On 17 November 2023, the UK MHRA published updated guidance on change of ownership of Medicines Marketing authorisation, to reflect a new process and application form.
This post is an attempt to provide the updated guidance information in a more user friendly format.
For a Change of Ownership Application of Marketing Authorisation, the following steps apply:
1. Request an application number
You need to request an application number for all documents by emailing th eMHRA beforehand at PLNumberAllocation@mhra.gov.uk.
Include your company name and address or the company number issued by MHRA if you’re the current owner.
2. Prepare the application(s)
You need to follow the eCTD standards when preparing your application.
To prepare an application(s), you will need supporting documents and may need supporting information as detailed in the table below.
| Item | Further information | eCTD folder to which document(s) must be added |
|---|---|---|
| Supporting documents | ||
| Application form | Complete in line with the guidance provided on pages 4, 5 & 6 of the application form. Each product must have its own individual application form. However, however products that currently share the same dossier can be submitted in the same sequence. | M1.2 folder |
| Cover letter | Include all relevant information including the following: · present and proposed MAH, · present and proposed PL, · present and proposed product name, · date for the COA grant, · date for the existing licence cancellation If more than one product is being included in the submission, please mention all of them in the cover letter. | M1.0 folder |
| A Letter from Dosage Form Manufacturer(s) (if not the applicant) | 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. | Additional data folder |
| Cancellation letter | To be included if your submission is via the MHRA portal. The letter: · should state state 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. · 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. | Additional data folder |
| 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. | Additional data folder |
| 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 Important: Include the PI (either mock-ups and/or QRD version as applicable) in PDF format, otherwise your submission will be invalidated. | M.1.3 folder |
| 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 a Type IA(IN) variation after the change of ownership has been granted: | |
| Changes to the UK PSMF number (and associated information) for an MA as part of a COA application* | 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 applicant’s pharmacovigilance system (SPS) must be included · This update should also include information regarding changes to the UK QPPV details and UK location of the UK PSMF. | M1.8.1 folder |
*See table below for what what to do if you wish to submit these changes are COA grant or if no changes to the pharmacovigilance system and/or QPPV are anticipated to take place due to the change of ownership.
| Change type | What to submit |
|---|---|
| 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 | Submit a Type IA(IN) notification containing the updated SPS should be submitted within 14 days after the change of ownership has been granted. |
| If you wish to submit any subsequent changes to the pharmacovigilance system made after the change of ownership is granted. | These must be submitted as either an SPS Update Notification or Type IA(IN) variation to 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)). |
| No changes | |
| 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. |
3. Submit the application(s)
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. In order to do this, You will need to register if you haven’t done so already.
4. Processing time for the application(s) and Validation Correction Request (if applicable)
The application can take up to 42 days to process during which the MHRA may contact you with a Validation Correction Request (VCR) for information.
- If you wish to receive electronic communication (eCOMMS) and are not yet registered to do so, 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, the MHRA 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.
Marketing Authorisation Expiry Date of the current MA
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.
See further information about the sunset clause, under which MA owners must notify MHRA when they intend to market a medicinal product.
Email the regulatory information service team ris.na@mhra.gov.uk with any queries.
Source: MHRA