All existing CAP MAs will automatically be converted into UK MAs and issued with a UK MA number on exit day. These UK MAs are referred to in this guidance as “converted EU MAs”.
MAHs can choose to opt-out of the conversion process for all or some of their CAPs by notifying the MHRA in writing following which those UK MAs will be revoked. The details of how to exercise that option can be found in the first letter in November 2018. You must let the MHRA know if you wish to opt-out by 21 days after exit day.
If the MAH chooses to opt-out, their product(s) will no longer be licensed and must not be marketed in the UK. The MHRA will publish a list of products that have and have not been converted as a result of this exercise.
To support the ongoing regulation of these converted EU MAs, the MHRA needs essential baseline data to be submitted in the form of an initiating electronic Common Technical Document (eCTD) sequence together with certain other related MA-specific information for each converted EU MA.
MAHs will have a period of one year starting on exit day to submit this data and related information in eCTD format. Until these initiating sequences are submitted and processed, it will not be possible to submit a variation for the converted EU MA unless there are exceptional circumstances relating to public health. There is no fee for the grandfathering process.
As with all national MAs, an annual service fee will be due for converted EU MAs from 1 April 2020 unless the MAH opts out by the required date.