The Health Products Regulatory Authority (the
"HPRA") has established a new compliance
programme in relation to Advisory Board meetings. This programme is
effective from 1 January 2021 and applies to Market Authorisation
Holders ("MAH").
The Irish Pharmaceutical Healthcare Association
("IPHA") has also included a new Annex
(Annex VI) on the conduct of Advisory Board meetings in its updated
Code of Practice for the Pharmaceutical Industry. These
developments make it clear that this area is coming under
increasing scrutiny from a compliance perspective.
1. Notification Requirement for an Advisory Board Meeting
The HPRA have stated that from 1 January 2021, MAHs or their
affiliates in Ireland must notify the HPRA (via email to [email protected])
in advance of holding any Advisory Board meeting in Ireland or
outside Ireland if the meeting is organised (in part or in full) by
MAHs or their affiliates in Ireland, and/or which include
healthcare
