Pharmaceutical firms have been asked to provide the UK regulatory agency, the MHRA, with details of the current UK marketing status of each of their EU centrally authorized products (CAPs) and to identify those that they do not wish to continue marketing in Great Britain from next year.
Under guidance published in September, all existing CAPs will automatically be converted into Great Britain marketing authorizations on 1 January 2021, although CAPs will continue to be valid in Northern Ireland. 1 January is the day after the end of the Brexit transition period, when the UK leaves the EU single market and customs union. (Also see "UK Regulator Explains Data Requirements For Converted EU Approvals" - Pink Sheet, 9 Sep, 2020.)
Under the “grandfathering” process, the MHRA will assign all converted CAPs a Great Britain Product License (GBPL) number based on current practice for nationally approved drugs. However, if companies do not want any of their CAPs to be converted, they will have three weeks from 1 January to opt out.
In a letter addressed to company heads of regulatory affairs, the MHRA says that to make sure the conversion process runs smoothly, companies should review their currently authorized CAPs (all of these are listed in an annex to the letter) and advise it of any errors or omissions. They should also say whether each of the products is currently marketed in GB, and identify any products or presentations that have been withdrawn or cancelled.
Change Of Ownership
Companies are also requested to inform the MHRA of the number of GBPLs they will need if they are planning to make a change of ownership application. The change of ownership process is particularly important because from next year companies will need to be established in the UK as well as the EU to continue marketing their products in the UK.
If they have not already done this, they have until the end of 2022 to do so (under the so-called standstill period). In the meantime, they will have to provide the MHRA with details of a contact in the UK.
The MHRA "will publish a list of products that have and have not been converted as a result of this exercise" – MHRA guidance
Any marketing authorization holders (MAHs) that do not want a GB license for a CAP should advise the regulator as soon as possible. “MAHs can opt out of the conversion process for all or some of their CAPs by notifying the MHRA in writing by 21 January 2021,” the agency says in the letter. “If an MAH chooses to opt out, after 21 January 2021 their product(s) will no longer be licensed in Great Britain. This will mean they can no longer be placed on the market in Great Britain.”
According to the September guidance, the MHRA "will publish a list of products that have and have not been converted as a result of this exercise."
The agency also points out that marketing authorizations for CAPs that are not currently marketed in the EU or GB can still be converted, in which case the sunset clause period – which states that products must be marketed within three years of approval or risk losing their license – will begin from the date of conversion into a GB MA.
No fee will be charged for CAP conversions, although the standard periodic fee will be payable starting from 1 April next year.
The MHRA has also published guidance on how companies should apply for renewals of converted CAP and other marketing authorizations (Also see "UK Explains Approach To Renewing Converted EU Drug Approvals in 2021" - Pink Sheet, 4 Sep, 2020.)