Form

Medicines marketing authorisation: change of ownership application

Use this form to transfer a product licence, also known as a marketing authorisation, to a different owner.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 December 2014
• Last updated: 25 February 2019 — See all updates

Documents

Application form to change the ownership of a product licence

MS Word Document, 82 KB

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Annex 1: declaring marketing status when change of ownership of a product licence

MS Word Document, 55 KB

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If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email [email protected]. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

Complete the change of ownership application form and submit it with the supporting documents below via the MHRA portal. You will need to register if you haven’t already.

Submissions can also be made via the Central European System Platform (CESP)

You need to submit separate applications for each legal category listed on the current marketing authorisation if they are being carried over.

You will need to pay a fee of £442 before submitting your application ensuring you provide proof of payment. You also need to request an application number for all documents by emailing us beforehand [email protected]. Include your company name and address or the company number issued by MHRA if you’re the current owner.

See the guide for transferring ownership for details of what to include.

Published 18 December 2014
Last updated 25 February 2019 + show all updates

1. 25 February 2019

   Attached new change of ownership form

2. 18 April 2016

   New 2016 form uploaded

3. 25 February 2016

   Revision of application form for a change of ownership for a Medicines marketing authorisation.

4. 18 December 2014

   First published.