Change of Ownership of Medicines Marketing Authorisation in the UK

1. Introduction

In the United Kingdom, when the ownership of a marketing authorisation (MA) – also referred to as a product licence (PL) – changes due to business transactions such as mergers, acquisitions or restructuring, the responsibility for that MA must be formally transferred to the new legal holder. This process is governed by guidance issued by the Medicines and Healthcare products Regulatory Agency (MHRA). Source: Medicines marketing authorisation: change of ownership (gov.uk) ([GOV.UK][1])

The change of ownership process ensures continuity of regulatory oversight, uninterrupted supply to patients, and ongoing compliance with quality, safety, and efficacy obligations. Source: UK MHRA Guidance: Medicines Marketing Authorisation Change of Ownership ([Regulatory Affairs][2])

2. Applying to Change Ownership

2.1 Starting the application

To begin a change of ownership (CoA), the current MA holder or the incoming owner must prepare an application in accordance with MHRA requirements. The first step is to obtain or confirm a product licence (PL) number through MHRA Submissions or by email to the designated MHRA allocation service. Source: Medicines marketing authorisation: change of ownership (gov.uk) ([GOV.UK][1])

Completing the official change of ownership form is mandatory for each product being transferred. If multiple products share the same dossier, they may be submitted together, but each still requires its own form within the dossier structure. Source: Medicines marketing authorisation: change of ownership application (gov.uk) ([GOV.UK][3])

2.2 Submission channels and standards

Applications can be submitted via the MHRA portal or the Central European Systems Platform (CESP). All dossiers must comply with electronic Common Technical Document (eCTD) format standards to facilitate processing. Source: Medicines marketing authorisation: change of ownership (gov.uk) ([GOV.UK][1])

Supporting documentation should be included per guidance, ensuring the application is complete and correctly structured for review. Source: UK MHRA Guidance: Medicines Marketing Authorisation Change of Ownership ([Regulatory Affairs][2])

3. Documentation and Supporting Information

A change of ownership submission typically includes:

• The completed application form for change of ownership, specific to each product licence.
• A cover letter explaining the transaction and intent for transfer.
• A declaration of marketing status specific to the products being transferred.
• Updated patient information leaflet (PI) and label reflecting the new MA holder details.
• Where applicable, updated pharmacovigilance information including changes to the Qualified Person Responsible for Pharmacovigilance (QPPV) and Pharmacovigilance System Master File (PSMF). Source: UK MHRA Guidance: Medicines Marketing Authorisation Change of Ownership ([Regulatory Affairs][4])

4. Processing and Timelines

The MHRA processes change of ownership applications upon receipt of a valid submission. Historically, applicants could expect a response or grant of the change within a set timeline (for example within 30 calendar days) if no additional information was requested. Source: Medicines marketing authorisation: Change of ownership application process (gov.uk news archive) ([GOV.UK][5])

If the MHRA requests further information, applicants are typically given a period (e.g., 14 days) to respond; failure to do so can result in withdrawal of the application and forfeiture of fees. Source: Medicines marketing authorisation: Change of ownership application process (gov.uk news archive) ([GOV.UK][5])

5. Regulatory Implications of Ownership Change

Upon successful transfer of ownership, the new MA holder assumes all regulatory responsibilities associated with the product licence, including:

• Ongoing compliance with reporting obligations and safety monitoring.
• Maintenance of quality standards aligned with the original authorisation.
• Notification of any subsequent changes to marketing authorisation details, which may require variation submissions. Source: UK MHRA Guidance: Medicines Marketing Authorisation Change of Ownership ([Regulatory Affairs][2])

Effective change of ownership maintains regulatory continuity and ensures the continued lawful supply of medicines within the UK market. Source: Medicines marketing authorisation: change of ownership (gov.uk) ([GOV.UK][1])

6. Practical Considerations

It is recommended that companies undergoing a change of ownership plan early and coordinate closely with regulatory, legal, and quality teams to prepare comprehensive documentation and ensure timely submission. Proper planning helps avoid delays in authorisation transfer and potential market supply interruptions. Source: Change of Ownership | Post Approval | Regulatory Services ([cambreg.co.uk][6])