Abstract

The 2019 IPEC Europe Annual Excipient Forum took place on 31 January in Malta, providing current insights into the commercial, regulatory and scientific issues affecting both suppliers and users of pharmaceutical excipients. IPEC Europe’s chair, Frithjof Holtz, welcomed participants and highlighted some new developments in IPEC Europe, namely how its brand relaunch in 2018 has now been complemented with a more modern user-friendly website.

A common theme running through several presentations in the programme is integrity in its various guises. Whether integrity issues relate to the very ‘now‘ subject of data management or equally, the movement of goods through ever complex and global supply chains, it’s a subject that appears on many agendas.

First up was Dr Peter Gough, Executive Director, NSF Health Sciences, addressing the very dynamic subject of The Potential Impact of Brexit on Pharmaceutical Supply Chains. Peter reminded us that aside from potential stock-out situations, the relocation of the European Medicines Agency (EMA) to Amsterdam is having a huge impact on licensing activities. Particularly, many Marketing Authorisation (MA) holders are having to establish a base in another EU member state and reassignment of MA rapporteurs which were assigned to the UK. After the exit date, the UK’s MHRA plans to more or less maintain the status quo, at lease for an interim period, automatically granting marketing authorisations for currently approved products but basic information must be provided within one year. UK will accept product testing and authorisation by EU/EEA Qualified Persons (QPs). C ...