What is the MHRA and why it matters for vapes

What the MHRA actually does

The Medicines and Healthcare products Regulatory Agency is an executive agency of the UK government, sitting under the Department of Health and Social Care. Its main job is regulating medicines, medical devices and blood components in the UK.

For vapers, the relevant part of the MHRA's work is its role as the competent authority for nicotine-containing vaping products under the TRPR 2016. Every nicotine vape product on sale in the UK has been through an MHRA process before reaching the shelf.

The MHRA is not the agency that decides if vaping is good or bad public policy. That is up to Parliament and the Department of Health. The MHRA's job is more technical: making sure individual products meet the legal standards before they can be sold.

How the MHRA notification process works

Before any new nicotine vape product can be sold in the UK, the manufacturer or importer must submit a notification to the MHRA. This is not the same as a medicines licence (which is much more rigorous). It is a notification scheme, which means the producer is registering the product and declaring it meets the rules, with the MHRA carrying out checks.

1. Submit through the MHRA Submission Portal

   The producer (manufacturer, importer or rebrander) submits details of the product through the official portal. This includes ingredient lists, emissions data, manufacturing details, packaging artwork and intended marketing.

2. Pay the notification fee

   Each new product attracts a fee. The MHRA is partially funded through industry fees, which keeps it independent of government budget pressure.

3. MHRA reviews the submission

   Checks the product meets all TRPR requirements. Verifies the ingredient list, emissions testing results and toxicological assessment.

4. Wait 6 months

   Mandatory standstill period. The product cannot be sold until at least 6 months after a complete notification has been submitted, regardless of approval status.

5. Product appears on the public database

   Once approved, the product is added to the MHRA E-Cigarette Notified Products List, with a unique EC-ID. Only then is it legal to sell in the UK.

6. Ongoing compliance monitoring

   The MHRA can request additional information at any time, investigate complaints and withdraw products from sale if problems emerge.

The Yellow Card system

One of the most useful tools the MHRA runs is the Yellow Card system. This is how anyone (vaper, retailer, healthcare professional) can report a suspected adverse event from a vape product.

The Yellow Card system was originally developed in the 1960s for reporting side effects of medicines. It now covers medical devices, medicinal products and, since the TRPR 2016, vape products.

Searching the MHRA database

The MHRA maintains a publicly searchable database of every notified vape product. You can use it to verify whether a specific product is registered. Useful if you are unsure about a brand or worried about an import.

1. Go to the MHRA E-Cigarette Notified Products List

   Available on the gov.uk website. Updated regularly with newly notified products.

2. Search by brand or product name

   You can also search by EC-ID if you have it from the packaging.

3. Check the details

   The listing shows the product name, manufacturer, EC-ID, status (active or withdrawn) and submission dates.

4. If the product is not there, it is not legal

   A product that should be notified but is not, cannot legally be sold in the UK. If you have bought one, you can report it to Trading Standards.

What the MHRA does not do

The MHRA's role is sometimes misunderstood. Worth being clear about what it does not do.

• The MHRA does not pre-approve every batch. It approves the product based on submitted information. Ongoing batch quality is the manufacturer's responsibility.
• The MHRA does not certify a product as “safe” in absolute terms. It confirms the product meets the legal standards, which is different from saying it is risk-free.
• The MHRA does not write the rules. Parliament writes the law via the TRPR and related legislation. The MHRA enforces what is on the statute book.
• The MHRA does not handle every consumer complaint. Day-to-day enforcement happens at the local Trading Standards level. The MHRA handles regulatory and product-safety issues.
• The MHRA does not regulate nicotine-free vape products in the same way. Those fall under general product safety law.
• The MHRA does not regulate vape advertising. That is the Advertising Standards Authority (ASA).

Why this matters for consumers

Most vapers never directly interact with the MHRA. But its work shapes what you see on the shelf in several important ways.

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