Request advice on the status of a borderline medicinal product

Use this form to request advice from the Medicines Borderline Section on a medicinal product.

Read this important information before continuing

Before completing this form you should read our Guidance Note 8 - A Guide to What is a Medicinal Product (opens in new tab). This document details important information including what borderline products are, the different categories of product and the deciding factors used when determining the regulatory status of a product.

Completing this form

You should provide as much information as possible about your product. This will enable the Medicines and Healthcare products Regulatory Agency (MHRA) to consider what the product is, why it will be used by consumers, how it will be promoted and what effects it may have.

What sort of advice will you receive from MHRA?

The response you receive to this request will be an opinion as to whether your product is deemed to be a medicinal product, or not. This opinion is based on the information you provide and will not constitute a legal determination.

If our opinion is that your product is a medicinal product, we will provide advice on the necessary steps to obtain authority to sell it in the UK.

If our opinion is that your product is not a medicinal product, this does not give you any kind of approval to sell, supply, or advertise it in the UK. Only the applicable regulatory authority can give that approval.

How long will it take to get your advice?

The MHRA will endeavour to provide an opinion within 28 days from receipt of a completed form.

Before you start

You must not:

• Use this form for Part XV Drug Tariff applications. These applications are made to the Advisory Committee on Borderline Substances (opens in new tab)
• Submit details of more than 4 products, unless requested to do so

To complete the form, you will need:

• Your own contact details
• Information about your product and how it works
• Claims, wording or graphics used to promote and advertise your product. You will be required to upload files or documents to demonstrate these
• Information about where and how the product will be advertised