 product rules when it left, through the Tobacco and Related Products Regulations 2016. That means the physical product standard is effectively identical on both sides of the Channel, which is convenient for a manufacturer and misleading for a distributor — because the product being the same makes it easy to assume the process is the same too.

Product standardUK (TRPR 2016)EU (TPD 2014/40/EU)
Maximum nicotine strength20 mg/ml20 mg/ml
Refill container limit10 ml10 ml
Tank / pod capacity limit2 ml (nicotine-containing)2 ml (nicotine-containing)
Age of sale18+18+ (varies nationally)
Notification required before saleYes — MHRAYes — per member state
Health warnings & labellingPrescribed text and surface sharePrescribed text, national language(s)

Everything below that last row is where the two routes diverge, and where your planning either holds or falls apart.

Route A — the UK: one filing, one register

The UK is the simpler route by a wide margin, and it is the one to model first if you are new to regulated markets. You notify the Medicines and Healthcare products Regulatory Agency once per product, the product is entered on a public register, and that single submission covers England, Scotland, Wales and Northern Ireland.

  • One submission, one authority. No per-nation filing, no translation set, no portfolio of national portals.
  • Per product, not per brand. Brand, flavour, strength and pack size each define a separate notification. This is where range breadth quietly becomes the biggest cost line.
  • Lead time before launch. Notification is a pre-market obligation, so the clock starts well before your first shipment lands — not after. Build it into the order timeline rather than discovering it at customs.
  • Technical file comes from the manufacturer. You file; the factory supplies the specification, e-liquid composition, emissions and toxicological testing, safety data sheets and battery transport documentation.

Three UK changes in the second half of 2026

These are live and dateable, and each one touches landed cost or route to market rather than the product itself:

DateChangeCommercial effect
1 October 2026Vaping Products Duty starts at £2.20 per 10 ml of e-liquidApplies to nicotine-free liquid as well as nicotine. Duty stamps and revised pricing systems required. This is a margin event, not a product event.
29 October 2026Age-of-sale rules extended to all vaping and nicotine products; free distribution restricted; promotional discounts and coupons restricted; vending machines prohibitedAffects sampling programmes, promotional pricing and unattended retail. Rework any trade promotion before it goes live.
Consultation closed 2 October 2026Consultation on packaging, appearance, flavour naming and point-of-sale display under the Tobacco and Vapes Act 2026Not law yet — the Act creates powers that need secondary legislation. Treat the direction of travel as confirmed and artwork as provisional.

Two things worth saying plainly about the UK. First, the Tobacco and Vapes Act 2026 received Royal Assent on 29 April 2026, but most of what it sets up is enabling power: the day-to-day rules have not changed yet, and the government has indicated staged implementation. Second, the generational tobacco ban that starts on 1 January 2027 applies to tobacco. It does not ban vaping products for that cohort.

The UK rule that actually decides your range

Since 1 June 2025, the sale and supply of single-use vapes is prohibited across England, Scotland, Wales and Northern Ireland — and the ban covers nicotine-free devices too. A device remains lawful only if it is rechargeable, refillable and fitted with a replaceable pod or coil. Everything else in this article is paperwork. This one is a gate.

Route B — the EU: 27 filings, not one

The EU looks like one market and files like twenty-seven. Article 20 of the Tobacco Products Directive makes notification a national obligation: you submit to the competent authority of each member state where you intend to place the product on the market. In practice that means separate portals, separate per-product fees, separate language requirements and, in several countries, a required lead time before your launch date.

There is no consolidated European submission, and no EU-wide approval that a distributor can point to. A product notified in Germany is not notified in France. Budget the filing effort per country and sequence your market entry accordingly — one or two markets done properly beats ten started badly.

Where the EU is heading, and where it is not yet

An EU-wide flavour ban and an EU-wide disposable ban are frequently reported as imminent. As of September 2026, neither exists in law. The revision process — informally TPD3 — ran a public consultation that closed on 14 August 2026, following the Commission's April 2026 evaluation of the existing framework. The indicative timetable for a legislative proposal is December 2026, and timing remains subject to change. Flavours, disposables, nicotine pouches, nicotine-free e-cigarettes, packaging and digital marketing are all in scope for policy options.

What that means operationally: plan against the rules that exist today, and treat the EU revision as a medium-term reason to hold flexible artwork and flexible formulations. A product range that can be renamed and repackaged at short notice is worth more than a forecast.

National divergence is already the real constraint

Because member states can act nationally on public health and environmental grounds, the practical map looks nothing like a single market. Status as at September 2026, to be confirmed per market before ordering:

PositionMarketsWhat it means for a range
Single-use sales bannedBelgium, France (EU); UK (outside the EU)Sealed devices out; rechargeable replaceable-pod formats only
Ban approved or in progressBulgaria, Austria, Ireland, Poland, SpainAssume the ban arrives within your inventory cycle
Flavour restricted to tobacco (and in some cases menthol)Netherlands, Denmark, Lithuania, Latvia, SloveniaFruit and dessert profiles are unlistable regardless of device format
Legal under standard TPD, taxed heavilyItaly, PortugalFormat legal; excise per ml materially changes retail price points
No sales ban, recycling obligationsGermanyRetail collection duties apply; product range otherwise open
Reclassified, licensed retail onlyAustriaRoute to market changes more than the product does

The deadline most buyers have not priced: 18 February 2027

This is the item we raise with every European buyer, because it is EU-wide, it is dated, and it is not a vape regulation at all. The EU Battery Regulation (EU) 2023/1542 requires portable batteries to be removable and replaceable by the end user, and that requirement applies from 18 February 2027.

A classic disposable has a lithium cell soldered into a sealed chassis. It cannot meet that requirement, and no notification, licence or national permission changes it. The consequence is that the sealed single-use device becomes effectively unplaceable across all 27 member states on that date — including in member states that have never introduced a disposable ban.

For a distributor, that reframes the question. It is no longer “which markets still allow disposables?” but “what does my range look like after February 2027, and can I get there without writing off this year's inventory?”

UK and EU side by side

 UKEU
AuthorityMHRA — single authorityCompetent authority per member state
Filings requiredOne per productOne per product per country
LanguageEnglishNational language(s)
FeesSingle fee schedulePer-country fees, set nationally
Lead time before launchSet pre-market periodVaries by authority; some require advance notice
Single-use deviceBanned since 1 June 2025Fragmented now; effectively excluded from 18 February 2027 by battery rules
Tax layerVaping Products Duty from 1 October 2026National excise, divergent and under revision
Who filesImporter / distributorImporter / distributor

What survives — and why format beats flavour

Read the two routes together and a shape appears. Across the UK and most of the EU, the format that stays lawful is rechargeable, refillable, with a replaceable pod or coil. Flavour rules are the volatile variable; device format is the settled one. Build the range on format and treat flavour as a localised layer you can re-cut per market.

A useful side effect: dual-chamber flavour separation is a function, not a device category. Two sealed reservoirs and a switching valve describe how flavour is separated, not whether the cell is soldered in. That technology transplants straight into a rechargeable chassis with a replaceable prefilled pod — which is exactly where compliant European demand is heading, and why the dual-chamber story survives the disposable crackdown intact.

Pre-order checklist

  1. Confirm whether your device is single-use by the destination's definition, not by your packaging.
  2. Confirm the current national position in every country you intend to sell into — not the EU average.
  3. Count your notifications honestly: flavours × strengths × pack sizes × countries.
  4. Request the full technical file and check the test reports are current and match the SKU.
  5. Book notification timing before you place the production order, not after.
  6. Check whether your format clears the 18 February 2027 battery requirement.
  7. Price the UK duty into your margin if you sell into Great Britain.
  8. Review trade promotions against the UK's October 2026 restrictions on discounts, coupons and free distribution.
  9. Keep artwork and flavour naming flexible — both are in active review on both sides.
  10. Get the compliance division of labour in writing: manufacturer supplies the file, you make the filing.

Our EU compliance checklist covers the document set line by line, and the wholesale page lists the pod and prefilled formats we supply for markets where single-use devices are no longer an option. If you are re-planning a European range around the February 2027 battery deadline, send us your target markets and current SKU list and we will map it against the format that clears them.

F
FLYTO Export Team

We manufacture dual-chamber vape pod systems and disposables in Shenzhen and supply licensed distributors across the EU and UK. Questions about sourcing? Send a trade enquiry.

Questions

UK and EU notification FAQ

Do I need a separate MHRA notification for every flavour and strength?
Yes. MHRA notification is per product, and a product means a specific brand, flavour, nicotine strength and pack size. Ten flavours at two strengths is twenty notifications, not two. The same logic applies in the EU under Article 20, which is why range breadth is far more expensive in regulatory terms than most buyers expect. Notification must be completed ahead of placing the product on the market, and the product appears on the public MHRA register once accepted.
Can I still sell single-use disposables in the UK?
Not if the device is single-use. Since 1 June 2025 the sale and supply of single-use vapes has been prohibited across England, Scotland, Wales and Northern Ireland, and the ban covers nicotine-free devices as well as nicotine ones. A device stays lawful only if it is rechargeable, refillable and fitted with a replaceable pod or coil. Devices that merely look like a disposable but carry a charging port and a swappable prefilled pod are sold in volume in the UK today; sealed devices with a soldered cell are not.
Does one EU notification cover all 27 member states?
No. Under Article 20 of the Tobacco Products Directive the notification obligation is national: you file with the competent authority of each member state in which you intend to place the product on the market, usually through that country's own portal, in that country's language and on payment of that country's per-product fee. There is no single European filing. Plan the notification timetable per country, because some authorities require submission a set period before your launch date.
What happens to disposable vapes on 18 February 2027?
The EU Battery Regulation (EU) 2023/1542 requires portable batteries to be removable and replaceable by the end user, and that requirement applies from 18 February 2027. A sealed device whose lithium cell is soldered into the chassis cannot meet it. The practical effect is that classic single-use devices become unplaceable across the whole EU on that date, including in member states that have not introduced a national disposable ban. Confirm the current position for your specific market before committing to inventory.
Who is responsible for notification, the manufacturer or the importer?
The importer or distributor established in the market is the party that files. The manufacturer supplies the technical file the filing depends on: product specification, e-liquid composition with CAS numbers, emissions and non-clinical testing, safety data sheets, UN38.3 and the CE / RoHS / WEEE declarations. Any supplier claiming to have “done the compliance” for you is almost always referring to that file rather than to the in-country submission, which they are not positioned to make on your behalf.

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