Medicines marketing authorisation: change of ownership
- Medicines and Healthcare products Regulatory Agency
- Part of:
- Transfer ownership of a marketing authorisation for medicines, Patient safety, and Marketing authorisations, variations and licensing guidance
- First published:
- 18 December 2014
- Last updated:
- 18 April 2016, see all updates
How to change the ownership from one marketing authorisation (MA) holder to another.
You need to apply for a change of ownership to transfer a marketing authorisation (MA), also known as a product licence, to a new owner. You can do this as the current or new owner as long as the required documents are submitted with the form.
Apply to change the ownership of an MA
You will need to pay a fee of £442 before submitting your application. You will need to make sure you provide proof of payment with your application. You also need to request an application number for all documents by emailing us beforehand on Area0-PLNumberAllocation@mhra.gsi.gov.uk. Include your company name and address or the company number issued by MHRA if you’re the current owner.
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.
Submit your application form with:
- the annex form to declare the marketing status of your product needed under the sunset clause
- a receipt of payment - you will need to pay the fee of £442 before submitting your application if you haven’t already
- sections 7 and 8 of the summary of product characteristics document
- current labels and leaflets with the new company’s name, address and application number
- a cancellation letter from the existing MA holder confirming the:
- cancellation date when the MA should be transferred, which can be up to 6 months following the grant of a new MA for the current holder to clear their stock
- a letter from the manufacturer saying they will continue to make the products for the new MA holder
- if this isn’t the case the new owner should include a letter of assurance that they will submit a variation form to delete the manufacturer from the MA
- a letter confirming all supporting information has been given to the new owner such as the cut-off date for data (data lock point)
- details of any risk minimisation duties under the terms of the current MA such as:
- pregnancy prevention programmes
- provision of educational material
- controlled distribution and specific monitoring
- plans for how any new activities will be met
Include your application number on each document.
See notes in the application form for help with completing it.
You must submit any changes made to the pharmacovigilance system and/or the qualified person responsible for pharmacovigilance as a variation after the change of ownership has been granted.
You should include any changes to the pharmacovigilance system and/or the qualified person responsible for pharmacovigilance in Europe. Any changes made after the change of ownership is granted must be submitted as a variation to the regulatory authority.
The application can take up to 42 days to process during which we may contact you with a request for information.
If you don’t respond within 14 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 need to contact MHRA by email email@example.com if a grant or request for information letter has not been received by the 30th day from the date the application was submitted.
MA expiry date
The expiry date on the current MA will remain the same when transferred unless it has less than 6 months left where it’s given a minimum period of 6 months.
All pending submissions such as a change to an MA (known as a variation) or a renewal application will be transferred over to the new MA.
Under the sunset clause MA owners must notify MHRA when they intend to market a medicinal product so that that our records are up-to-date. Owners should also notify us if the medicinal product is temporarily or permanently taken off the market.
The MA will no longer be valid for a product that hasn’t been placed on the market for 3 consecutive years. The time left to place a medicinal product on the market will be inherited by the new owner.
See the interpretation of directive 2001/83EC on the sunset clause (PDF, 22.8KB, 3 pages) for more information.
Email the regulatory information service team firstname.lastname@example.org with any queries.
Published: 18 December 2014
Updated: 18 April 2016
- Updated fees for 2016
- Submissions to apply to change a marketing authorisation will no longer be accepted by CD.
- First published.