Regulatory Excellence: Delivered

Author Name:

Dr Lorraine Marsh

Posts made by this author are shown below.

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

Dr Lorraine Marsh
Dr Lorraine Marsh

Parallel Distribution Notices (PDNs) are no longer valid in Great Britain (England, Scotland, Wales) and are replaced by Parallel Import Licences which allow the products...

Brexit – Unfettered Access Procedure (UAP)

Dr Lorraine Marsh
Dr Lorraine Marsh

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...

Brexit – Packaging

Dr Lorraine Marsh
Dr Lorraine Marsh

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...

Brexit – MAH & QPPV Location

Dr Lorraine Marsh
Dr Lorraine Marsh

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...

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

Dr Lorraine Marsh
Dr Lorraine Marsh

There are now several routes to obtaining a Marketing Authorisation (MA) in the UK, Great Britain (GB – England, Scotland and Wales) or Northern Ireland...

Parallel Import Scheme

Dr Lorraine Marsh
Dr Lorraine Marsh

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...

Brexit – MRP/ DCP Renewals

Dr Lorraine Marsh
Dr Lorraine Marsh

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...

Brexit – Variations

Dr Lorraine Marsh
Dr Lorraine Marsh

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...

Brexit – Centralised Procedure

Dr Lorraine Marsh
Dr Lorraine Marsh

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...

PDF licences and certificates from MHRA

Dr Lorraine Marsh
Dr Lorraine Marsh

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...