UK MHRA: Guidance on Change of Ownership: Marketing Authorisation Process

Last Friday (17 November 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Medicines Marketing Authorisation: Change of Ownership" that provides guidance on How to change the ownership from one marketing authorisation (MA) holder to another.

Change of ownership in the pharmaceutical sector refers to the transfer of responsibility for a medicinal product's marketing authorization from one company to another. This could occur due to mergers, acquisitions, divestitures, or other business transactions.

Ensuring a smooth transition in such cases is crucial to maintaining the continuous supply of essential medicines and safeguarding public health.

The MHRA provides clear guidance on the change of ownership process through its regulatory framework. Companies undergoing a change in ownership must comply with the applicable legal requirements outlined by the MHRA. It is essential for both the transferring and acquiring companies to work closely with the MHRA to ensure a seamless transition without compromising the quality, safety, and efficacy of medicinal product.

Change of Ownership Submission must include:

1. The Application Form

2. A cover letter

3. A Letter from Dosage Form Manufacturer

4. A cancellation letter

5. Annex 1 – Declaration of marketing status for Change of ownership.

6. The Patient Information (PI) - leaflet and label

In the case of a change of ownership, changes to the pharmacovigilance system and/or the UK-qualified person responsible for pharmacovigilance (QPPV) may be made during the COA application process or as a Type IA(IN) variation.

The application can take up to 42 days to process during which MHRA may contact the applicant with a Validation Correction Request (VCR) for information. In cases where the MA has less than 6 months left, a minimum period of 6 months will be given before the expiration date changes.

Click this LINK to learn more about the requirements and how to apply to change the ownership of an MA.

Also, check out this guidance on the qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) that was released on 17 November, 2023 which details Pharmacovigilance system requirements.