The change of ownership scheme is used when a company wishes to transfer a licence from one company to another that is one legal entity to another. To ensure that the MHRA has sufficient time to close all applications on the old licence please give as much warning as possible of any proposed changes of ownership. Where possible variations should not be submitted once a change of ownership has been applied for.
Complete MLA201 COA form 
(48Kb)
1. A new product licence (PL) number is required to be entered on the application form and this should be requested from 020 3080 6646 or email Submissions.Centre@mhra.gsi.gov.uk.
2. Effective date is entered on page 1a of the form. (COAs take approx six weeks to process)
3. A cancellation date is entered on page 1b and this can be up to six months following grant of new licence for the purpose of clearance of existing stock.
4. An expiry date should be added to the form. Details of what this should be are given below:
- If the marketing authorisation (MA) is a mutual recognition applicationthe new MA will have the same expiry date as the old MA.
-If the MA is a national authorisation
Has it been renewed previously?
No
The new MA will have the same expiry as previous MA. If there are less than six months remaining to the expiry date for the old MA please add 6 months from the effective date.
Yes:
Was the renewal granted?
- Yes, the new MA will have unlimited validity. Please write unlimited validity (on portal form leave blank and add a statement regarding unlimited validity to the comments section)
- No, please put an expiry date of six months from the effective date.
5. A letter from manufacturer (if not the applicant) should be supplied saying that they are prepared to manufacture on behalf of the new licence holder. If the manufacturer is not going to be used or no longer exists an assurance should be provided that a variation will be submitted once the new licence is granted.
6. A letter from applicant should be provided confirming that all supporting data is in their possession. This includes all ADRs reports and details of data lock points for Periodic Safety Update Reports (PSUR) submissions.
This letter should also specify whether the COA will result in a change to the pharmacovigilance system and/or EEA Qualified Person Responsible for Pharmacovigilance (QPPV). If changes will occur, the applicant should confirm that following the COA grant, the MAH will notify the Licensing Authority in accordance with the new variations regulation.
7. If any risk minimisation activities are attached to the existing Marketing Authorisation (eg a pregnancy prevention programme, provision of educational material, controlled distribution, specific monitoring etc.), a summary of the risk minimisation activities should be provided, together with a plan of how the applicant intends to fulfil the commitments.
8. If there is more than one legal category on an existing licence then separate applications must be submitted if both or all three legal categories are required. Pack sizes or indications should be amended accordingly.
9. Labels and leaflets should be submitted with the application. See Special MAIL 3 (page 5, item 8.7).
10. Ideally no variations should be outstanding when a COA is submitted. The MHRA are able to process the COA and copy the variation(s) to the new licence. The fee for the ‘old’ variation will be refunded and the fee applied to the ‘new’ variation. The new MA holder will be held responsible for settling invoices on any pending variations transferred.
11. Ideally all renewal and PSUR applications will be completed but in cases where this has not been possible the outstanding renewal/PSUR will be transferred to the new licence. Additional information will be required for renewal applications - please see the renewals page of the website for further information.
12. Electronic applications should be sent to Submission Centre, Area 1, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ.
13. Current fee should be sent to The Cashier, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ ensuring the new PL number is quoted and not the old one.
If further information is required please contact Mr Aidan Hardy on 020 3080 6693 or email: aidan.hardy@mhra.gsi.gov.uk or Mr William Whitfield on 020 3080 6163 or email william.whitfield@mhra.gsi.gov.uk
