The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its Guidance for CAPs with further information on the submission process for licenses that have been canceled in mainland UK between 31 December 2020 and 31 December 2021.
Since 01 January 2021, Marketing Authorization Holders (MAHs) have had a period of one year to submit all data and relevant information in electronic Common Technical Document (eCTD) format for all converted licenses. If an application is not submitted before 31 December 2021, the license will be considered to be canceled.
Converted centralized licenses that are required on the UK market but have not been submitted prior to 31 December 2021 must be re-registered through the standard submission process. The application to the MHRA will be subject to normal costs and a new assessment prior to marketing authorization.
If a converted license is to be canceled in the mainland UK, a basic submission (see the requirements below) must be made with a request to cancel the CAP license. The submission will be processed only after the basic license details have been recorded. This step is necessary for the MHRA database to build its record for all licenses that were converted to national licenses on 01 January 2021. Any licenses that were canceled by the EMA before 31 December 2020 do not need to undergo this process.
Submission requirements for converted licenses that should be canceled before 01 January 2022
As outlined by the official MHRA Guidance, the data submission package must contain the following:
a) a single eCTD initiating sequence for the converted EU MA(s) containing the following documents. If more than one dosage form or strength is converted for the same product trade name, the expectation is that these will be handled as one eCTD dossier.
b) Cover Letter: The Cover Letter must contain a title that clearly designates the submission as a “CAP Grandfathering Submission.” It should also include a statement clarifying that the license should be canceled in
c) a completed electronic application form (eAF) for each converted EU MA.
d) the Summary of Product Characteristics (SmPC) currently approved by the corresponding EU procedure both in PDF format and in the SPC template.
e) the packaging labels and leaflet as currently approved by the corresponding EU procedure, which are:
I. the outer packaging of the medicinal product;
II. the immediate packaging of the medicinal product; and
III. the package leaflet for the medicinal product.
The Guidance asks that if a CAP submission was made before November 2021 and you have not received an approval letter by 01 December 2021, to please contact the MHRA customer service team to ensure that the application is completed before the deadline.
For the complete Guidance, visit the MHRA Guidance Page.
If you have any questions, need further information, or require support, please feel free to contact us.