Latest guidance on the importing of medicines and devices into Northern Ireland after Brexit

A combination of newly released and recently updated guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) clarifies the requirements and procedures for the importing of medicines and devices into Northern Ireland (NI) following the end of the transition period. Read more “Latest guidance on the importing of medicines and devices into Northern Ireland after Brexit”

HPRA details time-limited conditional exemptions to facilitate supply of medicines to the Irish market after Brexit

Ireland’s Health Products Regulatory Authority (HPRA) has outlined conditions in which Marketing Authorisation Holders (MAHs) can apply for a time-limited conditional exemption to the implementation of new rules following Brexit. Read more “HPRA details time-limited conditional exemptions to facilitate supply of medicines to the Irish market after Brexit”

European Commission Decision Reliance Procedure provides a new route to obtain marketing authorisations in Great Britain

For two years from 01 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) may rely on Marketing Authorisations (MAs) approved by the European Commission (EC) via a centralised procedure when assessing an application for a Great Britain (GB) MA. The MHRA have released guidance on applying for a GB (England, Scotland and Wales only) MA through this route. Read more “European Commission Decision Reliance Procedure provides a new route to obtain marketing authorisations in Great Britain”

MHRA release guidance on the decentralised and mutual recognition reliance procedure for marketing authorisations

Following the end of the transition period, the Medicines and Healthcare products Regulatory Agency (MHRA) have released guidance on how to obtain a marketing authorisation (MA) in the United Kingdom (UK) or Great Britain (GB) using the decentralised and mutual recognition reliance procedure (MRDCRP). Read more “MHRA release guidance on the decentralised and mutual recognition reliance procedure for marketing authorisations”