Medicines marketing authorisation: Change of ownership application
MHRA are making improvements to the change of ownership application (COA) process for medicines marketing authorisations (MA).
The Medicines and Healthcare products Regulatory Agency (MHRA) aim to grant all COAs within 42 days and, to ensure we provide an efficient and quick service for all applicants, we have made some changes to the process.
The application form now has advice to help fill in the COA form with a revised list of supporting documentation. By following this advice, applicants can avoid any issues or delays to processing their application.
If there are no outstanding issues that result in a request for further information (RFI), you can expect the COA to be granted within 30 days. Once an application is sent to MHRA, applicants can expect to hear from us within 30 days of receipt of the application.
For all applications made after 1 March 2016, the applicant will have 14 days to respond from the date of issue of the RFI letter. Change of ownership applications will be withdrawn and the full fee will be charged if applicants don’t respond to requests for information (RFI) within 14 days of the letter date.
Details
Contact MHRA if you do not hear from us about your application after 30 days.
For more information
Information about how to change the ownership from one marketing authorisation (MA) holder to another can be found here. The change of ownership application form can be found here.