Brexit – Unfettered Access Procedure (UAP)

Brexit – Packaging

Registering new packaging information for medicines Once you have been issued with your new Marketing Authorisation (MA) to convert a previously EU-wide MA to a MA for Great Britain, you will have 24 months (starting 1 January 2021) to establish and register a Great...
Brexit – MAH & QPPV Location

Brexit – MAH & QPPV Location

Marketing Authorisation Holder (MAH) and Qualified Person for Pharmacovigilance (QPPV) location Establishment of the MAH The MAH for a UK MA must be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA. An exception to this requirement applies in...
Brexit – Unfettered Access Procedure (UAP)

Brexit – MRP/ DCP Renewals

Today we’re looking at Renewals submitted for Marketing Authorisations (MAs) granted through Mutual Recognition Procedure/ Decentralised Procedure ( MRP/ DCP) (MHRA guidance can be found here.) What is the default position for MRP/ DCP MAs? The default position...
Brexit – Variations

Brexit – Variations

Now that the Brexit transition has taken place you may be wondering what your options are for submitting new variations or how your pending variations will be processed. Here is a summary of how Marketing Authorisations (MAs) will be handled according to the process...