Please use this form to request advice from the Medicines Borderline Section on a medicinal product only and email along with any attachments to email@example.com
Before completing this form you should read our Guidance Note 8 - "A Guide to What is a Medicinal Product where you may find the information that you need.
The response you receive to this request will provide an opinion only as to whether or not your product would be deemed a medicinal product and if so, advice on what steps would be necessary to obtain authority to sell it in the UK. This will be based upon the information provided by you and will not constitute a legal determination. An opinion that your product is not a medicine does provide an approval to sell, supply or advertise the product in the UK. This can only be given by the authority that will be responsible for its regulation.
When completing this form you should provide as much information as possible about your product. This will enable the MHRA to consider what the product will be used for, why it will be used by consumers, how it will be promoted and what effects it may have.
The MHRA will endeavour to provide an opinion within 28 days from receipt of this form. If you have not received a reply within this period, please let us know by email to firstname.lastname@example.org. Please do not submit details of more than 4 products unless requested to do so.
Please do not use this form for Part XV Drug Tariff applications which are made to the Advisory Committee on Borderline Substances (ACBS)
I confirm that I have read the notes above:
*Confirm email address
*Nature of company's business, e.g. manufacturer, wholesaler, distributor, retailer
Product form, e.g tablet, capsule, cream, plaster etc.
Ingredients - (Please include details of the amount of each ingredient. If the ingredient is herbal please give the botanical name and the part of the plant being used.)
Excipients (i.e. non-active ingredients such as preservatives, flavourings etc.)
For what purpose will a consumer use the product?
How does the product work?
Is the product already on sale? If so please provide details
Where will the product be sold? e.g. website, pharmacy, supermarket, health-store, independent online retailer
Please give the actual or intended wording and details of any graphics used to promote the product on it's labelling, packaging and promotional material including websites. (If necessary submit as an attachment)
Details of health claims used under Regulations (EC) No 1924/2006
If no claims are to be made for the product, please explain how a consumer will understand its purpose and how it is to be used
Please provide copies of any advertising together with details of any social media sites where the product will be promoted
Thank you for completing this advice request form. Please submit this by clicking below. Any additional attachments should be sent to email@example.com using the product name as a subject line.