Register a Vape Product in the UK

With the vape market growing to almost $1.8bn in 2023, there is significant interest in registering a vape product in the UK. Here’s our guide on how to register a vape product in the UK.

Registering a vape product in the UK

The process for registering a vape product in the UK depends on a number of factors but a key factor is where the manufacturer is based.

Manufacturers based outside England, Scotland and Wales.

Manufacturers based outside England, Scotland and Wales with no office in these countries first need to acquire a UK Affiliate (click link to learn how we can help). This is a legal entity based in England, Scotland or Wales that has the knowledge and expertise to register your device on behalf of a non-UK manufacturer.

Manufacturers based in England, Scotland and Wales

Manufacturers based in England, Scotland and Wales do not need a UK Affiliate but may need the services of a consultancy to help register their vape products. Get in touch to learn about our services.

Compliance Check

Regardless of where the manufacturer is based, a thorough compliance check against the UK regulations is required. Any of the following regulations may apply:

• Tobacco & Related Products Regulations 2016 (transposed from EU Directive below)
• EU Tobacco Products Directive 2014/40/EU
• CLP Regulation (EC) No 1272/2008

The compliance check should be carried out by an experienced and knowledgeable regulatory professional. They will investigate the products characteristics, documentation and instructions for use, among other things. The review will take into account applicable regulations and identify any compliance issues. Provided the device and documentation is compliant with the regulations, the product can be taken to next step: registering the product with the MHRA, the UK regulator for vape products.

Looming Disposable vape ban

The UK government has recently publishing draft legislation on a disposable vape ban. This means some types of single-use vapes will be banned – it is not clear at this stage if pods and cartridges are included in the vape. More information to follow.

Register the vape product with the MHRA

Here are the steps to register a vape product with the MHRA (UK). Remember if you are not based in the UK you must assign a UK Affiliate to to be included in the registration.

1. Create an MHRA Account: Head to the MHRA website and create an account. Both the submitter and UK affiliate must be registered.
2. Assign UK Affiliate: If you require a UK Affiliate you must connect your account with theirs.
3. Register Your Product: Once logged in, you can start the registration process for your vape product. Build from existing EU TPD files or start from scratch.
4. Pay the Registration Fee: Before you can submit you must pay the notification fee of £150 per notification.
5. Submit Your Application: After making payment, the notification is submitted. You must wait around 2 – 6 months for the product to appear in the MHRA online database before you can market.

Maintenance of Registration

Once you submit the registration, the process does not end there. Submitters – or the UK Affiliate – are required to submit annual sales reports to MHRA. Manufacturers must also submit changes to the notification should any information change since submission.

Contact us today

Get in touch to learn more about registering a vape product in the UK and our affiliate services. Fill in the form below and we’ll get back to you.

Resources

Official EU Directive PDF