Medicines marketing authorisation: change of ownership
How to change the ownership from one marketing authorisation (MA) holder to another.
Official website: gov.uk00
How to use the service
If you are applying for a UK, Great Britain or Northern Ireland licence, you must get a PL number from MHRA Submissions or by emailing PLNumberAllocation@mhra.gov.uk before you submit your application. Please note the following prefixes and their definitions: PL: a product licensed by the MHRA that covers the whole of the UK, coming into effect from 1 January 2025. Please see more information in the following guidance: UK-wide licensing for human medicines - GOV.UK PLNI: a product licensed by the MHRA that covers Northern Ireland (NI) only as the territorial application. PLGB: a product licensed by the MHRA that covers Great Britain (GB) only as the territorial application Complete the change of ownership form and send it via Central European Systems Platform (CESP) with the supporting documents . Applications can also be submitted via the MHRA portal . You will need to register if you haven’t already. You need to follow the eCTD standards when submitting your application.
Processing time
The application can take up to 42 days to process during which we may contact you with a Validation Correction Request (VCR) for information. If you wish to receive electronic communication (eCOMMS) and is not yet registered please send a request to Reference.Data@mhra.gov.uk , including the company details and a suitable email address. If you don’t respond within 10 working days we will cancel your application and you will be charged the full fee. You will need to re-submit your application using a new PL number. You may send the response via the same route of submission you initially submitted your COA. No extensions to the VCR deadline will be provided. You may contact the MHRA by email RIS.NA@mhra.gov.uk if a grant or request for information letter has not been received by the 25th day from the date the application was submitted.
Official source
Medicines marketing authorisation: change of ownership
retrieved: