Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs)

Parallel Distribution Notices (PDNs) are no longer valid in Great Britain (England, Scotland, Wales) and are replaced by Parallel Import Licences which allow the products to be marketed in Great Britain only. The MHRA has provided guidance for the process which they have put in place to convert PDNs into Parallel Import Licences for Great […]

Brexit – Unfettered Access Procedure (UAP)

What is the Unfettered Access Procedure (UAP)? Applicants may seek recognition in Great Britain of a marketing authorisation (MA) approved in Northern Ireland. The UAP is the route available for MAs approved in Northern Ireland via EU (centralised, mutual recognition or decentralised) procedures or through the national procedure, if the marketing authorisation holder is established […]

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 Britain presence for your MA. This will include submitting amended artwork […]

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 the case of an application for a Great Britain MA made through […]

Brexit – Routes to obtaining an MA in UK/ NI/ GB

There are now several routes to obtaining a Marketing Authorisation (MA) in the UK, Great Britain (GB – England, Scotland and Wales) or Northern Ireland (NI), which fall into 2 main camps – National and International:   What are the National routes? Innovative Licensing and Access Procedure (ILAP) – this aims to accelerate the time […]

Parallel Import Scheme

What is the UK parallel import licensing scheme? The UK parallel import licensing scheme lets a medicine authorised in European Economic Area (EEA) Member State be marketed in the UK, as long as the imported product has no therapeutic difference from the cross-referenced UK product. What do you need if you want to parallel import […]

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 for MRP/ DCP licences is to maintain a UK-wide MA and retain UK in respect of Northern […]

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 by which they were licenced. How will Mutual Recognition/ Decentralised (MR/ […]

Brexit – Centralised Procedure

Today we’ll be looking at how licences authorised via the EU centralised procedure are going to be handled. All existing Marketing Authorisations (MAs) authorised through the centrally authorised procedure (CAP) will automatically be converted into UK MAs. These MAs will be issued with a UK MA number before the end of the transition period. Companies […]

PDF licences and certificates from MHRA

Staff at the MHRA are working from home so they are issuing electronic pdf copies of licences and certificates, however entries will continue to be uploaded to EudraGMDP… click here