UK MHRA Guidance: Medicines Marketing Authorisation: Change of Ownership

Sharan Murugan
Oct 5
3 min read

When the ownership of a medicine changes—through a merger, acquisition, corporate restructure, or divestiture—the marketing authorisation (MA) associated with that medicine must be legally transferred to the new holder. The UK MHRA provided an official guidance on 2 October 2025, outlining how to apply for a Change of Ownership.

Marketing Authorisation (MA): A regulatory licence that permits a medicinal product to be marketed. Also known in the UK as a product licence (PL).
Change of Ownership (CoA): The regulatory process by which responsibility for an MA is transferred from one company (the “transferor”) to another (the “transferee”).
Pharmacovigilance System / QPPV / PSMF: The safety monitoring framework, qualified person and master file associated with tracking a medicine’s safety post-market.

1. Apply to Change the Ownership of an MA

Under the guidance, either the current MA holder or the prospective new owner can initiate the application. The steps include:

Obtain a new PL number (product-licence number) if required by MHRA Submissions or by emailing PLNumberAllocation@mhra.gov.uk.
Complete the Change of Ownership application form. Each product generally needs its own form, though grouped products sharing a dossier may be submitted in the same sequence (with separate forms).
Submit via MHRA portal or Central European Systems Platform (CESP). Use the eCTD format for dossier structure.

All submissions must comply with eCTD standards.

2. Supporting Documents

The CoA application must include:

The completed application form.
Cover letter and justification.
Letter from the dosage form manufacturer (if applicable).
Cancellation letter from the current owner (if transfer is complete).
Declaration of marketing status (Annex 1) showing current product status, and intended changes.
Updated Patient Information (PI) leaflet and labelling reflecting the new owner and new licence number. The changes should be limited to ownership details; other changes may lead to invalidation.

If the pharmacovigilance system or QPPV is changing, supporting material must be included (or a plan for a Type IA(IN) variation post-transfer).

3. Supporting Information

After the change is granted, any further modifications to the pharmacovigilance system or safety reporting must be submitted as SPS updates or Type IA(IN) variations within 14 days.
If no changes are intended, the SPS must still be confirmed.
All documents should be signed appropriately by the transferee and transferor, and dated.

4. Processing Time

If the application is complete, MHRA aims to grant the Change of Ownership within 30 days (some published sources say within 42 days in absence of queries).
If MHRA issues a Validation Correction Request (VCR) (request for missing information), the applicant has 10 working days to respond. Failure to respond results in cancellation and full re-submission with new PL number.
Late or incomplete response may result in withdrawal of the application.

5. MA Expiry Date

The expiry date of the MA remains unchanged upon transfer.
Exception: If the remaining time on the MA is less than 6 months, the transferred MA must be granted with a minimum of 6 months validity.
All pending submissions (variations, renewals) will carry over under the new MA holder.

Transferring an MA is more than a paperwork exercise—it's about maintaining continuity of supply, upholding regulatory compliance, and ensuring that the public and healthcare professionals see correct ownership and liability information.

The UK MHRA guidance provides a clear framework for safely and legally transferring marketing authorisations between companies. By preparing the correct documents, anticipating responses to queries, and understanding the rules around expiry and safety systems, MA holders can ensure a smooth transition.