After Brexit became effective on 1st January 2021, all existing EU product MAs obtained through Centralized procedure (CAP) have been automatically converted into UK MAs (“grandfathering”) effective in Great Britain (only) and issued with a UK MA number on 1st January 2021. As a result of the implementation of the Northern Ireland Protocol, existing CAPs will remain valid for marketing products in Northern Ireland.
In light of this, the challenge for companies is to complete the action plan transversally involving several functions (RA, PV, QA and Supply Chain) to fulfil all the obligations requested by MHRA. These obligations, which have different deadlines for implementation, include:
- Company registration into MHRA portal and initiating sequence submission within the period of one year starting on 1st January 2021.
- Change of ownership application to establish an MAH in the UK within 24 months starting on 1 January 2021.
- New UK artworks creation within 36 months in total from 1st January 2021 to ensure all stock released to market is in compliant packaging.
PV Activities management and UK based QPPV contact person. From 1st January 2021 the MAH will be responsible for submitting the following pharmacovigilance data and documentation to the MHRA for medicines authorised in GBMoreover, MAH must nominate a national contact person for pharmacovigilance who resides and operates in the UK and reports to the QPPV within 12 months from 1st January 2021.
Regulatory Pharma Net team is available to fully support companies in preparing and implement the appropriate cross-functional action plan to make any Marketing Authorization compliant to the MHRA requirements.