Centrally Authorised Products
(CAP/Grandfathered MAs) holders
Action required before 31st December 2021
As the first year of GB being outside of the European regulatory system, draws to a close, we wish to remind our clients and holders of Centrally Authorised Products (CAP, also known as grandfathered MAs) that action is required before 31st December 2021.
6 weeks remain to submit an initiating/baseline eCTD sequence for any CAP conversion (also known as “Grandfathered”) MAs by the end of 2021. The eCTD baseline MUST reflect the details authorised and in place 31 Dec 2020. Any variations authorised since 01 Jan 2021 must be submitted as consequential sequences.
As the requirement to amend the MAH to one based in the UK was removed by the MHRA it is not be necessary to amend the artworks to add the new MAH BUT it is still necessary to add/amend the PLGB MA number. Additionally the MHRA have previously stated to us that they do not want to see references to the EMA in the PIL and local reps in EU member states, however the transition remains in place, update of mock-ups in the dossier are required by 1/1/2023 and only packs updated for the UK(GB) market being placed on the market from 1/1/2024.
There is still negotiation surrounding the Northern Ireland Protocol ongoing so further updates may follow. One thing that we have learnt is that it will not be necessary to decommission serialized packs before export to the UK(GB) from the 1/1/2022 as was previously stipulated; therefore barring any other changes it should be possible to supply EU packs [UK(NI)] to GB for the time being.
If you need any advice or help with interpretation of the grandfathered medicines and the MHRA requirements to maintain the PL GB MA after 31 Dec 2021 please contact us via firstname.lastname@example.org