Form

Apply for a statement of exemption from the MHRA

Apply for a statement of exemption from the Medicines and Healthcare products Regulatory Agency (MHRA).

Documents

Apply for a medicinal product to be considered by the ACBS

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email publications@dhsc.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

To apply for a statement of exemption from the licensing and other provisions of the Human Medicines Regulations 2012 (as amended), download the application form, fill it in and send it to the Medicines and Healthcare products Regulatory Agency (MHRA), using the address provided below.

Alternatively you can email the form to borderline_medicine@mhra.gov.uk.

Medicines and Healthcare products Regulatory Agency address

Medicines and Healthcare products Regulatory Agency

Borderline Section
10 South Colonnade
Canary Wharf
London
E14 4PU

Published 12 April 2019
Last updated 14 November 2019 + show all updates
  1. The form and the page have been updated with a new return email address: borderline_medicine@mhra.gov.uk.

  2. First published.