GovWire

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.

Apply to change the ownership of anMA

You need to request an application number for all documents by emailing us beforehand atPLNumberAllocation@mhra.gov.uk. Include your company name and address or the company number issued by MHRA if youre the current owner.

You need to follow theeCTD standardswhen submitting your application.

Supporting documents

Your Change of Ownership Submission must include:

• The application form, which must be completed in line with the guidance provided on its pages 4, 5 & 6. Please note that each product must have its own individual application form, however products that currently share the same dossier can be submitted in the same sequence. In such cases include all application forms in the m.1.2 folder of the eCTD structure.
• A cover letter including all relevant information (present and proposed MAH, present and proposed PL, present and proposed product name, date for the COA grant, date for the existing licence cancellation, etc). If more than one product is being included in the submission, please mention all of them in the cover letter. Please include the Cover letter in the M.1.0 folder of the eCTD structure.
• A Letter from Dosage Form Manufacturer(s) (if not the applicant) confirming that they are prepared to manufacture the product on behalf of the proposed MAH. If the manufacturer is not going to be used or no longer exists a declaration should be provided by the proposed MAH that a variation will be submitted to delete the manufacturer(s) once the new licence is granted. Please Include this document in the additional data folder of the eCTD structure
• A cancellation letter if your submission is via the MHRA portal. The letter stating the date for the cancellation of the license which can be any time from immediately following the COA grant or any date up to 6 months from the COA grant. The letter must be signed by authorised signatory of the current MAH. Please note that if your submission is via the MHRA Submissions Portal the cancellation date will be included in the application form and therefore a cancellation letter is not mandatory. Please include this document in the additional data folder of the eCTD structure.
• The Annex 1 Declaration of marketing status for Change of ownership. Choose the relevant option, enter the PL number (if more than one product is being included in the submission please include all the PL numbers in the COA PL number field), the proposed MAH must sign the document. Please include this document in the additional data folder of the eCTD structure.
• The Patient Information (PI) - leaflet and label - updating the MAH details and PL number to reflect the change of ownership, logos may be removed and/or replaced by previously authorised logo. No other changes will be accepted and will lead to invalidation of your submission

Please ensure to include the PI (either mock-ups and/or QRD version as applicable) in PDF format in the M.1.3 folder of the eCTD structure otherwise your submission will be found invalid.

• If your product is going to be marketed within to 30 days of the COA grant the label and leaflet must be submitted as mock-ups, however we can only accept mock-ups if the current license has mock-ups approved.
• If the product is not going to be marketed the following the COA grant the label and leaflet can be submitted either as mock-ups or/and QRD in PDF format. If QRD only is submitted the MAH will have to submit a PIQ application to implement the mock-ups prior to marketing the license.
• If the current license is not marketed and the current granted PI are in QRD format we will not be able to accept mock-ups during the COA. The applicant must submit QRD version during the COA and submit a PIQ application to implement the mock-ups prior to placing the product in the market.

Supporting information

Changes to the pharmacovigilance system and/or the UK qualified person responsible for pharmacovigilance (QPPV) may be made as part of the COA application process or may be submitted as aType IA(IN) variationafter the change of ownership has been granted:

1. If you wish to submit the changes to the UK PSMF number (and associated information) for an MA as part of a COA application, a copy of the updated summary of the applicants pharmacovigilance system (SPS) must be included under module 1.8.1 of the COA dossier. This update should also include information regarding changes to the UK QPPV details and UK location of the UK PSMF.
2. If you wish to submit the changes to the UK PSMF number (and associated information) after grant of the COA and not as part of the COA dossier, a Type IA(IN) notification containing the updated SPS should be submitted within 14 days after the change of ownership has been granted.

Any subsequent changes to the pharmacovigilance system made after the change of ownership is granted must besubmitted as either an SPS Update Notification or Type IA(IN) variationto the regulatory authority within 14 days of the change taking effect (see also Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)).

If no changes to the pharmacovigilance system and/or the UK QPPV are anticipated to take place due to the change of ownership, the applicant must nevertheless confirm these details to the MHRA by submitting a copy of the applicable SPS either as part of the COA dossier or via a Type IA(IN) variation within 14 days of COA application grant.

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 toReference.Data@mhra.gov.uk, including the company details and a suitable email address.

If you dont 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 emailRIS.NA@mhra.gov.ukif a grant or request for information letter has not been received by the 25th day from the date the application was submitted.

MAexpiry date

The expiry date on the currentMAwill remain the same when transferred unless it has less than 6 months left where its given a minimum period of 6 months.

All pending submissions such as a change to anMA(known as a variation) or a renewal application will be transferred over to the newMA.

Seefurther information about the sunset clause, under whichMAowners must notify MHRA when they intend to market a medicinal product.

Email the regulatory information service teamris.na@mhra.gov.ukwith any queries.