Please use this form to request advice from the Medicines Borderline Section on potentially medicinal products.
When you send your completed form you will receive an auto response to confirm that your submission has been received. Due to other priority work we are unable to give you a timescale as to when we shall be able to reply and this may be several months. We therefore advise that you read the Agency's ‘A guide to what is a medicinal product’
This provides clear and concise information, which you may find provides the advice you need. In Appendix 2 you will find contact details for other organisations that may be able to assist you. If, after reading this information you feel you still require advice please confirm this with a further e-mail to firstname.lastname@example.org.
If we do not receive further confirmation from you within 2 weeks from the date of the initial form submission we will assume that further advice is not required.
Please be aware that submitting requests for advice on several products may cause further delays in our ability to respond. For this reason we will normally limit our initial response to a maximum of 3 products only. Any additional products are likely to be considered separately and at a later date depending on available resources Enquiries, including enquires about medical devices and the legislation which applies to medical devices should be made to 020 3080 6000. Please do not use this form for requests to the Advisory Committee on Borderline Substances (ACBS).
Please note that it is the responsibility of those placing a product on the market to ensure it meets legal requirements. The absence of a response from the MHRA does not constitute an acceptance that the product is not a medicinal product.
All fields must be completed to avoid a delay in processing.
*Confirm email address
Product form, e.g tablet, capsule, cream etc.
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.
Purpose of product
Product's mode of action
Please give the actual text or wording used to promote the product
Website address where the product is or will be promoted
Note - Opinion will only be based on the information provided.
Email any additional attachments to email@example.com after submitting this form.