Marketing Authorization Holders (MAHs) in the United Kingdom were provided and asked to submit any/all data and related information for all converted licenses in the electronic Common Technical Document (eCTD) format within just one (01) year starting from January 01, 2021.
By that timeline, if the renewal application is not submitted before December 31, 2021, the license will be considered canceled.
A converted central license that is required in the United Kingdom market, but one that has not had a submission made before December 31, 2021, can only be re-registered through the submission of a new application to the Medicines and Healthcare products Regulatory Agency (MHRA) and will require a new assessment to be completed before the product launch in the market.
If a converted license is to be canceled in the UK, the MHRA will request one (01) submission to be made with a request enlisted to cancel the CAP license, which is processed after recording the details of the basic license. Thus, the license canceled by the European Medicines Agency (EMA) before December 31, 2020, does not need to be registered again.
The submission package must comprise of only one (01) eCTD sequence for the converted EU MA(s), including the following documents:
- A cover letter that should label the submission a “CAP Grandfathering Submission” in the title and a statement that the license is to be canceled in the UK (mainland)
- Current labels, packaging design, and leaflets as approved by the EU procedure, which are:
- the outer packaging
- the immediate packaging
- the package leaflet
- A Summary of Product Characteristics, also known as the SmPC that is currently approved by the corresponding EU procedure in the PDF format as well as the SPC template
- A completed Electronic Application Form (EAF) for each converted EU MA
If more than a single dosage form is converted, it is expected that they will be submitted and handled as one eCTD dossier.
As the deadline is nearing, MAHs need to ensure that they submit a complete and compliant package to avoid any delays and rework. For end-to-end support in submission package creation, please reach out to a Regulatory expert like Freyr.