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).

• From: Department of Health and Social Care
• Published: 12 April 2019
• Last updated: 14 November 2019 — See all updates

Documents

Apply for a medicinal product to be considered by the ACBS

MS Word Document, 76 KB

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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. 14 November 2019

   The form and the page have been updated with a new return email address: borderline_medicine@mhra.gov.uk.

2. 12 April 2019

   First published.