How Vape Products Are Notified To The MHRA
How Vape Products
Are Notified to
the MHRA
Every vape product legally sold in the UK has cleared a six-month MHRA notification process before hitting the shelf. Here is the full walkthrough of fees, timelines, testing requirements plus the ongoing reporting duties that follow approval.
Every new UK vape SKU must be notified to the MHRA at least six months before sale. The producer or importer submits a full product specification to the MHRA database covering ingredients, emissions testing data, stability testing, device specification plus packaging artwork. The notification fee is £150 per new SKU or £60 for a substantial amendment. Each flavour plus each nicotine strength counts as a separate SKU. Once the six months have elapsed the product can be placed on the UK market. Ongoing reporting continues every year for as long as the product remains on sale.
Three figures every
UK vape producer meets
Time, money plus data. Each of these three boxes has to be ticked for every SKU before a product legally reaches a UK retailer.
Minimum waiting period
The statutory window between submission and permitted first sale. The MHRA uses the window to review every submitted field.
Notification fee per SKU
Flat fee paid to the MHRA for every new submission. Amendments to existing notifications cost £60 each.
Data points per submission
The number of separate data fields a single submission must contain covering ingredients, emissions, device and packaging.
MHRA notification runs in six stages. Skip one and the SKU cannot be sold.
The MHRA notification process is not an approval in the pharmaceutical sense. It is a structured submission of product data that the regulator reviews against TPD compliance criteria. The process is the same for every producer whether a UK manufacturer launching a new flavour or an importer bringing a Chinese device to the UK. Six stages run in sequence. Missing any of them means the product cannot legally be placed on the UK market.
Stage 1: product specification
The submission starts with a full product specification. For a device this covers battery specifications, tank or pod capacity, airflow design, coil resistance plus refilling mechanism. For an e-liquid this covers every ingredient by CAS number, nicotine concentration, VG/PG ratio plus flavour compound suppliers. Every ingredient must be within the list of permitted substances set out in Schedule 1 of the TPD.
Stage 2: laboratory testing
Before submission the product has to pass laboratory testing at a UKAS-accredited facility. Testing covers:
- Emissions testing under standardised puffing protocols. Measurement of nicotine delivery plus presence of any regulated substances.
- Stability testing under accelerated ageing conditions. Confirms the product remains safe and consistent over shelf life.
- Leak and integrity testing for devices. Confirms no spillage during normal use, refilling or transport.
- Toxicological risk assessment covering every ingredient at exposure levels seen in normal use.
Testing costs typically run between £1,500 and £5,000 per SKU depending on complexity. Results are attached to the submission in the required format.
Stage 3: submission to the MHRA database
The submission goes in through the MHRA Submissions Portal. More than forty separate data fields have to be completed covering product identification, producer details, ingredient disclosure, emissions data, device specifications plus packaging artwork. Incomplete submissions are returned without processing which restarts the timeline.
Stage 4: fee payment
A £150 fee is paid per new SKU. A substantial amendment to an existing notified SKU costs £60. Fees are reviewed annually by the MHRA. Invoices are issued on submission with payment required within 30 days for the submission to move to review.
Stage 5: the six-month waiting period
Once the submission is accepted the regulator begins a six-month review. During this period:
- The product cannot be sold anywhere in the UK. Placing a non-notified product on the market is a criminal offence.
- The MHRA may raise queries about any field. Producers have a set response window to clarify or correct.
- The producer continues production planning in parallel. Stock is typically manufactured toward the end of the six-month window ready for launch.
- Retailers can view the pending notification but cannot list or advertise the product until approved.
Stage 6: permitted first sale and ongoing reporting
At the end of the six months the product can be placed on the UK market. The producer takes on ongoing duties:
- Annual reporting to the MHRA covering production volumes, sales data, any adverse event reports plus any substantial changes to the product.
- Notification of new variants. A new flavour or strength is a new SKU requiring its own full notification plus fee.
- Retention of test reports for at least six years for Trading Standards or MHRA inspection.
- Withdrawal notifications if a product is discontinued or recalled.
Four changes that trigger
a fresh MHRA submission
New flavour variant
Each new flavour is a new SKU regardless of brand. Raspberry Ice and Blueberry Ice from the same brand are two notifications not one.
New nicotine strength
A 10mg version of an existing 20mg flavour is a new SKU. Same bottle, different strength, separate notification.
Ingredient change
Swapping a supplier or changing a flavour compound triggers an amendment at minimum. A fundamental change may require a full new notification.
Device or hardware change
New coil, new pod design or revised battery spec is a new SKU. Even a new housing colour can trigger an amendment if packaging artwork changes substantially.
A successful MHRA submission vs
one that gets returned
Most MHRA notifications that stall fail on straightforward completeness issues rather than substantive product problems. Here is what separates a clean submission from one that restarts the clock.
Passes to six-month review
- ✓All 40+ data fields completed with no gaps or placeholders.
- ✓UKAS-accredited emissions report attached in the required format.
- ✓Stability testing report covering shelf life under accelerated ageing.
- ✓Every ingredient listed by CAS number with supplier details.
- ✓Packaging artwork attached showing 30% front plus back health warning.
- ✓Notification fee paid within 30 days of submission acceptance.
Timeline resets to zero
- ✗Missing data fields or placeholder text in required boxes.
- ✗Non-UKAS emissions report or report from unrecognised laboratory.
- ✗No stability testing at all or incomplete accelerated ageing data.
- ✗Ingredients listed by trade name only without chemical identification.
- ✗Artwork missing or health warning below 30% coverage.
- ✗Fee unpaid at the 30-day deadline. Submission archived without review.
MHRA notification is the compliance gateway behind every UK vape product. For the complete set of FAQs covering TPD, labelling, retailer duties plus the 2026 vape tax visit our vaping FAQs hub. Every major UK vape regulation question sits inside.
Back to the Vaping FAQs hub
This article sits inside our complete FAQs knowledge base. Head back to the hub for the full index covering MHRA rules, TPD, the 2025 disposable ban, the 2026 vape tax plus retailer compliance.
More on UK MHRA & TPD rules
Notification sits alongside the wider TPD framework plus labelling rules. Our guide on how TPD rules affect vape devices and e-liquids sets out the physical and ingredient limits every notified product must meet. Once a product has cleared notification the question most adult vapers ask is what it means if a vape product is MHRA compliant. For the labelling artwork side of submission our breakdown of what labelling and packaging rules apply to vapes is the working checklist every producer builds artwork against.